Global Needlestick Prevention Group Honors Award Recipients as It Marks 6th Annual International Sharps Injury

SOUTH JORDAN, UT, Nov 30 (MARKET WIRE) -- ISIPS, the first international sharps injury prevention group, announced that seven recipients are being honored for reducing sharps injuries with a Sharps Injury Prevention Award with an additional 22 recipients receiving honorable mention awards. These awards are part of the International Sharps Injury Prevention Awareness Month activities being commemorated during December, 2007 starting with World AIDS Day, December 1st.
A number of very worthy individuals were nominated for the ISIPS 2007 International Sharps Injury Prevention Awards. Nominations were reviewed bya nominating committee, comprised of representatives from Terumo Medical, Covidien, Inviro Medical, BD, Retractable Technologies Inc., Owen Mumford,Medical Device Manufacturer (Thailand), Managing Infection Control magazine and the International Sharps Injury Prevention Society (ISIPS).

read the full article>> http://www.reuters.com/article/pressRelease/idUS8046+30-Nov-2007+MW20071130

Radiologists Receive Limited Radiation Exposure While Performing CT-Guided Percutaneous Radiofrequency Tumour Ablation: Presented at RSNA

By Ed SusmanCHICAGO, IL -- November 30, 2007 -- Radiologists who perform percutaneous radiofrequency ablation procedures using computed tomography (CT) to guide the way to the tumour are not being exposed to excessive amounts of radiation when they use normal precautions such as working behind leaded windows.At the 93rd Scientific Assembly and Annual Meeting of the Radiological Society of North America (RSNA), researchers presented the results of a study that evaluated radiation exposure to operators involved in interventional CT fluoroscopy performed in patients with solid tumours.

full article>> http://www.docguide.com/news/content.nsf/news/852571020057CCF6852573A30058D11B

Provensis continues Phase II trials of Varisolve foamed polidocanol

more information >> http://clinicaltrials.gov/ct/show/NCT00442364;jsessionid=011CCDBB7C8ECE00AE774A290D77105A?order=7

Cook Medical Launches EVOLUTION(R) for Lead Extraction

Innovation in lead extraction unveiled at the XIII World Congress for Cardiac Pacing in Rome on December 2nd
BLOOMINGTON, Ind.--(HSMN NewsFeed)--Cook Medical today launched the EVOLUTION® Mechanical Dilator Sheath Set. The first showcase for this innovation in lead extraction will be at the XIII World Congress on Cardiac Pacing and Electrophysiology in Rome, Italy on December 2nd and 6th.
By the end of 2007, approximately 750,000 leads will have been implanted in patients with pacemakers and defibrillators across Europe. In Europe, 30,000 to 52,000 of these leads will need to be extracted as a result of damage, infection or the inability to implant new leads due to the presence of existing ones. In the U.S., more than 20,000 to 25,000 leads are extracted annually. Currently, leads can be removed either using laser extraction systems or with a ‘snare’ under local or general anaesthetic, both extraction methods may have disadvantages in terms of cost, time and or potential patient adverse events.

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Toshiba majors on triple-play CT

The latest advances in CT technology are as much about minimizing X-ray dose and speeding up exam times as they are about improvements to image quality. That "triple-play" mantra appears central to the thinking behind the 320-slice AquilionONE CT scanner debuted by Toshiba America Medical Systems (Tustin, CA) at the Radiological Society of North America (RSNA) annual meeting in Chicago, IL, this week.
The works-in-progress CT machine can scan an entire organ – the heart or the brain, for example - in one rotation because it covers up to 16 cm of anatomy using 320 ultra-high-resolution 0.5 mm detector elements.
This capability (dubbed dynamic volume CT) is advantageous on two levels. First, it reduces motion artefacts significantly, eliminating the need to reconstruct slices from multiple points in time. What's more, Toshiba says AquilionONE technology involves considerably less radiation exposure - when compared against conventional CT coronary angiography, for example - owing to the elimination of overlapping CT slices.

read the full article >> http://medicalphysicsweb.org/cws/article/industry/32028

J&J again sues Abbott in bid to keep stent off U.S. market

In a bid to stop the introduction of a competing device, Johnson & Johnson's Cordis unit has sued Abbott Laboratories for the fourth time this year over a patent for drug-coated heart stents.
The suit claims that Abbott's Xience coated stent would infringe a patent for a way of using rapamycin or related medicines on the devices to prevent growth of scar tissue in arteries that have been cleared of fat. Rapamycin is used to coat Johnson & Johnson's Cypher stent. The Xience uses everolimus, which Johnson & Johnson says is a related drug.

read the full article >> http://www.startribune.com/535/story/1579733.html

Renal Solutions, Inc. Announces Acquisition by Fresenius Medical Care

WARRENDALE, Pa., Nov. 29 (HSMN NewsFeed) -- Renal Solutions, Inc. (RSI) announced today that the Company has been acquired by Fresenius Medical Care AG & Co. KGaA. RSI will continue operations as a wholly owned subsidiary of Fresenius Medical Care, the largest integrated global provider of dialysis products and services. Peter DeComo will continue to lead RSI operations in Warrendale, PA and Oklahoma City, OK.

Renal Solutions is the innovator in the field of sorbent dialysis therapy. The Company's sorbent technology is based on a more than 35-year history of proven dialysis therapy and enables flexible treatment options using only 6 liters of drinking water. RSI holds a number of key patents and other intellectual property related to sorbent dialysis therapy and has recently launched its Sorbent Management for Advanced Renal Replacement Therapy (SMARRT(TM)) platform.

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Smiths Medical Inks 3-Year Contract

DURHAM, N.C., Nov 27, 2007 (ASCRIBE NEWS via COMTEX) -- SMGKF charts news PowerRating -- Smiths Medical, part of the global technology business Smiths Group, announced that it has been awarded a three-year contract with Premier Purchasing Partners to offer its PORT-A-CATH Implantable Access Systems to Premier s 1,700 hospitals and more than 49,000 other healthcare sites.
The agreement runs through October 31, 2010.
We are very pleased that our PORT-A-CATH systems will now be available to Premier facilities, said Jim Stitt, President of Smiths Medical MD, Inc. in St. Paul, MN, and we are confident that Premier will discover the same proven performance of Smiths Medical portal access systems that millions of other customers around the world have come to trust.

read the full article: http://www.tradingmarkets.com/.site/news/Stock%20News/861731/

Covidien Launches First-In-Class, Questra-Based Valleylab(TM) Exchange Software Update System

Leader in Energy-based Surgical Systems Uses Intelligent Device Management to Streamline Software Delivery to Support New Instruments and Technologies

BOULDER, Colo. and REDWOOD CITY, Calif., Nov. 28 /PRNewswire-FirstCall/ -- Covidien Ltd. , a world leader in advanced energy-based surgical systems, and Questra Corporation, the leader in Intelligent Device Management (IDM), today announced the global launch of the Valleylab(TM) Exchange Software Update System.
The first remote update system in the electrosurgical market today, the Valleylab(TM) Exchange Software Update System is a convenient, cost-effective method for hospitals to remotely update the software on the ForceTriad(TM) energy platform. Hospitals can extend the capabilities of the energy platform and add support for new surgical instruments with this system, which updates software through secure electronic communications via RS-232 ports. They may also conduct updates over the Internet at their facility -- without needing to send the surgical unit to a center or depot.

read the full article: http://money.cnn.com/news/newsfeeds/articles/prnewswire/AQW07428112007-1.htm

Targeting the tumor: New procedure injects radiation directly into liver

Doctors are taking an inside track to treat liver cancer. For more than a year, three Peoria doctors have been performing selective internal radiation therapy at OSF Saint Francis Medical Center. SIRT is a cutting-edge treatment that attacks tumors from the inside of the liver. It allows higher doses of radiation to be concentrated on small areas of the organ.

read the full article: http://www.metrowestdailynews.com/health/x540385556

Toshiba Unveils New Low-Contrast X-Ray Imaging Feature at RSNA

New Feature Available on Infinix-i X-ray Systems Improves Visualization of Soft Tissue

CHICAGO--(HSMN NewsFeed)--Toshiba America Medical Systems, Inc., a leader in diagnostic and medical imaging, will unveil its new low-contrast imaging feature (510k pending) available on all Toshiba InfinixTM-i large panel X-ray systems at the Radiological Society of North America (RSNA) annual meeting in Chicago, Nov. 25 – 30 (Booth # 7130).

“As an industry leader in low-contrast imaging for CT, Toshiba is proud to leverage this expertise to bring exceptional low-contrast imaging capabilities to X-ray,” said Robert Micer, director, X-Ray Vascular Business Unit, Toshiba. “Toshiba’s new low-contrast imaging feature for the Infinix-i X-ray line can achieve better images of all soft tissues, including brain tissue, cerebral ventricles and hepatic visualization, thus allowing patients to be imaged and treated more quickly and accurately.”
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Cardinal Health Signs Agreement with Novation for Presource(R) Custom Procedure Kits, Procedure Based Delivery Systems

DUBLIN, Ohio, Nov. 28 (HSMN NewsFeed) -- Cardinal Health, a global provider of products and services that improve the safety and productivity of health care, today announced a three-year dual source agreement with Novation, the industry's leading contracting services company, to provide Presource® custom procedure kits and Procedure Based Delivery System (PBDS(TM)) modules to the 11,500 hospital and surgery center members of the University HealthSystem Consortium (UHC), VHA and Provista.

Under the agreement, which is effective February 1, Cardinal Health will supply these customers with Presource® kits and PBDS(TM) modules for all areas within the acute care hospital and surgery center environment, including the operating room, labor and delivery, cardiac catheterization lab and interventional radiology lab.

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Merit Medical Announces 510(k) Notification for Two Additional Products

SOUTH JORDAN, Utah, Nov. 28, 2007 (HSMN NewsFeed) -- Merit Medical Systems Inc. (NasdaqGS:MMSI ), a leading manufacturer and marketer of proprietary disposable devices used primarily in cardiology and radiology procedures, announced today that it has received notification from the FDA of 510(k) clearance for the All Star(tm) hemostasis valve and the Prelude(tm) marker tip introducer sheath.

The All-Star(tm) hemostasis valve's patented design maintains a fluid-tight seal around interventional devices. It allows the user to one-handedly manipulate wires and catheters without completely opening the valve, thereby reducing patient blood loss.The Prelude(tm) marker tip introducer sheath allows visualization of the sheath tip for precise placement during interventional and diagnostic procedures.

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Boston Scientific Launches Power Injectable PICC

Xcela Power Injectable PICC

Sizes: 4 F or 5 F x 45 or 55 cm single
5 F dual x 45 or 55 cm

Injection rates: 4 F single = 3.5 or 4 mL/sec
5 F single = 5 mL/sec
5 F dual = 4 mL/sec

5 different kit configurations

read more >> http://www.bostonscientific.com/templatedata/imports/HTML/Oncology/Xcela/Xcela_landing%20page.htm

Panel to Review Abbott Labs' Stent Data

NEW YORK (Associated Press) - The Food and Drug Administration said Tuesday it will ask an outside panel of medical experts whether clinical trial data submitted by Abbott Laboratories in support of its proposed cardiac stent Xience is enough to show it's safe and effective.
The panel also will be asked if patients in ongoing clinical studies of the drug-coated stent should be followed for a longer period of time before the agency considers approving the device.
The stent faces a review Thursday by the panel, which will make recommendations on whether the FDA should approve the device. The FDA usually follows its panel's advice but is not required to do so.
Most of the clinical studies compared Xience to Boston Scientific Corp.'s Taxus drug-coated stent, and involved about 1,000 patients. The bulk of the data pertains to patient outcomes after one year, although Abbott recently submitted additional data on 422 patients who have had the Xience stent for two years, compared with 181 patients with the Taxus stent.

read the full article: http://money.cnn.com/news/newsfeeds/articles/apwire/3bbcd324e874360058102a5c24db2e4f.htm

Endocare Announces That National Cancer Institute to Sponsor Study Comparing Cryoablation to Radiation Therapy for Pain Relief in Bone Cancer Patients

IRVINE, Calif., Nov. 27 /PRNewswire-FirstCall/ -- Endocare, Inc. , an innovative medical device company focused on the development of minimally invasive technologies used by urologists and interventional radiologists for tissue and tumor ablation, announced today that the National Cancer Institute (NCI) of the National Institutes of Health (NIH) is supporting a multi-center study comparing the pain-reducing palliative effects of cryoablation and radiation therapy for patients who are experiencing focal pain from cancer that has metastasized to their bones. The prospective, randomized study, called Cryoablation And Radiation Effectiveness (CARE) for Bone Pain and led by interventional radiologist Matthew Callstrom, M.D., PhD, of Mayo Clinic, will evaluate the efficacy of percutaneous cryoablation compared to external beam radiation therapy (RT) as measured by pain relief, quality of life, analgesic use and complication rates. Dr. Callstrom is also leading another multi-center study on cryoablation of painful metastatic disease.

read the full article: http://money.cnn.com/news/newsfeeds/articles/prnewswire/LATU13227112007-1.htm

Confirma Previews First Ever Prostate-Specific Computer-Aided-Detection (CAD) System for MRI and Introduces Next-Generation CAD for Breast MRI

CHICAGO--(BUSINESS WIRE)--Confirma®, pioneer and leader in application-specific CAD for magnetic resonance imaging (MRI), today announced that it will preview CADstream improved analysis and reporting of the prostate. The prostate application will offer radiologists comprehensive and clinically valuable tools for improved quality, standardization and efficiency in MRI study analysis and reporting. The company also introduced the next generation of CADstream for breast MRI, which features a customizable, BI-RADS®-centric user interface, improved morphology tools and patient monitoring capabilities.
Additionally, the company is previewing the Access Breast Coil®, which delivers high-quality diagnostic capability, flexible interventional access and optimized patient comfort. CADstream for breast and prostate and the Access Breast Coil are being presented at this week’s Radiological Society of North America (RSNA) meeting, the pre-eminent event for introducing new technologies for radiology (November 25-27, Chicago, booth 7950, North Hall).

read the full article: http://www.businesswire.com/portal/site/google/index.jsp?ndmViewId=news_view&newsId=20071127005038&newsLang=en

CellSearch(TM) Circulating Tumor Cell Kit Receives FDA Clearance for Monitoring Patients with Metastatic Colorectal Cancer

Business Wire via NewsEdge Corporation :
Business Editors/Health/Medical Writers
HUNTINGDON VALLEY, Pa.--(BUSINESS WIRE)--November 26, 2007--Immunicon Corporation (NASDAQ-GM:IMMC) announcedtoday that FDA clearance has been received for the CellSearch ™ Circulating Tumor Cell Kit as an aid in the monitoring of patients with metastatic colorectal cancer. The CellSearch test was originally cleared in 2004 for in vitro diagnostic use in patients with metastatic breast cancer. Serial testing for circulating tumor cell (CTC) count should be used in conjunction with other clinical methods for monitoring colorectal or breast cancer. Evaluation of CTC count at any time during the course of disease allows assessment of patient prognosis and is predictive of progression free survival and overall survival. The CellSearch Circulating Tumor Cell Kit, developed by Immunicon, is exclusively marketed by Veridex, LLC, in the cancer field.

read the full article: http://www.devicelink.com/newsedge/

FDA Approves St. Jude's Epic Stented Tissue Valve

St. Jude Medical received FDA approval of its Epic Stented Tissue Valve with Linx AC Technology.
Identical in design to St. Jude’s Biocor Valve, which leads the tissue valve industry in U.S. market share growth, the Epic valve incorporates patented anti-calcification technology to protect against tissue mineralization, or hardening, the company said.
A recently published paper concluded that, over 17 years, the Biocor design reduced tissue fatigue from mechanical stresses, it added.
St. Jude said it will roll out the Epic valve beginning early next year.

Merit Medical Announces 510(k) Notification for Resolve Biliary Catheter

SOUTH JORDAN, Utah, Nov. 26, 2007 (PRIME NEWSWIRE) -- Merit Medical Systems Inc. (Nasdaq:MMSI), a leading manufacturer and marketer of proprietary disposable devices used primarily in cardiology and radiology procedures, announced today that it has received notification from the FDA of 510(k) clearance for the Resolve(tm) Biliary Catheter.
This catheter is placed into the common bile duct, the passageway for bile to flow from the gallbladder and the liver to the small intestine. The catheter drains the bile either internally (inside the intestines) or externally (into a bag outside the body).

read the full article: http://www.primenewswire.com/newsroom/news.html?d=131956

MEDRAD Displays CT Contrast Injection of the Future at RSNA 2007

INDIANOLA, PA -- 11/23/07 -- RSNA -- MEDRAD, INC., makers of the market-leading Stellant® CT Injection System, will display "CT Contrast Injection of the Future" at the Radiological Society of North America (RSNA) exhibition in Chicago, November 25 - 29, 2007. Visitors to the CT Futures exhibit will learn about the leading role of contrast injection in CT imaging and discover patient safety, patient-specific protocol optimization, and workflow and data integration innovations that are in development at MEDRAD.

read the full article: http://www.earthtimes.org/articles/show/news_press_release,229205.shtml

Siemens Introduces Its New Generation of Artis Interventional Imaging Systems

PR Newswire via NewsEdge Corporation :

CHICAGO, Nov. 25 /PRNewswire-FirstCall/ -- Siemens Medical Solutions (www.usa.siemens.com/medical) introduces its next generation of interventional imaging systems that offer breakthrough versatility, enhanced image quality and streamline workflow across an array of clinical environments, from body and neurointerventional radiology suites to operating rooms and hybrid rooms. Siemens is showcasing its new Artis zee(R) family of interventional imaging systems at the 93rd Scientific Assembly and Annual Meeting of the Radiological Society of North America (RSNA) from Nov. 25 to 30 at McCormick Place (Booth #7713, Hall B).

read the full article: http://www.devicelink.com/newsedge/

Review of 2007 legislative and regulatory issues that affect renal care

This year, several newly effective regulations were issued that will have a dramatic impact on the dialysis industry and on hospital-based kidney transplant programs. In addition, if ultimately enacted, legislation first proposed earlier this year will have a dramatic and far-reaching economic effect on the dialysis industry, particularly in regard to reimbursement for dialysis services. It also appears likely that comprehensive regulations will be issued in 2008 that will govern the operation of dialysis centers in the U.S.

read the full article: http://www3.interscience.wiley.com/cgi-bin/fulltext/116844601/PDFSTART?CRETRY=1&SRETRY=0

Doc says med manufacturers using his stent technology

A surgeon considered a leader in cardiac stent technology is taking on Boston Scientific Corp. and Johnson & Johnson for infringement of his patents. Wall Cardiovascular Technologies, the company of Dr. W. Henry Wall in Marshall, filed a complaint for patent infringement against BSC and J&J on Nov. 16. The federal lawsuit was filed in the Marshall Division of the Eastern District of Texas.According to the original complaint, on Dec. 13, 2005, U.S. Patent No. 6,974,475 was duly and legally issued to Dr. W. Henry Wall for an invention titled Angioplasty Stent. All rights to the '475 Patent were assigned to Wall Cardiovascular Technologies LLC in Marshall on Nov. 2, 2007.

read the full article: http://www.setexasrecord.com/news/204310-doc-says-med-manufacturers-using-his-stent-technology

EV Today November 2007 Supplement

Thoracic Aortic Disease: http://www.evtoday.com/PDFarticles/1107/1107_supp.pdf

Endovascular Today - November 2007

Chief Medical Editor's PageBy Takao Ohki, MD, PhD
News
FEATURED TECHNOLOGY:Aggressive DVT Management Strategies and TechniquesFeaturing Mark W. Mewissen, MD; Anthony C. Venbrux, MD; and Peter H. Lin, MD
VESSEL UPDATE: AAAPIVOTAL Trial UpdateBy Daniel G. Clair, MD, and Kenneth Ouriel, MD
CHALLENGING CASESRenal Salvage in a Patient With a Solitary KidneyBy Edward Miner, MD, and Zvonimir Krajcer, MD
TECHNIQUESManagement of Femoral Arterial Access: To Close or Hold Pressure?By Thomas M. Tu, MD, and Jennifer A. Tremmel, MD, SM
COVER STORYTEVAR Access, Delivery, and FixationBy Frank J. Criado, MD
Endovascular Repair of Traumatic Thoracic Aortic InjuriesBy Peter H. Lin, MD; Tam T. Huynh, MD; Joseph S. Coselli, MD; and Kenneth L. Mattox, MD
Future TEVAR DevicesBy W. Anthony Lee, MD
TEVAR for the Ruptured Thoracic AortaBy Lee J. Goldstein, MD; Venkatesh G. Ramaiah, MD; and James F. McKinsey, MD
Hybrid Interventions for Complex Aortic PathologyBy Alan B. Lumsden, MD; Eric K. Peden, MD; Jon-Cecil Walkes, MD; Mahesh Ramchandani, MD; Uttam Tripathy, MD; and Michael J. Reardon, MD
Fenestrated Options for Aortic Arch ApplicationsBy Shin Ishimaru, MD; Satoshi Kawaguchi, MD; and Yoshihiko Yokoi, MD
Pressure Sensors to Monitor Thoracic Stent Graft ProceduresBy Karthik Kasirajan, MD
Type B Aortic DissectionBy Ross Milner, MD

Covidien Acquires Scandius Biomedical Inc.

Biotech Week via NewsEdge Corporation :

2007 NOV 28 - (NewsRx.com) -- Covidien Ltd. (NYSE: COV, BSX: COV), a leading global provider of healthcare products, announced that one of its subsidiaries has acquired Scandius Biomedical Inc., a developer of devices for sports-related surgeries. Financial terms were not disclosed (see also Biomedicine).
Located in Littleton, MA, Scandius Biomedical uses a network of distributors to sell proprietary products for arthroscopic reconstruction of the Anterior Cruciate Ligament (ACL): the Stratis(R) ST Femoral Fixation System and the TriTis(R) Tibial Fixation System. The systems consist of instrumentation and both non-absorbable and bioabsorbable polymer implants.

read the full article: http://www.devicelink.com/newsedge/

Baxter Receives 510(k) Clearance From FDA for V-Link With VitalShield, New Antimicrobial Intravascular Technology

Drug Week via NewsEdge Corporation :

2007 NOV 30 - (NewsRx.com) -- Baxter Healthcare Corporation announced that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its V-Link Luer-activated device (LAD) with VitalShield protective coating. V-Link with VitalShield is the first needleless IV connector containing an antimicrobial coating. This new device has been shown to kill 99.9 percent of specific common pathogens (infection- causing microorganisms) known to cause catheter-related blood stream infections, including the highly treatment-resistant bacteria called methicillin-resistant Staphylococcus aureus, or MRSA. The Centers for Disease Control and Prevention (CDC) recently reported that MRSA infections cause an estimated 18,650 deaths per year in the United States (U.S.), which is more deaths in the U.S. per year than HIV/AIDS (see also Drug Resistance).

read the full article: http://www.devicelink.com/newsedge/

FDA Clears Advanced Test For Monitoring Metastatic Colorectal Cancer

Veridex, LLC announced that the U.S. Food and Drug Administration (FDA) has granted an expanded clearance for the CellSearch™ System to be used as an aid in the monitoring of metastatic colorectal cancer. CellSearch™ is currently approved for monitoring metastatic breast cancer.The CellSearch™ System identifies and counts circulating tumor cells (CTCs) in a blood sample to predict progression-free survival and overall survival in patients with metastatic colorectal or breast cancer, and can do so earlier than the current standard of care. The results of serial testing for CTCs with the CellSearch™ System, in conjunction with other clinical methods for monitoring, can help physicians assess disease progression, thereby guiding more informed care decisions earlier.

read the full article: http://www.medicalnewstoday.com/articles/89671.php

Arterial Vascular Disease Underdiagnosed, Undertreated In Older US Women

ScienceDaily (Nov. 22, 2007) — Though arterial vascular disease is widespread and often deadly among older American women, doctors too often fail to spot and treat it, according to a new report by a team of vascular surgeons from the Columbia University Medical Center and Weill Cornell Medical College campuses of NewYork-Presbyterian Hospital.

"Much of that is due to the fact that for years, cardiovascular research has focused almost exclusively on males, so in many cases we simply don't understand the true prevalence or level of threat women face from vascular disease," says the study co-author, Dr. Ageliki G. Vouyouka, assistant professor of surgery in the Department of Vascular Surgery at Weill Cornell Medical College, and a vascular surgeon at NewYork-Presbyterian Hospital. "Obviously, we need more trials focused on the vulnerability of women to these crippling and even lethal conditions."

read the full article: http://www.sciencedaily.com/releases/2007/11/071121104052.htm

Multicenter registry results suggest a 1% incidence of contrast-induced nephropathy among high-risk

Benephit Renal Infusion Therapy registry shows positive results

Data from a multicenter registry of targeted renal therapy (TRT) in patients at high risk for acute kidney injury—a common complication of hospitalized patients and one that is associated with increased short and long-term mortality—was presented Sunday at the American Society of Nephrology’s Renal Week 2007 by James A. Tumlin, M.D., nephrologist, Clinical Research Division, Southeast Renal Associates, Charlotte, N.C.TRT is the delivery of physician-specified therapeutic agents directly to the kidneys via the renal arteries through the innovative Benephit Infusion Systems from FlowMedica, Inc. TRT may offer significant benefit in direct infusion of therapeutic levels of medications without the side effects that can be encountered with conventional IV delivery.Dr. Tumlin’s presentation, “Intra-Renal Infusion with Fenoldopam Mesylate Reduces Acute Kidney Injury Following Cardiothoracic Surgery or Exposure to Iodinated Contrast Agents: Results from the Be-RITe Registry,” included the analysis of 501 patients enrolled in the Be-RITe Registry. The presentation of the registry results was the first time the data has been presented at the ASN meetings.

read the full article: http://www.nephronline.com/nephnews/index.php?option=com_content&task=view&id=1719&Itemid=1

Endologix Announces the Presentation of Favorable Powerlink System Clinical Data at 2007 VEITH Symposium

IRVINE, Calif.--(BUSINESS WIRE)--Endologix, Inc. (Nasdaq:ELGX) today reported that favorable Powerlink® System clinical data was featured in two presentations on Saturday, November 17 at the 34th Annual VEITH Symposium in New York City. The presentations by Professor Dieter Raithel, M.D., Southern Clinic in Nuremburg, Germany, and Jeffrey Carpenter, M.D., University of Pennsylvania School of Medicine, are available on the Endologix Web site at http://www.endologix.com/health_clinical_presentations.php.

In his presentation “Why is the Endologix Powerlink Endograft with Fixation on the Aortic Bifurcation Best for Most AAAs?,” Professor Raithel reported that the Powerlink’s unique design characteristics make it superior in treating patients with aneurysm anatomy deemed unsuitable for other stent grafts. His conclusion was based on his experience with 1,492 stent graft procedures, including 492 Powerlink System cases over an 8½ year period. He stated that the Powerlink System is a critical component of his armamentarium that allows him to treat more than 90% of all eligible AAA patients with a stent graft.

Full story: Business Wire

Smith & Nephew sells vein business to Boston buyers

British medical devices firm Smith & Nephew PLC has sold its vascular business to a group of Boston-area investors called InaVein LLC.

Smith & Nephew reports the vascular business was part of its Andover-based endoscopy division, which handled the sale to the Boston group. Terms of the deal were not disclosed.
The business acquired by InaVein features products such as a system for minimally invasive removal of varicose veins as well as a catheter-based product designed to remove the veins that cause the formation of varicose veins.

Celsion Corporation Announces Liver Cancer Abstract Accepted for Oral Presentation at 2008 Society of Interventional Radiology Conference

CELSION CORPORATION (AMEX: CLN) today announced that a ThermoDox Phase I liver cancer clinical abstract has been accepted for oral presentation at the 2008 Society of Interventional Radiology (SIR) conference. The SIR is hosting this Annual Scientific Meeting in Washington, DC from March 15th to 20th, 2008. This annual meeting provides advances in research, new devices, world-renowned presenters and training fundamentals for medical professionals in the non-surgical field of interventional radiology.

The oral abstract presentation, titled "Imaging Features in Patients Undergoing Liver RFA Plus Heat Deployed Nanoparticles," will report the unique imaging features suggesting improvement in thermal ablation volume with the addition of ThermoDox. The potential clinical significance of these findings support the randomized study in final planning by Celsion.

read the full text: http://www.ad-hoc-news.de/CorporateNews/en/14274894/Celsion-Corporation-Announces-Liver-Cancer-Abstract-Accepted

Medtronic rises as recall shrugged off

NEW YORK
Shares of medical device maker Medtronic Inc. rose Tuesday after Wall Street shrugged off a 2 percent dip in the company's second-quarter profit on the recall of Sprint Fidelis heart wires.
The stock rose $3.17, or 7 percent, to $48.42 Tuesday. Shares have traded between $44.87 and $57.99 over the past 52 weeks.
Medtronic recalled the leads, which are wires that connect implantable defibrillators to the heart, in October, after discovering they broke more often than expected and contributed to at least five deaths. The stock reached an annual low Monday before rising.
Analysts said the impact from the recall was not as severe as initially forecast and that the worst of the impact is likely behind the company.

read the full article: http://www.businessweek.com/ap/financialnews/D8T1NR6O0.htm

AngioDynamics, Inc.: Good for your wealth

Will Atkinson Nov 21, 2007 1:15pm EST User Rating N/A
AngioDynamics, Inc. (Nasdaq: ANGO) Queensbury, New York http://www.angiodynamics.com/
52-week low / high: $15.68 / $27.08Shares Outstanding: 24.02 millionMarket Capitalization: $474.91 million
Everyone from soccer moms wanting varicose veins erased to aging patients needing their clogged arteries cleared has found solutions from AngioDynamics, Inc. (Nasdaq: ANGO). The 19-year-old company makes a wide variety of medical devices that perform cosmetic procedures and others that play a life-saving role. The 550-employee company makes a laser and drug treatment for varicose veins and also makes devices that help deliver chemotherapy drugs.
Aging baby boomers are helping fuel demand for AngioDynamics’ cosmetic procedure services. In fiscal year 2007, ended June 2, 2007, the company’s revenue grew 43% to $112.2 million, from $78.5 million in fiscal 2006. The firm’s gross margin also rose to 59% during fiscal 2007, from 58% in 2006. Starting in the first quarter, the company changed its fiscal quarters to end on the last day of the calendar month.

read the full article: http://www.smallcapinvestor.com/articles/11212007-angiodynamics_inc_good_for_your_wealth

FDA Clears Advanced Test for Monitoring Metastatic Colorectal Cancer

PR Newswire via NewsEdge Corporation :

Capable of detecting minute numbers of circulating cancer cells in 40 billion blood cells, the CellSearch test can help guide patient care decisions

WARREN, N.J., Nov. 20 /PRNewswire-USNewswire/ -- Veridex, LLC today announced that the U.S. Food and Drug Administration (FDA) has granted an expanded clearance for the CellSearch(TM) System to be used as an aid in the monitoring of metastatic colorectal cancer. CellSearch is currently approved for monitoring metastatic breast cancer.
The CellSearch(TM) System identifies and counts circulating tumor cells (CTCs) in a blood sample to predict progression-free survival and overall survival in patients with metastatic colorectal or breast cancer, and can do so earlier than the current standard of care. The results of serial testing for CTCs with the CellSearch(TM) System, in conjunction with other clinical methods for monitoring, can help physicians assess disease progression, thereby guiding more informed care decisions earlier.

read the full article: http://www.devicelink.com/

MIV Therapeutics to Sell Israeli Subsidiary SagaX

ATLANTA, GA--(HSMN NewsFeed)--Nov 21, 2007 -- MIV Therapeutics, Inc. (OTC BB:MIVT.OB ) (Frankfurt:MIV.F ), a leading developer of next-generation coatings and advanced drug delivery systems for cardiovascular stents and other implantable medical devices, made public that it has entered into a definitive Share Purchase Agreement to sell all of its issued and outstanding shares of SagaX Inc. ("SagaX") in consideration of the repayment of $4.0 million plus future royalties on sales of 8.0%. The payments will be made in increments of $1.0 million upon the achievement of various equity financing parameters which may be met by SagaX over a four-year period from closing.

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Confirma Expands Computer-Aided-Detection (CAD) for MRI to Prostate, Assisting in Improved Cancer Detection

Bellevue Company Expands on Its Success in Breast

MRI BELLEVUE, Wash.--(HSMN NewsFeed)--Confirma®, pioneer and leader in application-specific CAD for MRI, today announced the introduction of CADstream for prostate for improved analysis and reporting of the prostate. The prostate application will offer radiologists comprehensive and clinically valuable tools for improved quality, standardization and efficiency of MRI studies. CADstream for prostate will be presented at the upcoming Radiological Society of North America (RSNA) meeting, the largest medical meeting in the world and the pre-eminent venue for introducing new technologies for radiology (November 25-27, Chicago). At the meeting, the company will also introduce the next generation of CADstream for breast MRI.

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Smiths Medical, Premier Sign 3-Year Contract

ST. PAUL, Minn.--(HSMN NewsFeed)--Smiths Medical, part of the global technology business Smiths Group, announced today that it has been awarded a three-year contract with Premier Purchasing Partners, LP, to offer its PORT-A-CATH® Implantable Access Systems to Premier’s 1,700 hospitals and more than 49,000 other healthcare sites. The agreement runs through October 31, 2010.

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Switzerland Receives First Hyperthermia Cancer Treatment System From BSD Medical

SALT LAKE CITY--(HSMN NewsFeed)--BSD Medical Corp. (AMEX:BSM ) today announced the installation of the first BSD-500 hyperthermia cancer therapy system in Switzerland at the Department of Radiation Oncology of Kantonsspital Aarau. The hospital joins BSD’s growing family of prestigious global customers with the purchase and installation of the new hyperthermia therapy system. The BSD-500 will be used to increase the Department’s cancer therapy technology, particularly in treating advanced and recurrent cancer patients. It delivers hyperthermia through the use of microwave energy, helping to address the limitations of radiation therapy.

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Through-Wave Ultrasound: Effective, Economical and Ideal for Breast Imaging, Biopsy

RICHLAND, Wash., Nov. 20 (HSMN NewsFeed) -- Advanced Imaging Technologies, today announced the ARIA Breast Imaging System (BIS) http://aitimaging.com/index.php?option=com_content &task=view&id=16&Itemid=31, a real-time through-wave ultrasound imaging system that uses the diffractive properties of sound combined with holography (HU) to create highly-detailed, three-dimensional images of breast tissue, is now equipped for image-guided biopsy. The automated system has clinically proven to provide superior views of the breast tissue, especially dense tissue, while delivering better data for enhanced diagnostic decision-making. The system's image-guidance for biopsy will be demonstrated in booth #2179 at the Radiological Society of North America (RSNA) Scientific Sessions November 25-29, 2007 in Chicago.

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MEDIAN Technologies Lesion Management Solutions Set the Trend in Diagnostic Oncology Imaging at RSNA 2007

SOPHIA ANTIPOLIS, France, November 20 (HSMN NewsFeed) -- With the recent FDA approval of LMS-Lung/Track and LMS-Liver, two applications dedicated to the evaluation and follow-up of cancerous or other potentially malignant lesions identified in chest and liver CT images, MEDIAN Technologies succeeds in setting the trend in diagnostic oncology imaging. The company will showcase its complete portfolio of Lesion Management Solutions at the 93rd annual meeting of the Radiological Society of North America (RSNA) in Chicago, hall B, booth #8548.

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Covidien Enters Contrast Imaging Agent Deal With MedAssets Supply Chain Systems - Quick Facts

(RTTNews) - Covidien (COV charts news PowerRating) announced that it has entered into a new deal to supply X-ray contrast imaging agents to customers of MedAssets Supply Chain Systems, a St. Louis-based group purchasing organization. The company noted that the multi-year deal broadens the scope of its Imaging Solutions products available to MedAssets Supply Chain Systems customers nationwide.

The company stated that as per the deal, it would offer a range of products used to aid in the diagnosis of disease including X-ray contrast agents, sodium chloride injection, USP 0.9% in Ultraject prefilled syringes and MD-Gastroview.

read the full article: http://www.tradingmarkets.com/.site/news/BREAKING%20NEWS/838773/

Thoratec Recalls Implantable Ventricular Assist Devices

Thoratec has issued a Class I recall of its Implantable Ventricular Assist Devices (IVADs) with serial numbers 488 and higher that were manufactured and distributed from Oct. 1, 2004, through Oct. 22, 2007.

The instructions for use state that IVADs may be implanted in the pre-peritoneal position or placed in the paracorporeal position, the company said. However, in the paracorporeal position, the pneumatic driveline is external to the patient and may be damaged if the driveline is bent at a sharp angle relative to its junction with the pump housing, which could cause a reduction or interruption of circulatory support.

The affected IVADs were distributed to 87 hospitals throughout the U.S. and other countries, according to Thoratec. The company has received seven reports of damaged drivelines in paracorporeal IVADs, five of which resulted in patient injuries and one in a patient death.

October FDA Reported Adverse Events

Listed by date:

COOK, INC.
ZENITH AAA ILIAC LEG ; ATB ADVANCE PTA DILA ; ZENITH AAA ILIAC LEG ; ZENITH RENU CONVERTE ; ZENITH AAA ILIAC LEG ; ZENITH AAA ILIAC LEG ; FORMULA 418 BILIARY

MEDTRONIC VASCULAR
ANEURX STENT GRAFT W ; ANEURX STENT GRAFT ( ; ANEURX AAADVANTAGE S ; ANEURX AAADVANTAGE S ;

KYPHON, INC.
KYPHX HV-R BONE CEME ; X-STOP IPD SYSTEM

ABBOTT VASCULAR-VASC
RX ACCULINK CAROTID ;STARCLOSE VASCULAR C ; XACT CAROTID STENT S ; RX ACCULINK CAROTID ; RX ACCULINK CAROTID ; RX ACCULINK CAROTID ; RX ACCUNET EMBOLIC P ; RX ACCULINK CAROTID ; PERCLOSE PROGLIDE 6F ; PERCLOSE PROGLIDE 6F ;

BOSTON SCIENTIFIC
TAXUS EXPRESS2 PACLI ; TAXUS EXPRESS2 PACLI ; TAXUS EXPRESS2 PACLI ; TAXUS EXPRESS2 PACLI ; TAXUS EXPRESS2 PACLI ; RIGIFLEX II ACHALASI ; HYDROTHERMABLATOR PR ; TAXUS EXPRESS2 PACLI ; TAXUS EXPRESS2 PACLI ; TAXUS EXPRESS2 PACLI ; EXPRESS2 MONORAIL CO ; TAXUS EXPRESS2 PACLI ; ROTABLATOR GUIDE WIR ; LIBERTE MONORAIL COR ; TAXUS EXPRESS2 PACLI ; TAXUS EXPRESS2 PACLI ; EXPRESS BILIARY LD P ; TAXUS EXPRESS2 PACLI ; LUGE GUIDEWIRE ; TAXUS EXPRESS2 PACLI ; WALLFLEX ENTERAL COL ; TAXUS EXPRESS2 PACLI ; TAXUS EXPRESS2 PACLI ; TAXUS EXPRESS2 PACLI ; TAXUS EXPRESS2 PACLI ; TAXUS EXPRESS2 PACLI ; TAXUS EXPRESS2 PACLI ; WALLSTENT ENDOPROSTH ; RADIAL JAW 4

ST. JUDE MEDICAL
8F ANGIO-SEAL VASCUL ; 6F ANGIO-SEAL VASCUL ; 6F ANGIO-SEAL VASCUL

NXSTAGE MEDICAL, INC
NXSTAGE SYSTEM ONE

W.L. GORE & ASSOCIAT
GORE TAG THORACIC EN ; GORE TAG THORACIC EN ; GORE EXCLUDER AAA EN ; GORE DUALMESH PLUS B

MEDRAD, INC.
MEDRAD CT INJECTOR ; MEDRAD CT INJECTOR

C.R. BARD, INC.
TUBE, GASTROINTESTIN ; TUBE, GASTROINTESTIN

ANGIODYNAMICS, INC.
THERMOPAD

SPECTRANETICS CORP.
SLS II

GUIDANT CARDIAC SURG
GUIDANT 4.5 MM HEART

ARROW INTL., INC.
IAB : 7.5 FR - 40 CC ; IAB : 8 FR - 30 CC F ; CVC KIT: 3-LUMEN 7 F ; UNKNOWN BRAND NAME ; CVC KIT: 3-LUMEN 7 F ; UNKNOWN BRAND NAME ; CVC KIT: 3-LUMEN 7 F ; UNKNOWN BRAND NAME ;

CORDIS NEUROVASCULAR
ENTERPRISE VASCULAR

SMITHS MEDICAL
DELTEC COZMO INSULIN ; COZMO INSULIN PUMP

UROLOGIX, INC.
TARGIS SYSTEM

EV3 INC.
PRIMUS GPS BALLOON E ; PRIMUS GPS BALLOON E

Specialized Health Products Enters Agreement with B.Braun Medical S.A.S. for International Distribution of SafeStep Huber Needle Set

Specialized Health Products Enters Agreement with B.Braun Medical S.A.S. for International Distribution of SafeStep(R) Huber Needle Set

BOUNTIFUL, UtahUT-SPECIALIZED-HEALTH
Specialized Health Products International, Inc. (OTCBB:SHPI), a leading developer and marketer of proprietary safety medical products, today announced that it has entered into an agreement with B.Braun Medical S.A.S. for the exclusive supply and distribution of SafeStep® Huber Needle Set in worldwide markets, excluding the United States and Canada.

Under the terms of the agreement, Specialized Health Products will provide finished goods to B.Braun Medical for marketing under B.Braun?s private label and branded as Surecan® SafeStep®. The agreement is for an initial term of three years and includes minimum purchase requirements for the life of the agreement.

read the full article: http://www.ad-hoc-news.de/CorporateNews/en/14254561/Specialized-Health-Products-Enters-Agreement-with-BBraun

Boston Scientific settles Guidant product claims with $240M

Boston Scientific Corp. reports it has amended an agreement to settle claims related to implanted heart defibrillators, agreeing to pay $240 million to cover claims from 8,550 patients. The agreement increased the $195 million the company agreed to pay to settle 4,000 claims in July. The claims stem from product communications in 2005 and 2006 from Guidant Corp., which Boston Scientific acquired in 2006 for $27 billion, according to the company. Boston Scientific reports the agreement covers all claims related to the product complaints in the United States, including unfiled claims. Jim Tobin, the company's CEO, said in a statement he is "pleased" with the agreement. With 28,600 workers, Boston Scientific reported a 2006 net loss of nearly $3.6 billion on revenue of $7.8 billion.

St. Jude possibly most bruised by Medtronic's ICD lead recall

By AMANDA PEDERSEN Medical Device Daily Staff Writer

If last month’s recall by Medtronic (Minneapolis) of its Sprint Fidelis leads was a “kick in the shins” — as one expert called it at the time — to the implantable cardioverter defibrillation (ICD) market, then St. Jude (St. Paul, Minnesota) may receive the biggest bruise.
Medtronic pulled its Fidelis family of ICD leads — thin wires connecting the defibrillator to the heart — in October because they may break inside the body (Medical Device Daily, Oct. 16, 2007).
Since the recall, St. Jude’s Riata leads have come under heavy scrutiny as rumors quickly began to surface about the devices being next in line for a recall.

read the full article: http://www.devicelink.com/newsedge/

Nexavar First FDA-Approved Drug Therapy for Liver Cancer

Only Systemic Therapy Proven to Significantly Improve Overall Survival in Patients with Liver Cancer

WAYNE, N.J. and EMERYVILLE, Calif., Nov. 19 (HSMN NewsFeed) -- Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX ) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application for Nexavar® (sorafenib) tablets for the treatment of patients with unresectable hepatocellular carcinoma (HCC), or liver cancer. Nexavar, an oral anticancer drug, is the first approved systemic therapy for liver cancer and the only one shown to significantly improve overall survival in patients with the disease. In 2005 Nexavar became the first new treatment in more than a decade for advanced kidney cancer, and is currently approved in more than 60 countries for this indication.

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Boston Scientific Announces Amended Agreement to Settle Product Lawsuits

NATICK, Mass., Nov. 19 (HSMN NewsFeed) -- Boston Scientific Corporation (NYSE: BSX ) today announced that an amended agreement has been reached to settle claims associated with a series of product communications issued by Guidant Corporation in 2005 and 2006. Boston Scientific acquired Guidant last year. This agreement amends a prior agreement Boston Scientific reached in July 2007 to cover additional unanticipated claims.

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Siemens Expands the SOMATOM Definition(TM) Line With World's First Adaptive CT Scanner

A Defining Moment in CT Begins Today with Siemens New Era of Adaptive CT

ScannersMALVERN, Pa., Nov. 19 (HSMN NewsFeed) -- Siemens Medical Solutions (www.usa.siemens.com/medical) has expanded the SOMATOM Definition(TM) family of computed tomography scanners (CT) with the first CT that adapts to patients with the most challenging clinical situations. The SOMATOM Definition family consists of the SOMATOM Definition Dual Source and the new SOMATOM Definition AS*, the world's first Adaptive Scanner. Both will be on display at the 93rd Scientific Assembly and Annual Meeting of the Radiological Society of North America (RSNA) from Nov. 25 to 30 in Chicago (Booth #7713, Hall B).

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The Aethlon Hemopurifier(R) Reverses Immune Suppression in Cancer

SAN DIEGO--(HSMN NewsFeed)--Aethlon Medical, Inc. (OTCBB:AEMD ), a pioneer in developing medical devices to treat infectious disease, announced today that researchers have documented the Aethlon Hemopurifier® is able to remove the immunosuppressive activity normally found in the fluid of cancer patients. Aethlon recently discovered the Hemopurifier® efficiently captures tumor secreted exosomes that inhibit the ability of the immune system to combat cancer. In follow-on studies, led by Dr. Douglas Taylor at the University of Louisville, it has now been demonstrated that the capture of exosomes by the Hemopurifier® does result in reversing immunosuppressive activity. Dr. Taylor is a recognized authority on the causative effects of immune suppression in cancer patients. He is credited with the initial characterization of exosomes and is a leading peer reviewed author on the subject.

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Cook Pharmica Signs Agreement with Inspiration Biopharmaceuticals for the Transfer of its Clinical Manufacturing Process for Lead Hemophilia Compound

BLOOMINGTON, Ind.--(HSMN NewsFeed)--Cook Pharmica, the contract biopharmaceutical manufacturing and development services division of Cook Medical, announced today that it has signed an agreement with Inspiration Biopharmaceuticals, to conduct development work for its lead biologic therapy, an intravenous Factor IX product for patients with hemophilia B. Activities will be performed in Cook Pharmica’s development laboratory within its Bloomington, Ind. facility.

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Confirma to Showcase the Access Breast Coil(R) at RSNA in Chicago

Interventional Components Receive FDA 510(k) Clearance

BELLEVUE, Wash.--(HSMN NewsFeed)--Confirma®, pioneer and leader in application-specific CAD for magnetic resonance imaging (MRI), announced today that the Company will showcase its Access Breast Coil® at the Radiological Society of North America (RSNA) Meeting in Chicago, November 25-30 (Booth 7950, North Hall). With the addition of the Access Breast Coil to its suite of products that includes CADstream® for breast MRI, Confirma continues its vision to provide comprehensive products to imaging centers that improve quality, efficiency and standardization in breast MRI. The Access Breast Coil is designed for high-quality diagnostic imaging, flexible interventional access and optimized patient comfort.

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Smith & Nephew Endoscopy Announces the Sale of its Vascular Business

ANDOVER, Mass., Nov. 19 (HSMN NewsFeed) -- Smith & Nephew's (NYSE: SNN ; LSE: SN ) Endoscopy Division today announced the sale of its vascular business to InaVein LLC, a Boston-area investor group led by Jonathan Donaldson and Patrick Maley, longstanding members of the medical device marketplace. Terms of the sale were not disclosed.

The sale supports Endoscopy's objective to refine its product portfolio as part of Smith & Nephew's overall Earnings Improvement Program, which was announced early this year.The vascular business includes The TRIVEX(TM) System for minimally invasive removal of varicose veins, and the Tumescent Catheter Inversion (TCI) System for the removal of the greater saphenous vein, a procedure which can prevent further varicose vein formation.

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Recent 510(k) Approvals

Smiths Medical: gripper micro needle
C.R. Bard: titanium powerport isp implanted port; powerpicc solo; dorado pta balloon dilatation catheter
Intromed: ptfe peel away microintroducer
Medtronic: guardwire temporary occlusion and aspira; pioneer catheter
Siemens: symbia-e, model 10275879
Cardiovascular Systems: diamondback 360 degree orbital atherecto
Abbott Laboratories: fox sv pta catheter; modification to rx herculink elite bilia
Pfm Medical: t-port hp infusion port
Vascular Solutions: thrombix patch thrombin hemostasis patch; qxt extraction catheter
Micrus Endovascular: micrus courier enzo microcatheter 0.0190
Radius Medical Technologies: radius snare
Ekos: endowave infusion system
Cook: ciaglia blue dolphin (tm) balloon percut
New Star Lasers: cooltouch, model lc215,coollipo
Emcision: habib veseal
Omnisonics: omniwave endovascular system
Arrow: arrow echogenic introducer needle compon
Boston Scientific: ilab ultrasound imaging system, version
Medegen: maxplus tru-swab positive displacement c
St. Jude: brk transseptal needle
Possis: angiojet ultra dvx thrombectomy set, mod

Integra LifeSciences Honored as 2007 Medical Device Manufacturer of the Year by Medical Device & Diagnostic Industry Magazine

PLAINSBORO, N.J., Nov. 14, 2007 (PRIME NEWSWIRE) -- Integra LifeSciences Holdings Corporation (Nasdaq:IART), a world leader in regenerative medicine, announced today that it has been selected by Medical Device & Diagnostic Industry (MD&DI) magazine as a "2007 Medical Device Manufacturer of the Year." Integra was selected for its innovative medical devices, commitment to research, market success, and its impressive quality and regulatory record. The announcement was made in the November issue of MD&DI.

"We are very pleased that MD&DI has recognized Integra's substantial growth and accomplishments," said Integra's President and CEO Stuart Essig. "Integra is dedicated to bringing the best possible medical products to the market and we're committed to quality -- it's at the core of our philosophy and pervades our entire organization. This honor is truly the result of the hard work of our employees, and together we have created a very successful organization that helps millions of patients."

Since Integra's inception in 1989, Integra has grown from a company with one product -- an artificial skin, used in wound and burn care, called Integra(R) Dermal Regeneration Template -- to a company with thousands of medical devices and instruments. Today, Integra is a market leader in neurosurgery and has embarked on a similar course to become a major company in the hand, foot and ankle sector of the orthopedics market.

read the full article: http://money.cnn.com/news/newsfeeds/articles/primenewswire/131408.htm

Secrets of Medical Device Recruiting and Retention Revealed at November SEMDA Meeting

ATLANTA - In the highly competitive medical device industry, finding and keeping great talent is easier said than done. Attendees of November’s Southeastern Medical Device Association (SEMDA) meeting will have the opportunity to learn and ask questions from proven industry experts on best practices in recruiting and keeping top talent.

The event will take place Wednesday, November 28, 2007 in the Trustees Dining Room in Mercer's Cecil B. Day Graduate & Professional Campus at 3001 Mercer University Drive located off I-85 at Chamblee Tucker Road. Networking will begin at 5:30 pm, the presentation will begin at 6:30 pm.

read the full article: http://atlanta.dbusinessnews.com/shownews.php?newsid=141125&type_news=latest

New Anemia Measure Predicts Risk of Death in Dialysis Patients

Newswise — A new indicator of variations in hemoglobin level over time is a strong predictor of the risk of death among patients receiving dialysis for end-stage renal disease (ESRD), reports a study in the December Journal of the American Society of Nephrology.

"Hemoglobin variability—a measure of the stability of levels of hemoglobin among chronic hemodialysis patients—provides a novel way of thinking about and understanding the relationship between anemia and outcomes in ESRD," comments Dr. Harold I. Feldman of University of Pennsylvania School of Medicine, Philadelphia, one of the study authors.

The researchers used data on nearly 35,000 dialysis patients to analyze the effects of hemoglobin variability on the risk of death. They focused on a newly developed metric, termed “Hb-Var,” that measures variability in hemoglobin levels independent of their absolute values and trends over time.

read the full article: http://www.newswise.com/articles/view/535352/?sc=dwhr

Hansen Medical Completes Acquisition Of AorTx

MOUNTAIN VIEW, Calif.--(HSMN NewsFeed)--Hansen Medical, Inc. (Nasdaq:HNSN ) reported today that it has completed its acquisition of AorTx, Inc., an early stage developer of “percutaneous” or catheter-based valve technology. The acquisition will support Hansen Medical leveraging its Sensei™ Robotic Catheter system, which is currently marketed for electrophysiology procedures, into the rapidly developing market for percutaneous heart valve therapy.

The financial terms of the acquisition include closing payments of 140,048 shares of Hansen Medical common stock and approximately $4.5 million in cash and Hansen Medical’s payment or cancellation at closing of approximately $1.0 million of AorTx liabilities. In addition, there are also possible milestone payments that total up to $15 million in Hansen Medical common stock and $15 million in cash upon the achievement of regulatory clearances and revenue and partnering milestones.

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LeMaitre Vascular Launches Next-Generation Stent Graft Delivery System

BURLINGTON, Mass., Nov. 16 (HSMN NewsFeed) -- LeMaitre Vascular, Inc. (Nasdaq: LMAT ) today announced the commercial launch of the TT(TM) Tortuous Tracker Delivery System, the next-generation introducer for LeMaitre Vascular's EndoFit® and UniFit(TM) Aortic Stent Graft product lines. The new delivery system will be sold beginning on Monday, November 19th, in the European Union and other select markets outside of the United States.

The TT system is designed to simplify stent graft implants by requiring reduced deployment force, providing the physician with increased control over placement of the stent graft in the aorta. The TT system offers better flexibility and an improved coating to increase maneuverability through blood vessels and a three-part valve system to minimize blood loss during the medical procedure. The TT system also provides better visualization during the procedure and a more ergonomic design.

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BCC Research Market Data Indicates Cardiovascular Diagnostics, Drug, and Devices Market to Top $192.4 Billion by 2012

Business Wire via NewsEdge Corporation :

WELLESLEY, Mass.--(BUSINESS WIRE)--November 15, 2007--According to a new technical market research report, CARDIOVASCULAR MEDICINE: DIAGNOSTICS, DRUGS AND DEVICES (HLC041B) from BCC Research (www.bccresearch.com), the global market for cardiovascular diagnostics, drugs and devices will be worth $119.8 billion in 2007. This is expected to increase to over $192.4 billion by 2012, a compound average annual growth rate (CAGR) of 9.9%.
The market is broken down into applications of cardiovascular diagnostics, drugs and devices. Of these, cardiovascular drugs is the largest in terms of revenue. Valued at $82.4 billion in 2007, it is expected to reach $121.6 billion by 2012, a CAGR of 8.1%.

read the full article: http://www.devicelink.com/newsedge/

Micrus Endovascular to Divest $3 Million in Non-Core Cardiac and Peripheral Assets to Merit Medical Systems

Health & Medicine Week via NewsEdge Corporation :

2007 NOV 19 - (NewsRx.com) -- Micrus Endovascular Corporation (Nasdaq:MEND) announced that it has entered into a non-binding term sheet to sell certain cardiac and peripheral catheter platform assets and technology for $3 million to Merit Medical Systems, Inc. (Nasdaq:MMSI), a leading manufacturer and marketer of proprietary disposable devices used primarily in cardiology and radiology procedures. The purchase will include the transfer from Micrus to Merit of manufacturing know-how, intellectual property, inventory and technology (see also Angiology).

read the full article: http://www.devicelink.com/newsedge/

Abbott Confirms FDA Advisory Panel to Review XIENCE(TM) V Drug Eluting Stent on November 29

Medical Letter on the CDC & FDA via NewsEdge Corporation :

2007 NOV 25 - (NewsRx.com) -- Abbott (NYSE:ABT) announced that the U.S. Food and Drug Administration (FDA) has confirmed a Circulatory Systems Devices Advisory Panel meeting on Nov. 29, 2007, to review the company's Premarket Approval (PMA) submission for the XIENCE(TM) V Everolimus Eluting Coronary Stent System (see also Heart Attack).
Abbott filed its PMA for XIENCE V with the FDA on June 1, 2007. The company anticipates that it will launch XIENCE V in the U.S. in the first half of 2008, pending FDA approval.

read the full article: http://www.devicelink.com/newsedge/

FDA 510(k)-Cleared TerraQuant(R) Combines World's Fastest Super Pulsed Laser With Infrared, Visible Red Light and Magnetic Field to Speed Pain Relief

Immunotherapy Weekly via NewsEdge Corporation :

2007 NOV 21 - (NewsRx.com) -- Multi Radiance Medical, a leading developer of therapeutic laser devices, announces a breakthrough in technology with TerraQuant(R), a clinically proven, FDA 510(k)-cleared, therapeutic laser device that offers relief to chronic and acute pain sufferers, including Olympians and professional athletes. Combining 25,000 milliwatts of peak power with the world's fastest super pulsed laser, TerraQuant delivers pulses at billionths of a second, producing a high-energy density that is absorbed deep into the tissue, accelerating pain relief. Using exclusive Multi Radiance Technology, TerraQuant safely delivers photons to help heal damaged cells (see also Fibromyalgia).

read the full article: http://www.devicelink.com/