Luminetx Inks Deal with Amerinet

MEMPHIS, Tenn. — Luminetx Corp. announced today it has signed a key three-year vendor contract with one of the countries premier Group Purchasing Organizations (GPO) Amerinet Inc., which represents the Memphis-based company's first group purchasing contract to date.
Through the deal, Amerinet's 24,000-plus member base, of which more than 2,000 are acute care institutions in nature, will have access to custom Amerinet group purchasing discounts as they relate to the VeinViewer by Luminetx(TM), the company's signature product. The vascular imaging system allows physicians, nurses and other health care professionals to clearly see accessible vasculature (or lack thereof) in real time. The device uses a combination of near-infrared light and patented technologies to image vascular structures and project their location directly on the surface of the skin. This provides clinicians with a safe, non-invasive adjunct technology for clinical treatments and procedures including, but not limited to: IV insertions, PICC line insertions, routine venipuncture (blood sampling), blood and plasma donations and treatment for varicose and spider veins.

full article >> http://www.centredaily.com/business/story/300547.html

LeMaitre Vascular Acquires Biomateriali, a Vascular Graft Manufacturer

BURLINGTON, Mass., Dec. 21 (HSMN NewsFeed) -- LeMaitre Vascular, Inc. (Nasdaq: LMAT ), a provider of peripheral vascular devices and implants, yesterday acquired Biomateriali S.r.l., a privately held Italian vascular graft manufacturer, for euro 1.8 million in cash, the assumption of euro 0.8 million in intercompany liabilities, and contingent liabilities of euro 1.0 - euro 1.5 million. The acquisition was structured as a stock purchase.
Key attributes of Biomateriali:-- Biomateriali designs, manufactures, and markets straight and bifurcated polyester arterial prostheses. Polyester vascular grafts are used in a variety of arterial replacement and repair surgeries, predominantly open abdominal aortic aneurysm ("AAA") repair. Biomateriali has been manufacturing these prostheses under the "Albograft" brand for over 10 years.

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Biosphere-DuPont Collaboration May Create Higher-Margin Microspheres

BioSphere Medical, which has an FDA approved method to treat symptomatic uterine fibroids using microsphere technology, has signed an agreement with DuPont Applied BioSciences to evaluate potential peripheral vascular and embolotherapy research, development, and manufacturing projects.

The agreement establishes a “non-binding framework” for the parties to consider and evaluate potential projects that target and deliver leading edge solutions in embolotherapy.

full article >> http://www.onemedplace.com/blog/archives/500

Merit Medical Announces 510(k) Notification For New Sea Dragon Torque Device

SOUTH JORDAN, Utah, Dec 20, 2007 (PrimeNewswire via COMTEX) -- 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 its new Sea Dragon torque device.

The Sea Dragon torque device is used specifically with hydrophilic guide wires. It was recently released in Europe and is being well received by physicians there.

press release >> http://www.foxbusiness.com/markets/industries/health-care/article/merit-medical-announces-510k-notification-new-sea-dragon-torque-device_415426_10.html

AngioDynamics Issues Radiofrequency Ablation Statement

AngioDynamics Issues Radiofrequency Ablation Statement

QUEENSBURY, N.Y.--(BUSINESS WIRE)--AngioDynamics (NASDAQ:ANGO), a leading provider of innovative medical devices used by interventional radiologists and surgeons for the minimally invasive treatment of cancer and peripheral vascular disease, today commented on the clinical studies on which the FDA based its December 11, 2007 Public Health Notification regarding the deaths associated with the use of radio frequency ablation of lung tumors. No AngioDynamics’ RITA radio frequency ablation (RF) probes were used in these studies.

AngioDynamics has conducted a 106 patient clinical trial, RAPTURE, involving the use of its RF technology to treat lung malignancies. The trial included patients from Europe, Australia and the United States. There were no deaths within 30 days of treatment. Further, the Company knows of no reported deaths in published studies in which AngioDynamics RF probes were used to treat a variety of lung tumors. The Company expects the RAPTURE clinical trial results to be published in the first half of 2008.

press release >> http://www.businesswire.com/portal/site/google/index.jsp?ndmViewId=news_view&newsId=20071219005759&newsLang=e

PLC Medical Systems Names Lead Investigators for Pivotal Trial to Evaluate RenalGuard System(TM) and RenalGuard Therapy(TM)

Trial designed to evaluate effectiveness of RenalGuard(TM) in preventing Contrast -Induced Nephropathy
FRANKLIN, Mass., Dec. 19 /PRNewswire-FirstCall/ -- PLC Systems Inc. , a company focused on innovative cardiac and vascular medical device-based technologies, announced today that it has named two lead investigators for the upcoming pivotal trial of its RenalGuard Therapy(TM). The lead investigators are Charles Davidson, MD, Professor of Medicine, Northwestern University Medical School and Richard J. Solomon, MD, Professor of Medicine, University of Vermont College of Medicine. The trial is designed as a multi-center, prospective, randomized controlled trial to evaluate the effect of RenalGuard(TM) in the prevention of Contrast-Induced Nephropathy (CIN) during cardiovascular and peripheral imaging procedures performed in a catheterization lab. PLC intends to begin enrollment in the RenalGuard Pivotal Trial in early 2008, following receipt of the necessary approval from the U.S. Food & Drug Administration.

full article >> http://money.cnn.com/news/newsfeeds/articles/prnewswire/NEW03119122007-1.htm

ev3 Introduces Two New Enhanced Offerings For the Treatment of Peripheral Artery Disease

The SilverHawk® LS-M and MS-M with proprietary MEC™ Technology increases tissue collection capacity, representing an important advancement in Above the Knee treatment of Peripheral Artery Disease
PLYMOUTH, Minn.--(BUSINESS WIRE)--ev3 Inc. (NASDAQ:EVVV), today announced the U.S. launch of the company’s most recent additions to the SilverHawk family of products: the SilverHawk® LS-M and MS-M. These devices are among the latest in plaque excision technology and are designed to treat lesions in arteries above the knee for patients suffering from peripheral artery disease (PAD).
The SilverHawk® LS-M and MS-M include MEC™ (Micro Efficient Compression) Technology, a novel advancement which features precision laser-drilled vent holes in the tip of the catheter. These micro vent holes release fluid pressure, providing more space for the collection of tissue in the tip of the device. This technology has the potential to reduce overall procedure time by enabling physicians to increase tissue collection during plaque removal procedures in large vessels above the knee. In vitro bench test results performed by the company have demonstrated up to a 30 percent increase in tissue capture per insertion compared to the previous device.
press release >> http://www.businesswire.com/portal/site/google/index.jsp?ndmViewId=news_view&newsId=20071218006190&newsLang=en

Ambulatory Services of America Acquires Innovative Dialysis Systems and Related Joint Ventures

NASHVILLE, Tenn., Dec. 18 /PRNewswire/ -- Ambulatory Services of America, Inc. (ASA) announced today that it has completed an acquisition of the assets of Innovative Dialysis Systems, Inc. (IDS) and interests in joint ventures that own and operate 35 dialysis programs in California, Ohio, Oregon, Wyoming and Guam. IDS, owned by Allen Fulmer and Jerry Green, has provided management services to the acquired dialysis programs prior to the transactions. In addition to the 35 programs in which ASA has acquired an interest, it will manage two other dialysis facilities that were previously managed by IDS. ASA did not disclose the terms of the transactions.

full article >> http://www.earthtimes.org/articles/show/news_press_release,244619.shtml

Microfabrica Introduces Set of Miniature 'Building Blocks' for Minimally-Invasive Medical Devices

1-mm turbine, miniaturized 'car jack,' and micro-chainmail demonstrate the company's ultra-precision EFAB manufacturing technology
VAN NUYS, Calif., Dec. 18, 2007 -- Microfabrica Inc. will introduce at Medical Design & Manufacturing West a set of highly-miniaturized 'building blocks' which designers of minimally-invasive medical devices can use to develop innovative new products. Water-powered turbines just over 1 mm in diameter which spin at 120,000 revolutions per minute, millimeter-scale 'car jack'-like expanders, ultra-flexible micro-chainmail metal fabric, micro-needles, miniature ratchets, hinges, slides, and springs, and multi-lumen metal shapes are among the building blocks to be featured. Enabled by the company's unique EFAB manufacturing technology, these building blocks - and devices based on them - will be on display in Booth 466, Hall E, Anaheim Convention Center, Anaheim, CA, January 29-31, 2008.

full article >> http://www.ereleases.com/pr/20071218003.html

BioSphere Medical Receives CE Mark Approval for Transarterial Chemoembolization Using HepaSphere™ Microspheres

ROCKLAND, Mass.--(BUSINESS WIRE)--BioSphere Medical, Inc. (NASDAQ: BSMD) (“BioSphere”), a medical device company that has pioneered the use of bioengineered microspheres to treat uterine fibroids, hypervascularized tumors, and vascular malformations by a minimally invasive, image-guided medical procedure called embolotherapy, today announced that it has received CE Mark approval for Transarterial Chemoembolization (TACE) of Hepatocellular Carcinoma (HCC) using HepaSphere™ Microspheres (HepaSphere) and Doxorubicin. As a condition of the CE Mark approval, BioSphere will conduct a 100-patient, post-market registry study in 10-15 European centers. CE Mark approval denotes conformity with European standards for safety and allows certified devices to be placed in the market in European Union countries.

press release >> http://www.businesswire.com/portal/site/google/index.jsp?ndmViewId=news_view&newsId=20071218005648&newsLang=en

FlowCardia Launches Peripheral CROSSER Catheter Portfolio In US

Sunnyvale, CA - FlowCardia, Inc., a medical device company developing a portfolio of endovascular devices for the treatment of coronary and peripheral chronic total occlusions (CTOs), announced FDA 510(k) clearance and immediate U.S. launch of the CROSSER 14P, CROSSER 14S and CROSSER 18 CTO Recanalization Catheters.
The three peripheral CROSSER Catheters are endovascular tools used by interventional radiologists, vascular surgeons and interventional cardiologists to cross CTOs to help restore blood flow to the lower legs. The CROSSER is a rapid exchange catheter delivered over standard .014" and .018" guidewires that utilizes high frequency vibration to cross CTOs allowing for subsequent debulking, balloon angioplasty and stent placement. The peripheral CROSSER Catheters were studied in the FlowCardia PATRIOT Trial.

full article >> http://www.medicaldesignonline.com/content/news/article.asp?docid=%7B53E6B130-8A54-4C63-AB31-059A4C2A6828%7D&VNETCOOKIE=NO

Medtronic Starts First Human Study of Endurant™ Stent Graft System for Treatment of Abdominal Aortic Aneurysm

MINNEAPOLIS – Dec. 17, 2007 – Marking a major step toward expanding minimally invasive endovascular therapies, Medtronic, Inc. (NYSE: MDT), today announced the start of the first human study of its Endurant Stent Graft System, an investigational treatment for abdominal aortic aneurysm (AAA). The study supports Medtronic’s goal of providing physicians with a greater variety of solutions for treating patients with AAA – a dangerous bulge or weakness in the body’s main artery that can rupture with fatal consequences if left untreated. The company’s AAA stent graft portfolio currently includes the AneuRx AAAdvantage® platform in the United States and the Talent™ AAA platform outside the United States. The Endurant Stent Graft System’s highly flexible features and lower delivery profile are designed to improve conformability and trackability in tortuous aneurysmal anatomies.

full article >> http://pressmediawire.com/article.cfm?articleID=4301

BioForm Medical shares soar

NEW YORK, Dec 18, 2007 (Thomson Financial via COMTEX) -- BFRM charts news PowerRating -- Shares of BioForm Medical Inc. skyrocketed Monday after CIBC World Markets initiated coverage of the company with a sector outperformer rating and a $12 price range because of the company's anticipated success with new wrinkle-filler product Radiesse.
The shares rose 31.2% to $7.61.
BioForm also has in its pipeline a superficial treatment for varicose veins, Aethoxysklerol, which should get approval from the Food and Drug Administration before the end of 2009, CIBC said.

Angiotech Submits 510(K) To FDA For Its Innovative 5-FU CVC

VANCOUVER, Dec. 17 (HSMN NewsFeed) - Angiotech Pharmaceuticals, Inc. (NASDAQ: ANPI, TSX: ANP), a global specialty pharmaceutical and medical device company, today announced that it has submitted a 510(k) application to the U.S. Food and Drug Administration (FDA) for its innovative, anti-infective 5-Fluorouracil-coated (5-FU) Central Venous Catheter (CVC).
"We are pleased to complete the submission of a 510(k) application to the FDA for our 5-FU CVC, as we believe this represents another important step towards commercializing this product line and developing our 5-FU anti-infective platform," said Dr. William Hunter, President and CEO of Angiotech.Pending the receipt of all necessary regulatory approvals, Angiotech anticipates launching the commercial 5-FU CVC product line in 2008.

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Devax, Inc. Calls Off IPO

Medical device company Devax, Inc on Thursday filed to withdraw plans for an initial public offering, stating that such a move was "no longer in its best interests." Devax originally filed for an IPO in May of 2007, saying in a filing with the SEC that it is looking to raise up to $85M in an IPO on the Nasdaq Global Market.
Devax, originally founded in 1999 to develop a bare metal stent, is now developing the AXXESS Plus, designed specifically for deviating vessels. In 2005, the AXXESS Plus Stent was the first to show clinical results with a drug eluting stent designed specifically for bifurcation lesions.

AMAG Pharmaceuticals, Inc. Announces Presentation of Positive Results from Phase III Studies of Feru

AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG), a biopharmaceutical company that utilizes its proprietary nanoparticle technology for the development and commercialization of therapeutic iron compounds to treat anemia, as well as novel imaging agents to aid in the diagnosis of cancer and cardiovascular disease, today announced positive results from pooled data from three open-label, multicenter, randomized Phase III trials of ferumoxytol as an intravenous iron replacement therapeutic. The data is being presented today at approximately 6:00 pm ET as a poster at the 49th American Society of Hematology Annual Meeting and Exposition in Atlanta, Georgia. The poster is available on the Company’s web site at www.amagpharma.com.
The poster, “Treatment of Iron-Deficiency Anemia with IV Ferumoxytol in CKD Patients: Efficacy Compared with Oral Iron across Different Age Groups” presents results from 885 dialysis dependent and non-dialysis dependent patients with chronic kidney disease (CKD). Patients received either two doses of 510 mg of intravenous (IV) ferumoxytol within one week or 200 mg of oral iron daily for three weeks and were followed for 35 days. The pooled data demonstrated a statistically significant achievement of the primary endpoint in patients treated with ferumoxytol compared to those treated with oral iron.

full article >> http://www.pr-usa.net/index.php?option=com_content&task=view&id=51212&Itemid=9

AngioTech To Conduct Clinical Trials for VaxSys Vascular Wrap

Vascular access is a necessary procedure for patients with End Stage Renal Disease (ESRD) who will undergo hemodialysis. However, it is estimated that up to 50% of vascular accesses with grafts require repair within one year resulting in significant inconvenience and cost to the patient. Fortunately, new treatment options are being developed to make a vascular access last longer, but your help is needed.
Doctors are now conducting an investigational medical research study evaluating the effectiveness of an investigational product called VaxSys Vascular Wrap™ (also called "Vascular Wrap™). When used in conjunction with a vascular graft to create a vascular access for hemodialysis, it is believed that VaxSys Vascular Wrap™ may aid in making the vascular access last longer before repair is necessary by a physician.

information on the study >> http://www.vascularwraptrial.com/

New Statement on Safety of MRI With CV Devices

The American Heart Association has published a scientific statement on the safety of magnetic resonance imaging (MRI) in patients with cardiovascular devices, which has also been endorsed by the American College of Cardiology, the North American Society for Cardiac Imaging, and the Society for Cardiovascular Magnetic Resonance [1]. The document states that for most devices, if there is a good clinical indication for an MRI scan, then the benefits probably outweigh the risks. Lead author Dr Glenn N Levine (Baylor College of Medicine, Houston, TX) told heartwire: "This is the first document that specifically addresses these issues." He explained that, over the years, decisions have been made about when it is safe to do an MRI scan with a particular device, but these have not been based for the most part on any good evidence. "When coronary stents first came out, for example, it was decided that you had to wait a minimum of six weeks before doing an MRI scan, but that was not based on any firm data. And there are still people out there who won't do an MRI ever in a patient with a stent, and that is absurd. We wanted to make recommendations that are in line with actual data and expert opinion."

full article >> http://www.abkhazia.com/content/view/1087/74/

Hatch Medical and Phase One Medical Sign Brokerage Agreement

2007 DEC 20 - (NewsRx.com) -- Hatch Medical, L.L.C., a medical device incubator and technology brokerage firm and Phase One Medical, L.L.C., a medical device research and development company announced that they have recently entered into an agreement for Hatch Medical to broker Phase One Medical's patented medical device anchoring technology platforms, Fusion(TM) and Tissue Clip(TM) (see also Thrombosis).
The medical device anchoring platforms utilize shape memory alloy's and proprietary design elements which can be integrated into implantable medical devices improving fixation and security of the implant. Phase One's unique anchoring systems provide bi-directional migration resistance and are not dependant on radial force for fixation unlike hooks and barbs which are used in many implanted devices today. The company anticipates application of the technology to any implantable medical device relying on fixation to prevent migration such as AAA stent grafts, septal defect and PFO repair products and embolic devices.
Phase One Medical is initially utilizing both technology platforms in development of two highly differentiated removable vena cava filter systems for the prevention of Pulmonary Embolism (PE) resulting from Deep Vein Thrombosis (DVT). Both systems are safely and easily deployed using jugular and femoral access, are non-tilting and are easily removed when clinically warranted. Both filters will have the capability to treat large vena cava's in excess of 35mm. For physicians who prefer wire guidance, the Tissue Clip(TM) system will utilize a unique over-the-wire delivery system featuring a .035" centering guidewire.
More than 600,000 people develop Deep Venous Thrombosis (DVT) annually with the most serious complication of DVT being Pulmonary Embolism (PE). PE is the third leading cause of acute cardiovascular death in the U.S. resulting in up to 200,000 deaths each year.

BioForm Announces Financial Results for Quarter Ended September 30, 2007, First Quarter of Fiscal 2008

SAN MATEO, Calif., Dec. 13 /PRNewswire-FirstCall/ -- BioForm Medical, Inc. today announced its financial results for the quarter ended September 30, 2007, which is the Company's first quarter of fiscal year 2008. Net sales were $15.2 million for the quarter ended September 30, 2007 as compared to $7.8 million for the quarter ended September 30, 2006, an increase of $7.4 million or 95.1%. The net loss was $3.4 million for the quarter ended September 30, 2007 as compared to $2.3 million for the quarter ended September 30, 2006.

BioForm Medical, Inc. is a medical aesthetics company headquartered in San Mateo, California. BioForm Medical is dedicated to bringing doctors and their patients safe and effective products for use in the dermatology, plastic surgery and ENT markets. BioForm Medical's products include Radiesse(R) dermal filler for use in facial aesthetics and vocal fold insufficiency, and Coaptite(R) injectable implant for treating female stress urinary incontinence which is marketed through a partnership with Boston Scientific Corporation. BioForm Medical has licensed U.S. marketing rights to Aethoxysklerol(R) sclerotherapy agent, which is the leading worldwide sclerotherapy agent and is currently being evaluated in a Phase III clinical trial. BioForm Medical has also licensed BioGlue(R) surgical adhesive product for plastic surgery applications, which is being developed in a partnership with CryoLife, Inc

full article >> http://money.cnn.com/news/newsfeeds/articles/prnewswire/AQTH05913122007-1.htm

Boston Scientific Agrees To Sell Fluid Management and Venous Access Businesses to Avista Capital Partners for $425 Million

NATICK, Mass. and NEW YORK, Dec. 13 /PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE: BSX) and Avista Capital Partners, a leading private equity firm, today jointly announced the signing of a definitive agreement under which Avista will acquire from Boston Scientific its Fluid Management and Venous Access businesses for $425 million in cash. The transaction is expected to close in the first quarter of 2008, subject to regulatory approvals and customary conditions. Boston Scientific previously announced its intent to sell these businesses as part of its plan to divest non-strategic assets.
Avista said that upon close of the transaction, the combined Fluid Management/Venous Access business will operate as an independent company under a new name. Ron Sparks, an Avista healthcare industry advisor, will become Chairman and Chief Executive Officer of the new company. Dave McClellan, President of Boston Scientific's Oncology business, will become President of the new company.
The Fluid Management franchise, formerly North American Medical Instruments Corporation (NAMIC), produces a range of products used to manage fluid and measure pressure during angiography and angioplasty procedures. The Fluid Management franchise employs approximately 750 people in its Glens Falls, NY manufacturing facility.

full article >> http://www.globeinvestor.com/servlet/story/PRNEWS.20071213.NETH099/GIStory/

North American Scientific Announces Agreement for Private Placement of Common Stock

CHATSWORTH, Calif.--(BUSINESS WIRE)--North American Scientific, Inc. (Nasdaq: NASI) today announced that on December 12, 2007, North American Scientific, Inc. (the “Company”) entered into a Securities Purchase Agreement with Three Arch Partners IV, L.P. and affiliated funds (“Three Arch Partners”), SF Capital Partners Ltd. (“SF Capital”) and CHL Medical Partners III, L.P. and an affiliated fund (“CHL,” and together with Three Arch Partners and SF Capital, the “Investors”) providing for the private placement (the “Private Placement”) of 63,008,140 shares (the “Shares”) of common stock of the Company, par value $0.01 per share (the “Common Stock”), and warrants to purchase 3,150,407 shares of Common Stock (the “Warrants,” and, together with the Shares, the “Securities”) for a total purchase price of $15.5 million.
North American Scientific is a leader in radiation therapy in the fight against cancer. Its innovative products provide physicians with tools for the treatment of various types of cancers. They include Prospera® brachytherapy seeds and SurTRAK™ needles and strands used primarily in the treatment of prostate cancer. In addition, the Company has been gaining clinical experience with its first generation ClearPath™ multi-channel catheter breast brachytherapy devices in 2007, and intends to launch the second generation devices in 2008. They are the only such devices approved for both high dose and continuous release, or low dose, radiation treatments. The devices are designed to provide flexible, precise dose conformance and an innovative delivery system that is intended to offer the more advanced form of brachytherapy for the treatment of breast cancer. Please visit www.nasmedical.com for more information.

full press release >> http://www.businesswire.com/portal/site/google/index.jsp?ndmViewId=news_view&newsId=20071213006028&newsLang=en

Medicare Changes for Kidney Patients Could be Ahead

The Association of Minority Nephrologists and the National Minority Quality Forum have released a report detailing changes that are currently under consideration from the current U.S. Congress. Lawmakers are discussing altering the current way that Medicare pays for patient care under the End Stage Renal Disease (ESRD) program. Under the status quo program Medicare pays 80 percent of medical costs for an estimated 485,000 ESRD patients. The total payout from Medicare for dialysis, transplants, patient care on both an inpatient and outpatient basis for the ESRD patients is estimated to be around $20 billion. Presently, Medicare reimburses dialysis units at a 'composite rate' that they government sets to cover cost of related supplies and equipment. These facilities then receive a separate payment from Medicare to cover the costs of injectable drugs and diagnostic tests. Congress is considering action to have these two payments grouped together in a new government specified 'bundled rate' for ESRD program participants. The current congress is not the first to consider such a program, starting in the 1990's previous legislatures had researched this cost saving option. However, the research showed that bundling the costs had the possibility of keeping beneficiaries from getting needed medical therapies.

full article >> http://www.associatedcontent.com/article/478255/medicare_changes_for_kidney_patients.html

VeinViewer by Luminetx™ Receives Key Quality and European Certifications

MEMPHIS, Tenn.--(BUSINESS WIRE)--Memphis-based Luminetx Corporation today announced its premier product, VeinViewer by Luminetx™, has received EC and ISO 13485:2003 certifications – thus allowing shipment to European countries and continuing the expansion of the Luminetx global strategy.
The VeinViewer – a vascular imaging system – allows physicians, nurses and other health care professionals to clearly see accessible vasculature (or lack thereof) in real time. The device uses a combination of near-infrared light and patented technologies to image vascular structures and project their location directly on the surface of the skin. This provides clinicians with a safe, non-invasive adjunct technology for clinical treatments and procedures including, but not limited to: IV insertions, PICC line insertions, routine venipuncture (blood sampling), blood and plasma donations and treatment for varicose and spider veins.

full press release >> http://www.businesswire.com/portal/site/google/index.jsp?ndmViewId=news_view&newsId=20071213005152&newsLang=en

PhotoMedex to Supply Lasers Exclusively to AngioDynamics

MONTGOMERYVILLE, Pa.--(BUSINESS WIRE)--PhotoMedex, Inc. (Nasdaq:PHMD) announced today that it will supply private-label diode laser systems exclusively to AngioDynamics, Inc. (Nasdaq: ANGO) to sell and market for peripheral vascular treatments.
In September 2007 AngioDynamics and PhotoMedex entered into a three-year OEM agreement under which PhotoMedex manufactures for AngioDynamics, on a non-exclusive basis, a private-label, 980-nanometer diode laser system. The system is designed for use with AngioDynamics’ NeverTouch™ VenaCure® patented endovenous therapy for treatment of varicose veins. The OEM agreement provides for PhotoMedex to supply this laser on an exclusive basis to AngioDynamics, should AngioDynamics meet certain purchase requirements. With the recent receipt from AngioDynamics of a purchase order that exceeds the minimum purchase requirement for delivery of lasers over the first contract year, PhotoMedex will now provide this laser exclusively to AngioDynamics for worldwide sale in the peripheral vascular treatment field.
Jeffrey O’Donnell, PhotoMedex’ President and Chief Executive Officer, stated, “PhotoMedex has excellent laser development and manufacturing capability that has translated into an OEM agreement that now is exclusive for this 980-nanometer diode laser system for the treatment of vascular diseases and disorders, including varicose veins. Our high standards for quality and reliability were key in attracting AngioDynamics to our diode laser technology. We look forward to a long-term, mutually beneficial relationship.”

full press release >> http://www.businesswire.com/portal/site/google/index.jsp?ndmViewId=news_view&newsId=20071213005479&newsLang=en

Deaths Reported After Radio-Frequency Ablation of Lung Tumors

The FDA issued a notice Dec. 11 informing physicians of deaths associated with the use of radio-frequency (RF) devices during lung tumor ablation. Similar reports have appeared in the literature.
Patient selection, subsequent treatment and technical use of the RF ablation device, including placement and operation, may have contributed to the fatalities, the agency said.
The FDA has cleared many RF devices for general ablation of soft tissue by thermal coagulation necrosis. These devices also have been cleared for certain indications; however, they have not been cleared specifically for lung tumor ablation.
Manufacturers of ablation devices cannot legally market them for use with lung tumors because clinical data establishing their safety and effectiveness for this purpose have not been submitted to the agency. This includes promoting their safety and effectiveness in training programs.

C. R. Bard (BCR) Wins $185M In Patent Infringement Case

C. R. Bard (NYSE: BCR) today announced that a U.S. District Court jury in Arizona decided that certain of W. L. Gore & Associates Inc.'s ePTFE vascular grafts and stent-grafts willfully infringe on Bard's patent number 6,436,135. The jury found that the validity of Bard's claim against W. L. Gore was legitimate and would award $185 million to Bard in past damages. As the trial goes on, the court is currently assessing Gore's counter that Bard's patent is unenforceable due to inequitable content.After the jury's final decision, Bard expects Gore to file for post-trial motions with the court in order to attempt to take the case to the Court of Appeals for the Federal Circuit.

REVA Medical Raises $42 Million

REVA Medical Inc., a San Diego-based developer of bioresorbable stents to treat arterial disease, has raised $42 million in new private equity funding. Cerberus Capital Management and Brookside Capital co-led the round, and were joined by Pequot Capital Management, Medronic and return backers Domain Partners and Group Outcome LLC.

Prior backer Boston Scientific will maintain its equity position, and also holds an exclusive option for global distribution of REVA's resorbable coronary and peripheral stent products. www.teamreva.com

W. L. GORE & ASSOCIATES ANNOUNCES SUMMARY OF GORE PROPATEN VASCULAR GRAFT STUDY DATA PRESENTED AT 34TH ANNUAL VEITHSYMPOSIUM™

Multi-year, multi-site data adds to the growing body of evidence for the GORE PROPATEN Vascular Graft
W. L. Gore & Associates (Gore) announced that interim results from multi-year, multi-center studies using the GORE PROPATEN Vascular Graft were presented recently at the 34th Annual VEITHsymposium™ in New York. The GORE PROPATEN Device is the first device with an ePTFE-heparin combination that is designed to reduce thrombosis (clotting), a common cause of graft failure. The average one-year primary patency from all the reported literature on the GORE PROPATEN Vascular Graft in below-knee bypasses has been reported to be 80 percent.
On the one-year anniversary of the commercial launch of the GORE PROPATEN Vascular Graft in the United States, several presentations at this year’s VEITHsymposium add to the growing body of evidence for the use of this graft in lower-limb and dialysis access applications.

full press release >> http://www.businesswire.com/portal/site/google/index.jsp?ndmViewId=news_view&newsId=20071211005789&newsLang=en

FlowCardia, Inc. Launches Peripheral CROSSER(R) Catheter Portfolio in the US

SUNNYVALE, Calif., Dec. 11 /PRNewswire/ -- FlowCardia, Inc., a medical device company developing a portfolio of endovascular devices for the treatment of coronary and peripheral chronic total occlusions (CTOs), announced FDA 510(k) clearance and immediate U.S. launch of the CROSSER 14P, CROSSER 14S and CROSSER 18 CTO Recanalization Catheters.
The three peripheral CROSSER Catheters are endovascular tools used by interventional radiologists, vascular surgeons and interventional cardiologists to cross CTOs to help restore blood flow to the lower legs. The CROSSER is a rapid exchange catheter delivered over standard .014" and .018" guidewires that utilizes high frequency vibration to cross CTOs allowing for subsequent debulking, balloon angioplasty and stent placement. The peripheral CROSSER Catheters were studied in the FlowCardia PATRIOT Trial.

read the full article >> http://www.earthtimes.org/articles/show/news_press_release,240199.shtml

YMed, Inc. Successfully Completes First Clinical Cases With Innovative VascuTraK(TM) II PTA Dilatation Catheter

SAN DIEGO, Dec. 10 (HSMN NewsFeed) -- YMed, Inc. announced today that it has successfully completed its first U.S. cases with its proprietary VascuTraK(TM) II PTA Dilatation Catheter. The VascuTraK(TM) II PTA Catheter is a unique 5F compatible, single operator rapid exchange system.
YMed's VascuTraK(TM) II catheter is designed and indicated for vascular intervention of a wide range of peripheral arteries including the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

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Recap: November 2007 Adverse Events Reported To FDA

The following are the listed adverse events on the FDA website for the month of November and are listed according to date reported. Click on the product description link for each device to view the FDA report.

St. Jude Medical: 6F ANGIO-SEAL VASCUL ; 6F ANGIO-SEAL VASCUL ; ANGIO-SEAL DEVICE UN ; 6F ANGIO-SEAL VASCUL ; ANGIO-SEAL DEVICE ; 6F ANGIO-SEAL VASCUL

Medtronic Vascular: MEDTRONIC ANEURX BIF ; ANEURX UNK ; MEDTRONIC ANEURX BIF ; ANEURX AAADVANTAGE S ; ANEURX STENT GRAFT ( ; ANEURX STENT GRAFT W ; SYNCHROMED EL ; ANEURX AAADVANTAGE S

Boston Scientific: ROTALINK PLUS ; TITANIUM GREENFIELD ; ROTABLATOR ; ROTALINK PLUS; TAXUS EXPRESS2 PACLI ; WALLGRAFT TRACHEOBRO ; WALLGRAFT TRACHEOBRO ; ROTABLATOR GUIDE WIR ; EXPRESS BILIARY LD P ; CAROTID WALLSTENT MO ; WALLSTENT-UNI ENDOPR ; WALLSTENT-UNI ENDOPR ; .035" BACKUP MEIER S ; TAXUS EXPRESS2 PACLI ; TAXUS EXPRESS2 PACLI ; LIBERTE' MONORAIL ST ; EXPRESS2 MONORAIL CO ; TAXUS EXPRESS2 PACLI ; TAXUS EXPRESS2 PACLI ; TAXUS EXPRESS2 PACLI ; TAXUS EXPRESS2 PACLI ; TAXUS EXPRESS2 PACLI ; TAXUS EXPRESS PACLIT ; TAXUS EXPRESS2 PACLI ; TAXUS EXPRESS2 PACLI ; TAXUS EXPRESS2 PACLI ; MAVERICK BALLOON CAT ; IQ WIRE ; PT WIRE ; TAXUS EXPRESS2 PACLI ; TAXUS EXPRESS2 PACLI

Becton Dickinson: BD VISITEC

C.R. Bard: BARD WOUND SUCTION E

Bard Peripheral: G2 FILTER SYSTEM, FE ; RECOVERY FILTER SYST

Abbott Vascular: XACT CAROTID STENT S ; STARCLOSE VASCULAR C ; XACT CAROTID STENT S ; RX ACCULINK CAROTID ; RX ACCULINK CAROTID

W.L. Gore: GORE EXCLUDER AAA EN ; GORE PROPATEN VASCUL ; GORE PROPATEN VASCUL ; GORE EXCLUDER AAA EN ; GORE EXCLUDER AAA EN ; GORE TAG THORACIC EN ; GORE PROPATEN VASCUL ; GORE PROPATEN VASCUL ; GORE EXCLUDER AAA EN ; GORE EXCLUDER BIFURC ; GORE INTRODUCER SHEA ; GORE PROPATEN VASCUL ; GORE EXCLUDER AAA EN ; GORE PROPATEN VASCUL ; GORE PROPATEN VASCUL ; GORE PROPATEN VASCUL ; GORE EXCLUDER AAA EN ; GORE EXCLUDER AAA EN

Cook: ZENITH RENU CONVERTE ; ZENITH RENU CONVERTE ; ZENITH AAA MAIN BODY ; ZENITH RENU CONVERTE ; ZENITH FLEX AAA ENDO ; ZENITH FLEX AAA ENDO ; ATB ADVANCE PTA DILA ;

B. Braun: VENA TECH LP VENA CA

Covidien (Valley Lab): RETURN PAD ; PENCIL CAUTERY ROCKE ; FORCE FX-C ESU

AngioDynamics: DISPRESIVE PAD (TIN/

Celsion Re-Submits Protocol for Special Protocol Assessment (SPA) for Pivotal Phase III Liver Cancer Trial

COLUMBIA, Md., Dec 10, 2007 (BUSINESS WIRE) -- CLN charts news PowerRating -- CELSION CORPORATION (AMEX: CLN charts news PowerRating) today announced it has re-filed for a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA) for the design of its phase III trial of ThermoDox (Thermally Sensitive Liposomal Doxorubicin) in combination with radiofrequency ablation (RFA) to treat patients with non-resectable Hepatocellular Carcinoma (HCC).
The submission maintains the previously proposed global trial design, with clarifications requested by the FDA. The Phase III trial will continue to be a randomized, double-blinded trial, and examine the efficacy and safety of ThermoDox plus RFA versus RFA-alone. As proposed, the global trial is expected to enroll and randomize approximately 600 patients.

full article >> http://www.tradingmarkets.com/.site/news/Stock%20News/899661/

A Tech Valley leader grows

$5M AngioDynamics site opens, top executive upbeat about the future
QUEENSBURY -- AngioDynamics Inc. unveiled its gleaming new 36,000-square-foot warehouse and distribution facility here Friday, giving the public and U.S. Rep. Kirsten Gillibrand a view of what the future may hold for the growing medical-device manufacturer.
After all, on any given day, the company is either the second- or third-largest public company in the Capital Region in terms of stock market capitalization at roughly $440 million.
That's something Chief Executive Eamonn Hobbs says is a well-kept secret he'd like more people to know about.
In fact, the company shipped 16,000 of its products on a recent day, a record for the company, which earned $2.4 million on sales of $37.5 million during the quarter that ended Aug. 31.

read the full article >> http://timesunion.com/AspStories/story.asp?storyID=645502&category=BUSINESS&newsdate=12/8/2007

Diomed Comments on Status Conference in VNUS Litigation

ANDOVER, Mass., Dec 10, 2007 (BUSINESS WIRE) -- DIO charts news PowerRating -- Diomed Holdings, Inc. (AMEX: DIO - News), a leading developer and marketer of minimally invasive medical technologies, including its patented EndoVenous Laser Treatment (EVLT(R)) for varicose veins, announced that on Friday December 7, 2007 District Judge Maxine M. Chesney of the U.S. District Court for the Northern District of California held a status conference relating to the patent infringement lawsuit by VNUS Medical Technologies, Inc. ("VNUS") against Diomed and its co-defendants, Angio-Dynamics, Inc. and Vascular Solutions, Inc. During the conference, no trial date was set.
The trial, originally scheduled to commence on October 29, 2007, had been delayed based on a conflict in the court's schedule. A further status conference has been set for January 11, 2008, at which time the judge may set a trial date or may defer doing so until later.

full press release >> http://www.tradingmarkets.com/.site/news/Stock%20News/899786/

SPH Study: Chronic Kidney Disease Now Common in the United States

There is a high prevalence of chronic kidney disease in the United States, which has risen over the past decade, according to a study led by researchers at the Johns Hopkins Bloomberg School of Public Health.
The study found that the overall prevalence of chronic kidney disease increased from 10 percent of the population during a period from 1988 to 1994 to 13 percent from 1999 to 2004. The researchers conclude that the increase is partly due to the rise in the number of Americans with diabetes and hypertension and the aging of the population. The study is published in a recent edition of JAMA.
Chronic kidney disease increases the risk for complications from medications cleared by the kidney, hypertension, anemia, bone disease, death from cardiovascular disease and ultimately kidney failure, which requires treatment with kidney transplantation or dialysis.

read the full article >> http://www.jhu.edu/~gazette/2007/10dec07/10chronic.html

Increased Reimbursement to Drive Uterine Fibroid Embolization Procedures

Millennium Research Group data shows UFE accounts for nearly 50% of all embolic particle procedures in Q3 2007
WALTHAM, Mass., Dec. 10 /PRNewswire/ -- Millennium Research Group's US Interventional Radiology Marketrack results indicate that uterine fibroid embolization (UFE) accounted for nearly 50% of all embolic particle procedures in Q1 to Q3 2007. Given the recent Medicare announcement regarding an increase in UFE procedure reimbursement, this penetration will rise as improved coverage drives procedure volumes throughout 2008.
The Centers for Medicare and Medicaid Services (CMS) recently issued its Final Rule regarding hospital outpatient reimbursement for UFE, which will increase by 113% -- from 2,642 to $5,639 per procedure -- beginning January 1, 2008.
"This means that the embolic microsphere and particle market will grow faster than originally expected," says Philip Scrutton, Analyst at Millennium Research Group. "Market leaders such as BioSphere Medical and Boston Scientific will benefit as their embolic microspheres and particles see increased usage in UFE procedures."

full article >> http://sev.prnewswire.com/health-care-hospitals/20071210/NEM00610122007-1.html

Radio Waves Fire Up Nanotubes Embedded in Tumors, Destroying Liver Cancer

Cancer cells treated with carbon nanotubes can be destroyed by noninvasive radio waves that heat up the nanotubes while sparing untreated tissue, a research team led by scientists at The University of Texas M.D. Anderson Cancer Center and Rice University has shown in preclinical experiments. In a paper published in the journal Cancer, the researchers demonstrated that the technique completely destroyed liver cancer tumors in rabbits. There were no side effects noted. However, some healthy liver tissue within 2 to 5 millimeters of the tumors sustained heat damage due to nanotube leakage from the tumor.
"These are promising, even exciting, preclinical results in this liver cancer model," said lead investigator Steven Curley, M.D., of M.D. Anderson. "Our next step is to look at ways to more precisely target the nanotubes so they attach to, and are taken up by, cancer cells while avoiding normal tissue."

full article>> http://nanotechwire.com/news.asp?nid=5349

NeuroVasx, Inc. Announces $8.5 Million Private Placement and Completion ofcPAX Aneurysm Treatment Study

MAPLE GROVE, Minn., Dec. 7 /PRNewswire/ -- NeuroVasx, Inc. announced todaythe completion of a private placement of common stock in the amount of$8,500,000 with MJSK of Minneapolis, MN and the Stephens Group of Little Rock,AR. Terms of the financing were not disclosed. The company also announced completion of long term follow up on 20 patients treated with the cPAX Aneurysm Treatment System in a clinical study which was completed in May. The company intends to announce the resultsof the study at the 2008 International Stoke Conference in February.

full article>> http://www.reuters.com/article/pressRelease/idUS136424+07-Dec-2007+PRN20071207

Bard Signs Agreement to Acquire LifeStent® from Edwards Lifesciences

MURRAY HILL, N.J.--(BUSINESS WIRE)--C. R. Bard, Inc. (NYSE: BCR) today announced that it has signed an agreement to acquire the assets of the LifeStent® product family from Edwards Lifesciences Corporation, headquartered in Irvine, California. The transaction includes cash payments of approximately $74 million upon closing and up to an additional $65 million on the achievement of certain milestones including regulatory approvals. Bard’s Peripheral Vascular division, located in Tempe, Arizona, will assume marketing responsibility for the product. The company expects to close the transaction following the satisfaction of customary conditions, including Hart-Scott-Rodino clearance.

read the full press release>> http://www.businesswire.com/portal/site/google/index.jsp?ndmViewId=news_view&newsId=20071207005084&newsLang=en

November 2007 510(k) Approvals

Listed from most recent; click on the link to view a summary of the 510(k).

Emcision, ltd.: habib endoblate
Medcomp: pro-picc, basic tray; long wire tray; ba
Vascular Solutions, inc.: twin-pass otw catheter, model 5201
Merit Medical Systems, inc.: prelude and prelude pro sheath introduce
PFM Medical, inc: pfm picc
Merit Medical Systems, inc.: resolve biliary drainage catheter
C.R. Bard, inc.: titanium powerport isp implanted port wi
Possis Medical, inc.: angiojet ultra; xmi (105041), xvg (10504
Fox Hollow Technologies: the rinspirator, models fg09770, fg08776
Enpath Medical, inc.: viapeel peelable introducer
Cook, inc.: cxi support catheter
Medtronic Vascular: complete se self expanding biliary stent
Cook, inc: gunter tulip vena cava filter
Gambro, inc.: phoenix hemodialysis delivery system, ve
C.R. Bard inc: titanium powerport isp implanted port

German firm buys Renal Solutions

Seven years after it was spun off from its parent company in Lafayette, Renal Solutions Inc. has been bought by a German-based firm with operations worldwide.
Fresenius Medical Care AG & Co. paid $190 million to acquire RSI, which was created by HemoCleanse Inc. to develop and commercialize technology that makes it possible to provide at-home dialysis for chronic kidney disease patients.
Fresenius plans to leverage the technology to strengthen its position in the home hemodialysis market, which is expected to be a $4 billion market in the next 10 years.

read the full article>> http://www.jconline.com/apps/pbcs.dll/article?AID=/20071206/BUSINESS/712060332

Radiofrequency Ablation Growing in Popularity as a Treatment for Cancer

Cancer treatment procedures using radiofrequency ablation will grow at almost 12% in the US over the next five years, according to Millennium Research Group.

Waltham, Massachusetts (PRWEB) December 6, 2007 -- Millennium Research Group forecasts that radiofrequency ablation (RFA) procedures for cancer treatment will grow at almost 12% over the next five years in the US. According to Millennium Research Group's US Markets for Nonvascular Interventional Radiology Devices 2008 report, over 21,000 RFA procedures will be performed in 2007 on patients with liver, kidney, breast, lung, and metastatic bone cancers; by 2012, RFA procedures will reach over 36,000.
Physicians are opting for this surgery due to its minimally invasive nature and its ability to safely and precisely ablate small tumors. If the continued release of clinical evidence supports RFA treatment as a viable alternative to surgical resection, physician confidence in and the subsequent adoption of RFA devices take place.
"RFA can be used in cases where surgical resection poses too great of a risk to the patient," says Stephanie LaBelle, Analyst at MRG. "As a result, RFA increases the treatable patient population."
The US Markets for Nonvascular Interventional Radiology Devices 2008 report includes coverage of many industry competitors, including AngioDynamics, Boston Scientific, and Covidien.

read the full article>> http://www.prweb.com/releases/2007/12/prweb574320.htm

Smiths Medical Receives Clearance for New Safety Needle to Help Protect Clinicians and Minimize Patient Discomfort

ST. PAUL, Minn.--(BUSINESS WIRE)--SMITHS Medical, part of the global technology business Smiths Group, today announces that it has received clearance from the US Food and Drug Administration (FDA) for a new safety needle designed to protect clinicians from needlestick injuries and minimize discomfort for patients.
Smiths Medical’s GRIPPER® Micro Safety Needle is similar in design to the popular GRIPPER PLUS® Safety Needle introduced in 2002 but includes advancements such as a low profile infusion site and a blunt cannula.
The GRIPPER® Micro safety needle is used to deliver medications intravenously through a patient’s implanted port. The two-piece needle system includes an inserter and an infusion site. After the GRIPPER® Micro needle is inserted into a patient’s implanted port, the inserter is removed, leaving behind a small, low profile infusion site with a blunt cannula, which can be used to administer medication or withdraw fluid. The inserter’s unique safety arm provides an audible ‘click’ when it is lifted, giving clinicians further assurance that the needle is locked in a safe position for disposal, protecting those who come into contact with it.
The infusion site’s small size and foam pad is designed to provide increased comfort for patients undergoing long-term infusion protocols such as chemotherapy.

read the full press release>> http://www.businesswire.com/portal/site/google/index.jsp?ndmViewId=news_view&newsId=20071205005718&newsLang=en

Diomed Holdings Reports Notice Regarding AMEX Listing Standards

ANDOVER, Mass.--(BUSINESS WIRE)--Diomed Holdings, Inc. (AMEX: DIO - News), a leading developer and marketer of minimally invasive medical technologies, including its patented EVLT® laser treatment for varicose veins, today announced that it has received notice from the American Stock Exchange advising the Company that, based on the Company’s balance sheet included in its most recent quarterly report on Form 10QSB, it did not satisfy Sections 1003(a)(ii) and (iii) of the AMEX Company Guide’s standards for continued listing on the Exchange. The standards require that a company maintain at least $4 million in stockholders’ equity if the company has sustained losses from continuing operations in three of its four most recent fiscal years and at least $6 million in stockholders’ equity if the company has sustained losses from continuing operations in its five most recent fiscal years.
According to the notice, the Company must submit a Plan by January 3, 2008 advising the Exchange what plans it has taken or will take to bring it into compliance with the continued listing standards by February 3, 2009. Though there can be no guarantee that the Plan will be accepted by the Exchange, the Company believes it will be able to file a plan acceptable to the Exchange and expects to do so by January 3, 2008.

read the full press release>> http://www.businesswire.com/portal/site/google/index.jsp?ndmViewId=news_view&newsId=20071204006251&newsLang=en

Biolitec Says Sales May Increase 35% on U.S. Demand for Lasers

Dec. 5 (Bloomberg) -- Biolitec AG, the German company whose prostate-therapy laser was approved in the U.S. in 2007, expects revenue to rise as much as 35 percent this year, Chief Executive Officer Wolfgang Neuberger said.
``We expect a growth rate of 30 percent or maybe 35 percent'' this fiscal year, Neuberger said in a telephone interview Nov. 30. Sales at Jena, Germany-based company rose 34 percent to 39 million euros ($57.5 million) in the year ended June 30.
North American sales accounted for 52 percent of Biolitec revenue in the year ended in June, compared with 42 percent a year earlier, as U.S. demand for cosmetic and medical lasers increased. The German company has 20 percent of the U.S. market for prostate laser therapy and aims to have 40 percent by the end of 2008, Neuberger said.
Biolitec's lasers for prostate treatment vaporize enlarged tissue, while their heat cauterizes blood vessels to stem bleeding.

read the full article>> http://www.bloomberg.com/apps/news?pid=20601085&sid=adlbE4zMUciY&refer=europe

CardioMEMS Closes $33 Million Series E Financing and Appoints New CFO

ATLANTA--(HSMN NewsFeed)--CardioMEMS, Inc., the pioneer in wireless sensing for the management of chronic cardiovascular diseases such as Heart Failure, today announced the closing of its Series E Preferred Stock financing for $33 million of equity funding led by Arcapita Ventures. Joining Arcapita in this financing round are existing investors Boston Millennia Partners, Medtronic, Inc., Easton Capital Partners, Foundation Medical Partners, and Arboretum Ventures, along with new investors Deerfield Capital Management, Vision Capital Advisors, Aperture Venture Partners and Rockport Venture Securities.
“We are pleased with the continued support of Arcapita Ventures and our existing and new investors,” stated Jay Yadav, MD, Chairman and CEO of CardioMEMS, Inc. "This is a very exciting time for CardioMEMS as we conduct our randomized trial aimed at reducing heart failure hospitalizations with our wireless sensing technology. The absence of leads and batteries in our technology, we believe, provides a substantial safety advantage.”

Full text >>

Medtronic, Medical-Device Makers Seek to Block Patient Suits

Dec. 4 (Bloomberg) -- Medtronic Inc. and other medical- device makers have a chance to win a new shield from patient lawsuits in a case before the U.S. Supreme Court.
In arguments today in Washington, the justices will consider whether patients can press product-liability lawsuits over devices cleared for sale by the Food and Drug Administration's most rigorous approval process. A federal appeals court barred a suit that claims a New York man suffered permanent injury when a Medtronic heart catheter burst during an angioplasty.

read the full article>> http://www.bloomberg.com/apps/news?pid=20601087&sid=aoseE8nKGInY&refer=home

Recap: October / November 2007 Product Recalls

B. Braun (BIS) VenaTech LP Vena Cava Filter System
Reason: Sterility (package integrity) compromised: package sealing problem leaving packaging being partially open on one of the four sealed Tyvek pouch edges.
full text>> http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?ID=65749

Toshiba Digital Radiography System with Flat Panel Detector
Reason: System Lock-up: When performing DAS One Shot, the system may lockup due to a software timing error.
full text>> http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?ID=65789

Medtronic Files PMA Application for FDA Approval of Talent(TM) Abdominal Stent Graft System

Submission Further Confirms Broad Patient Benefits of Endovascular Abdominal Aortic Aneurysm Therapy Provided by Medtronic, the Market Leader in Stent Graft Technologies

MINNEAPOLIS--(HSMN NewsFeed)--Medtronic, Inc. (NYSE:MDT ), today announced that it has filed the final module of its Pre-Market Approval (PMA) application with the U.S. Food and Drug Administration (FDA) for the Talent™ Abdominal Stent Graft System. The Talent Abdominal Stent Graft is a minimally-invasive device that treats dangerous bulges in the aorta, the body’s largest artery that can rupture without warning.

Full text >>

The Endovascular Aneurysm Repair (EVAR) Market Is Expected To Reach US$1.3 Billion by 2012 According To the Report 'Abdominal Aortic Aneurysm...

DUBLIN, Ireland--(BUSINESS WIRE)--November 30, 2007--Research and Markets (http://www.researchandmarkets.com/reports/c76068) has announced the addition of Abdominal Aortic Aneurysm Endovascular Technology & Market Forecasts to their offering.
It is estimated that approximately 4.5 million people in the developed word are living with an abdominal aortic aneurysm and each year 600,000 new cases are diagnosed.
Patients typically have no symptoms and, when they are diagnosed, they often undergo complex open surgical repair. Stent-graft therapy provides a minimally-invasive alternative, with reduced recovery times and potentially improved survival rates. By the end of 2006 the global market for abdominal aortic aneurysm stent-grafts has reached US$610 million and has been growing at double digit rate. Technical improvements in graft design and advancement in delivery techniques will result in the increased application of Endovascular Aneurysm Repair (EVAR) and the market is expected to reach US$1.3 billion by 2012.

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

Light-assisted stab phlebectomy: report of a technique for removal of lower extremity varicose veins.

Lawrence PF, Vardanian AJ.
Division of Vascular Surgery, Gonda (Goldschmied) Vascular Center, University of California, Los Angeles, CA 90095-6908, USA. pflawrence@mednet.ucla.edu

We report a new technique to remove varicose veins and reduce recurrence from missed veins. A rigid cannula with a light source injects tumescent solution and transilluminates under veins. Varicose veins are removed with stab phlebectomy using a modified crochet hook and mosquito clamp. Additional tumescent solution flushes hematomas and compresses empty vein channels, resulting in less pain, bleeding, and pigmentation. More than 200 patients have undergone light-assisted stab phlebectomy at the Gonda Vascular Center, with high patient and surgeon satisfaction. This sutureless technique allows complete and rapid varicose branch vein removal with few missed varicose veins, little bruising, and an excellent cosmetic result.

J Vasc Surg. 2007 Nov;46(5):1052-4

Analysis of tip malposition and correction in peripherally inserted central catheters placed at bedside by a dedicated nursing team.

Trerotola SO, Thompson S, Chittams J, Vierregger KS.
Division of Interventional Radiology, Department of Radiology, University of Pennsylvania Medical Center, 1 Silverstein, 3400 Spruce St, Philadelphia, PA 19104, USA. streroto@uphs.upenn.edu
PURPOSE: To analyze the patterns of postplacement tip malposition in peripherally inserted central catheters (PICCs) placed at bedside, and to describe results of bedside and imaging-guided correction of tip malposition. MATERIALS AND METHODS: With use of a quality assurance database, all episodes of tip malposition in PICCs placed at bedside were reviewed. Catheter tip location, success or failure of bedside repositioning (in a subset of patients, by using over-the-wire techniques), findings in the interventional radiology (IR) division, and tip correction method used in the IR suite (repositioning vs replacement) were determined with a review of medical records. RESULTS: During the 18-month study period, 2,367 attempts were made to place a PICC at bedside; 1,654 attempts (70%) were initially successful. Of these, 163 tips (10%) were malpositioned. Complete records for 132 malpositioned tips were available for analysis. Malpositioned tips were located in the ipsilateral internal jugular vein in 45 of the 132 cases (36%), axillary vein in 36 cases (27%), ipsilateral subclavian vein in 25 cases (19%), ipsilateral brachiocephalic vein in 15 cases (11%), contralateral subclavian vein in four cases (3%), contralateral brachiocephalic vein in two cases (2%), contralateral internal jugular vein in one case (1%), and subclavian tributary in one case (1%). In three cases (2%), the tip was coiled in the superior vena cava. Malposition was corrected with catheter exchange in 76 of the 132 cases (58%), repositioning in 48 cases (36%), or removal in one case (1%). Spontaneous correction occurred in seven of the 132 malpositioned tips (5%). One hundred nine tips (83%) were repositioned in the IR division with use of imaging guidance, with 100% success. Twenty-five attempts were made to correct malposition at bedside; 16 of those attempts (64%) were successful. CONCLUSION: Tip malposition is relatively frequent with bedside placement of PICCs. Preliminary data suggest that most malpositions can be corrected with bedside techniques. Spontaneous correction may occur but is relatively uncommon.

J Vasc Interv Radiol. 2007 Apr;18(4):513-8.

Radiofrequency Ablation Is Safe for Liver Cancer Lesions Close to the Diaphragm: Presented at RSNA

CHICAGO, IL -- November 30, 2007 -- Researchers said that radiofrequency ablation of liver cancer that is close to or abutting the diaphragm are still viable targets that can be safely treated, researchers reported here at the 93rd Scientific Assembly and Annual Meeting of the Radiological Society of North America (RSNA). In a retrospective study, Tae Wook Kang, MD, Radiologist, Samsung Medical Center at Sungkyunkwan University School of Medicine, Seoul, Korea, and colleagues identified patients who underwent radiofrequency ablation at the experience at their centre between 2000 and 2006.

full article>> http://www.docguide.com/news/content.nsf/news/852571020057CCF6852573A3006A1E6C