Aporo Biomedical Announces Global Licensing Agreement for Proprietary Polymers Used to Treat Structural Heart Disease

Deal With mNEMOSCIENCE GmbH Uniquely Positions Aporo to Deliver Innovative Biodegradable Medical Devices
SAN FRANCISCO--(BUSINESS WIRE)--Aporo Biomedical, a San Francisco/Bay Area-based medical device company, today reported an exclusive global licensing agreement with mNEMOSCIENCE GmbH for its proprietary biodegradable shape memory polymers (BIO-SMP™). Aporo’s goal is to provide significant clinical value by delivering novel transcatheter devices that close defects and then biodegrade over time, leaving behind no permanent implant. Initially, Aporo will use these materials to treat Patent Foramen Ovale (PFO), a type of structural heart disease that involves closing an open tunnel between the upper left and right chambers of the heart. In the future, the company will use the polymers in devices to treat Atrial Septal Defect (ASD), another structural heart disease, and for vascular closure after catheter-based interventional procedures.

press release >> http://www.businesswire.com/portal/site/google/index.jsp?ndmViewId=news_view&newsId=20080130005434&newsLang=en

Nuvelo Initiates Phase 1 Clinical Trial of Thrombin Inhibitor, NU172

SAN CARLOS, Calif., Jan. 30 /PRNewswire-FirstCall/ -- Nuvelo, Inc. today announced that it has enrolled the first patient in a single-center, Phase 1 trial to determine the safety, tolerability and pharmacokinetics of escalating doses of NU172, a thrombin-inhibiting aptamer, in approximately 30 healthy male volunteers.
"This proof-of-concept trial will allow us to quickly determine NU172's potential to achieve rapid onset and offset of anticoagulation," said Michael Levy, executive vice president of research and development for Nuvelo. "We look forward to sharing top-line data from this trial in the first half of 2008."
NU172 is an aptamer designed to directly inhibit thrombin's ability to stimulate blood clot formation in the setting of medical procedures where human blood is exposed to foreign materials. Specifically, NU172 is being studied for use as a potential short-acting anticoagulant during procedures such as coronary artery bypass graft surgery and percutaneous interventions. Data from early animal models suggest that NU172 has the potential for predictable anticoagulant effects, rapid onset and offset of action, and avoidance of heparin-induced thrombocytopenia.

full article >> http://money.cnn.com/news/newsfeeds/articles/prnewswire/AQW05130012008-1.htm

ISSYS, Inc. Awarded a Patent for Wireless, Batteryless, Implantable Sensors

YPSILANTI, MI--(Marketwire - January 30, 2008) - Integrated Sensing Systems, Inc. (ISSYS) announced today that the U.S. Patent Office has granted a patent titled "Anchor for Medical Implant Placement and Method of Manufacture" (U.S. Patent No. 7,317,951) which covers the design and manufacturing of advanced, catheter-delivered, anchors for miniature, wireless, batteryless, implantable sensors within the heart for chronic, non-invasive monitoring of cardiovascular biological pressures.
Dr. Nader Najafi, ISSYS CEO, stated that "This patent is a major step towards the manifestation of ISSYS' technology as a viable medical product for effective monitoring of cardiovascular patients, in particular for congestive heart failure (CHF). ISSYS' miniature, implantable, wireless sensing technology distinguishes itself from other competitors by being the only current platform capable of monitoring the left side of the heart. Due to the shortcomings of their technologies, our competitors have focused on pulmonary artery cardiac pressure monitoring, which is better than no monitoring but not the desirable cardiac pressure waveform. The left atrium pressure (monitored by ISSYS' sensors) is the ideal signal for effective chronic treatment of CHF patients."

press release >> http://www.marketwire.com/mw/release.do?id=815735

EV Today January 2007

FEATURED TECHNOLOGY:
The Mynx Vascular Closure Device By Gary M. Ansel, MD, and Joseph M. Garasic, MD
IMAGING & DIAGNOSTICS
Multidetector CT in the Evaluation of Thoracic Aortic Disease By Peter S. Fail, MD, FACC, FACP, and Vinod Nair, MD, FACC
COVER STORY
Iliofemoral Deep Venous Thrombosis By George H. Meier, MD, RVT, FACS
EVAR of a Large AAA With a Pelvic Kidney By Tara M. Mastracci, MD; Roy K. Greenberg, MD; and Kate Pfaff, BS
Managing Iatrogenic Injury and Arteriovenous Fistulae By David L. Dawson, MD
Endovascular Salvage of a Displaced Carotid Filter By Donald T. Baril, MD, and Mark H. Wholey, MD
Complications of Renal Artery Stenting By Andrew Holden, MBChB, FRANZCR
Acute Descending Thoracic Dissection By Rodney A. White, MD; Carlos E. Donayre, MD; Irwin Walot, MD; Maurice Lippmann, MD; Dongyu Tony Fang, MD; and George Kopchok, BS
Transbrachial Approach for Carotid Artery Stenting By Vinay Kumar, MD
Percutaneous Repair of a Giant Chronic TAAA Dissection By Shigeki Hirayama, MD; Yuji Kanaoka, MD; Makoto Sumi, MD; and Takao Ohki, MD, PhD
Endovascular Treatment of Renal Parenchymal Hemorrhage By Donald T. Baril, MD, and Mark H. Wholey, MD
Acute-on-Chronic Mesenteric IschemiaBy Jack Wei Chieh Tan, MBBS, and John R. Laird, Jr, MD
Hybrid Repair of Thoracoabdominal Aortic Aneurysms By Lawrence Rajan, MD; Kathryn Dougherty; Igor Gregoric, MD; and Neil E. Strickman, MD
FEATURED TECHNOLOGYFiberNet Embolic Protection System
Perspectives on CAS and Embolic Protection Featuring Subbarao V. Mylavarapu, MD, and J. Michael Bacharach, MD

Memry Corp. Launches 'Micro to the Max' Product Line for Medical Devices

www.memry.com/ - Hawk Associates, Inc. Investor Relations Information: Julie Marshall or Frank Hawkins, 305-451-1888 info@hawkassociates.com Memry Corporation (AMEX:MRY), a leading provider of nitinol and polymer components for medical devices, today announced the launch of 'Micro to the Max,' a new product line that is focused exclusively on a precision micro component platform for medical devices
requiring minute-scale components. The 'Micro to the Max' launch will be at the annual Medical Design & Manufacturing Conference West from January 28 through January 31 at the Anaheim Convention Center in California, where Memry is exhibiting its full line of products for the medical devices market.
full article >> http://www.pr-inside.com/memry-corp-launches-micro-to-the-r411465.htm

New Study Analyzes US Markets for Peripheral Vascular Devices

New Study Analyzes US Markets for Peripheral Vascular Devices
DUBLIN, Ireland--(BUSINESS WIRE)--Research and Markets (http://www.researchandmarkets.com/reports/c80861) has announced the addition of US Markets for Peripheral Vascular Devices to their offering.
The PV market was valued at roughly $1.9 billion in 2006 and will increase at a rapid CAGR of over 10% throughout the forecast period.
The peripheral vascular (PV) device market comprises PV stents, percutaneous transluminal angioplasty (PTA) balloon catheters, embolic protection devices (EPDs), inferior vena cava filters (IVCFs), aortic stent grafts, synthetic surgical grafts, and accessory devices.

press release >> http://www.businesswire.com/portal/site/google/index.jsp?ndmViewId=news_view&newsId=20080129005085&newsLang=en

Escalon(R) Announces FDA 510(K) Clearance for VascuView(TM) Visual Ultrasound System For Assisted Vascular Access

WAYNE, Pa., Jan. 29 /PRNewswire-FirstCall/ -- Escalon Medical Corp. today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the VascuView(TM) Visual Ultrasound System for use with assisted vascular access. Its subsidiary, Escalon Vascular Access, Inc., plans to commence shipments of the product in the United States immediately.
"We are excited to announce the FDA clearance and introduction of the new VascuView(TM) Visual Ultrasound System," said Michael O'Donnell, President of Escalon Vascular Access. "Developed with doctors and clinicians ultrasound needs in mind, the VascuView(TM) system couples unparalleled portability with a large image display and intuitive touchscreen operation which allow users to focus on the task at hand. Whether mounted on a stand, used table top bedside, or fit into a carrying case for field use, the VascuView(TM) is highly adaptable to the challenges of varying departmental environments within a hospital."
full article >> http://money.cnn.com/news/newsfeeds/articles/prnewswire/NYTU07429012008-1.htm

BioSphere Medical Receives Market Clearance to Sell Embosphere® Microspheres in the People’s Republic of China

BioSphere’s State-of-the-Art Embolic Now Available to the World’s Largest Population of Patients with Primary Liver Cancer Tumors
ROCKLAND, Mass.--(BUSINESS WIRE)--BioSphere Medical, Inc. (Nasdaq: BSMD), 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 reported that the Medical Device Department of the State Food and Drug Administration of the People’s Republic of China has approved BioSphere’s Embosphere Microspheres for clinical use for vascular embolizations, arteriovenous malformations, hypervascularized tumors, and symptomatic uterine fibroids. BioSphere expects to commence shipments of Embosphere Microspheres to China in the first quarter of 2008.

press release >> http://www.businesswire.com/portal/site/google/index.jsp?ndmViewId=news_view&newsId=20080128005699&newsLang=en

Terumo Launches the New AZUR(TM) Peripheral HydroCoil(R) Embolization System with Expanding Hydrogel Technology

SOMERSET, N.J., Jan. 28 /PRNewswire/ -- The newest product offered by Terumo is literally expanding the company's interventional device portfolio.
Terumo Interventional Systems announces the launch of the AZUR Peripheral HydroCoil Embolization System for the occlusion of blood vessels, vascular malformations, and aneurysms. AZUR is the only peripheral platinum coil embolization system with a hydrogel coating that expands when introduced into the bloodstream, delivering greater filling and mechanical occlusion - all with fewer coils.
AZUR's hydrogel coating undergoes limited expansion within the first 3 minutes, and fully expands within 20 minutes. The result is greater filling and mechanical stability with fewer coils - nearly 5 times more filling volume for the 0.018" coil and 4 times more filling volume for the 0.035" coil (versus platinum coils of the same size).
In addition to its unique HydroCoil technology, AZUR is the only peripheral embolization system to offer a truly detachable system, giving physicians the ability to detach coils in less than a second and at the push of a button. With the capability to withdraw and reposition the coil until the coil is securely placed, the system minimizes the risk of non-target embolization and coil migration. This offers a whole new level of control, making it ideal for high-flow areas and challenging vascular anatomy.

press release >> http://sev.prnewswire.com/medical-pharmaceuticals/20080128/CLM08728012008-1.html

Cook Incorporated Files IDE Application for Zenith Branch Vessel Graft with U.S. FDA

BLOOMINGTON, Ind.--(HSMN NewsFeed)--Cook Incorporated, the world leader in endovascular repair of aortic disease, has filed an Investigational Device Exemption (IDE) for a new type of endograft designed to treat patients with aortoiliac or iliac aneurysms that have been difficult to treat endovascularly with currently available designs.
The company has asked the U.S. Food and Drug Administration (FDA) for permission to initiate a clinical trial of the Zenith Branch Endovascular Graft-Iliac Bifurcation with the H&L-B One Shot Introduction System at 10 sites. Once the application has been reviewed and approved, National Principal investigator W. Anthony Lee, M.D., associate professor of surgery at the University of Florida in Gainesville, Florida, will lead the trial along with a select group of U.S. vascular surgeons at leading healthcare institutions around the country. The trial is expected to take about one year to enroll.

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Ash Access Technology, Inc. Completes Patient Enrollment in AZEPTIC Trial for Zuragen(R)

Twenty-Five Dialysis Facilities Across the United States Are Participating in the Study

LAFAYETTE, IN--(HSMN NewsFeed)--Jan 24, 2008 -- Ash Access Technology, Inc., a privately held specialty pharmaceutical and medical device company focused on vascular access innovations, announced today that patient enrollment in the AZEPTIC Trial for its flagship antimicrobial / antithrombotic therapy Zuragen® was completed in December of last year. The pivotal trial is a multi-centered, randomized study evaluating the efficacy and safety of Zuragen® for the prevention and treatment of catheter-related bloodstream infection (CRBSI) in end-stage renal disease patients requiring the use of a tunneled central venous catheter for hemodialysis compared to heparin, the current standard of care. The trial enrolled 415 patients at 25 dialysis facilities across the United States. Portions of the AZEPTIC Trial were financed through grants awarded by the National Institutes of Health (NIH) and the Indiana 21st Century Research and Technology Fund.

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Cardiovascular Systems Plans IPO

NEW YORK — Medical device company Cardiovascular Systems Inc., which develops treatment systems for blood vessel disease, registered with the Securities and Exchange Commission on Tuesday for an initial public offering.
The St. Paul, Minn.-based company did not disclose the expected size or price range of the IPO, but indicated the offering may total up to $86.3 million. Cardiovascular Systems noted that the total offering price was estimated solely to calculate its registration fee and may change.
Cardiovascular Systems' initial product is a minimally invasive catheter system used to treat peripheral arterial disease, or PAD, in which plaque deposits build up on the walls of vessels and reduce blood flow.
According to the company, the Diamondback 360 Orbital Atherectomy System uses a diamond grit coated offset crown to sand away both soft and calcified plaque in vessels.
Cardiovascular Systems began a limited commercial introduction of its product in the U.S. in September 2007. Through Dec. 31, the company shipped more than 1,700 single-use catheters to 57 hospitals and generated about $4.6 million in revenue.
full article >> http://www.chron.com/disp/story.mpl/ap/fn/5477855.html

Nuvelo Reports Results From Phase 3 NAPA Program In Acute Peripheral Arterial Occlusion

(RTTNews) - Nuvelo Inc. announced results from the Phase 3 NAPA or Novel Arterial Perfusion with Alfimeprase program evaluating alfimeprase in acute peripheral arterial occlusion or PAO.
According to the company, 34.9% of patients receiving alfimeprase achieved primary endpoint of 30-day open vascular surgery avoidance in the NAPA-2 clinical trial, whereas 37.2% of patients receiving intra-thrombus placebo and 18.4% of patients receiving peri-thrombus placebo achieved primary endpoint.

Johnson & Johnson Cordis Balloon Catheters Recalled for Potentially Fatal Flaw

Johnson & Johnson has recalled balloon catheters used in angioplasties following reports that the defective medical devices injured two people. The Fire Star-RX and Dura Star-RX PTCA balloon catheters, which are manufactured by Johnson & Johnson’s Cordis unit, do not deflate properly and could potentially cause fatal injuries. For that reason, the Food & Drug Administration (FDA) has deemed the Johnson & Johnson Cordis balloon catheter recall a Class I recall. Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.
Balloon catheters are used in a medical procedure (known as percutaneous transluminal coronary angioplasty or PTCA) to open narrowed or blocked blood vessels or arteries of the heart. According to FDA alert, the recalled Cordis balloon catheters were manufactured in Mexico from February, 2007 through December, 2007 and distributed worldwide from March 26, 2007 through January 8, 2008. Dura Star RX balloon catheters were distributed in the U.S. on August 29, 2007 and Fire Star RX balloon catheter was distributed in the U.S. on August 31, 2007. All Fire Star and Dura Star lots 13173912 through 13315455, plus 52 additional lots above 13315455 are affected. (No lots above 13329055 are affected).

full article >> http://www.newsinferno.com/archives/2457

BTG makes good progress

LONDON (SHARECAST) - Medical innovations outfit BTG said it has made good progress in the first nine months of the year, performing in line with expectations since last October’s update.

In addition, recruitment of patients in the phase II safety study of Varisolve, a treatment for varicose veins without surgery, is on track for the planned finish by June 2008.

Full-year expenditure is anticipated to be in the range £12-14m, while operating and administrative costs are stable and are seen at around £18-19m.

“Over the coming months we expect to report results from our sleep apnoea and head lice clinical studies, initiate the first clinical studies for our migraine and MS programmes, and conclude the US safety study of Varisolve,” said chief executive Louise Makin.

AngioDynamics Highlights Results From Preliminary Study of Centros™ Central Venous Catheter for Hemodialysis

Dr. Stephen Ash Presents Study Results at International Symposium on Endovascular Therapy

QUEENSBURY, N.Y.--(BUSINESS WIRE)--AngioDynamics (NASDAQ:ANGO), a leading provider of innovative medical devices used by interventional radiologists, nephrologists, and surgeons for the minimally invasive treatment of cancer and peripheral vascular disease, today highlighted results from a United States preliminary study of Centros™, a self-centering, tunneled hemodialysis access catheter.

This preliminary study indicates that the self-centering catheter provides highly acceptable flow rates at modest negative pressure without deterioration in flow rate over seven weeks of use, even with tips positioned in the superior vena cava (SVC) rather than within the atrium. Flow rate for Centros at the seven week follow-up point was 401mL/min, compared to the control group of competitive catheters at 348mL/min. (p <>

press release >> http://www.businesswire.com/portal/site/google/index.jsp?ndmViewId=news_view&newsId=20080123006348&newsLang=en

Super-Thin Drug-Free Coating 'Hides' Stent as It Unblocks Heart ArteriesAvoids Deadly Clotting Problems of Drug-Eluting Stents

HOLLYWOOD, Fla., Jan. 21 (HSMN NewsFeed) -- A new stent with a nanothin surface application shows promise in opening and healing blocked heart arteries without the life-threatening dangers of drug-eluting stents, according to a study being presented at the 20th annual International Symposium on Endovascular Therapy (ISET).

The stent coating is 25,000 times thinner than a human hair. Called Polyzene®-F, the treatment is not a drug but a medically inert chemical compound that "hides" the stent from the body.

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Cook Medical Begins Patient Enrollment in STABLE Aortic Dissection Trial

Global Clinical Trial to Evaluate the First Device Specifically Designed to Treat Aortic Dissection has Commenced in Melbourne, Australia

BLOOMINGTON, Ind.--(HSMN NewsFeed)--Cook Medical has begun patient enrollment in the STABLE clinical trial designed to evaluate the Cook Zenith® Dissection Endovascular System for the treatment of Type B thoracic aortic dissections. The technologically advanced device is the first of its kind and was designed specifically to treat aortic dissection, a major cause of mortality worldwide. The first STABLE trial patient was treated by interventional radiologist Peter Mossop, M.D. and cardiac surgeon Ian Nixon, M.D. at St. Vincent’s Public Hospital in Melbourne, Australia.

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Diomed patent defendant files for Chapter 11

Diomed Holdings Inc. reports that Total Vein Solutions LLC, which Diomed sued for patent infringement in 2004, has filed for Chapter 11 bankruptcy protection.
Andover-based Diomed brought suit in 2004 in the U.S. Federal District Court for the District of Massachusetts against Total Vein Solutions of Houston seeking injunctive relief and damages for infringement of Diomed's patent for its EndoVenous Laser Treatment (EVLT) for varicose veins.
According to Diomed, on Jan. 17, 2008, prior to a hearing at which the court was expected to rule on Diomed's motion for an injunction against TVS' sales of products that Diomed believes infringes its patent, TVS filed for protection under Chapter 11.

New Report - 'Global Dialysis Market: Hemodialysis Continues to be the Preferred Treatment Method' Now Available

DUBLIN, Ireland-(Business Wire)-January 21, 2008 - Research and Markets (http://www.researchandmarkets.com/reports/c80045) has announced the addition of "Global Dialysis Market: Hemodialysis Continues to be the Preferred Treatment Method" to their offering.
Public healthcare programs reimburse costs for the majority of dialysis treatments in the United States and in Western Europe. The governments of these regions are considering proposals for controlling costs by altering the public-sponsored healthcare programs. This move is likely to change the profitability of the dialysis industry which has been banking on the rapid increase in the number of dialysis patients globally.
The dialysis care market has seen major growth in the last few years and in this segment - the most preferred method of treatment continues to be hemodialysis which accounts for about 90% of all dialysis therapies. Another mode of treatment - peritoneal dialysis remains the preferred method for about 10% of all dialysis patients.

full article >> http://digital50.com/news/items/BW/2001/07/14/20080120005015/new-report-global-dialysis-market-hemodialysis-continues-to-be-the-preferred-trea.html

CELSION Secures Special Protocol Assessment of its Pivotal Phase III Liver Cancer Trial from FDA

COLUMBIA, Md.--(BUSINESS WIRE)--CELSION CORPORATION (AMEX: CLN) today announced that its application for a Special Protocol Assessment (SPA) for its Pivotal Phase III Primary Liver Cancer trial has been agreed to by the US Food and Drug Administration. With this agreement, Celsion will begin immediate implementation of the study which has been planned in detail during the course of FDA’s review. The study is designed to demonstrate the efficacy of Celsion’s proprietary chemotherapeutic, ThermoDox, in combination with radiofrequency ablation as a first line treatment of primary liver cancer, the fifth largest cancer globally with an incidence of over 650,000 cases annually. The study will incorporate about 40 clinical sites in North America, Italy, China, Taiwan, Hong Kong, and Korea, and is planned to enroll 600 patients and specifies the primary end point as Progression Free Survival.

press release >> http://www.businesswire.com/portal/site/google/index.jsp?ndmViewId=news_view&newsId=20080118005068&newsLang=en

Terumo Partners with GHX for More Efficient Electronic Ordering Capabilities

January 17, 2008 -- Somerset, New Jersey -- Terumo Interventional Systems, a strategic business unit of Terumo Medical Corporation (TMC), announces a new partnership between TMC and Global Health Exchange (GHX); expanding its reputation for supplying technologically advanced quality to supply chain management.
Working with GHX and its Electronic Data Interchange (EDI) system, Terumo Interventional Systems is looking to deliver providers what they want—when they want it. Through this e-commerce platform’s unique, streamlined process, hospitals are now easily able to place orders, generate receipts, and change and track orders with Terumo.

full article >> http://www.ptca.org/news/2008/0117_TERUMO.html

AngioDynamics Launches Innovative Central Venous Catheter for Hemodialysis

Novel Catheter Design Promises Enhanced Flow with Fewer Complications

QUEENSBURY, N.Y.--(HSMN NewsFeed)--AngioDynamics (NASDAQ:ANGO ), a leading provider of innovative medical devices used by interventional radiologists, nephrologists and surgeons for the minimally invasive treatment of cancer and peripheral vascular disease, announced today that it launched Centros™, a self-centering, tunneled hemodialysis access catheter.
Designed by Stephen R. Ash, MD, FACP, a worldwide thought leader in the field of hemodialysis access, Centros represents a new approach for central venous dialysis catheters. The distal end of the catheter has a unique curved configuration; placed in the superior vena cava (SVC), its curved tips keep the ports of the catheter centered in the SVC, away from the vein walls. The tips of the catheter are not placed in the atrium, but in the lower third of the SVC.

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Medtronic Launches AneuRx AAAdvantage Stent Graft on New Xcelerant Hydro Delivery System in U.S.

SACRAMENTO, Calif., Jan 17, 2008 (ASCRIBE NEWS via COMTEX) -- MDT -- Continuing its advancement in endovascular therapies for aortic aneurysms, Medtronic announced the U.S. market launch of the AneuRx AAAdvantage Stent Graft on the new Xcelerant Hydro Delivery System, which features a hydrophilic coating designed to aid navigation of the device through tight and tortuous arteries by reducing friction with the artery wall.
In addition, Medtronic has also received approval from the U.S. Food and Drug Administration to introduce its latest generation of packaging materials for the launch of this product.

full article >> http://www.tradingmarkets.com/.site/news/Stock%20News/998007/

Micrus, Genesis in license, development deal

SAN JOSE & REDWOOD CITY, Calif.--(BUSINESS WIRE)--Micrus Endovascular Corporation (Nasdaq:MEND) and privately held Genesis Medical Interventional, Inc. today announced that they have entered into an agreement granting Micrus the rights to Genesis’ F.A.S.T.™ Funnel Catheter™ and clot retrieval system for the treatment of ischemic stroke. The transaction includes an initial upfront payment, future development milestone payments and an undisclosed royalty on potential future products sales.
“Gaining access to this novel occlusion technology clearly expands our product offering and reach into the ischemic stroke market. Additionally, because of the F.A.S.T. Funnel Catheter’s proprietary design, we believe that it will also provide a platform to be used in combination with a number of devices for the treatment of ischemic stroke,” said John Kilcoyne, Micrus Chairman and CEO. “The F.A.S.T. Funnel Catheter system is designed to quickly and easily facilitate the endovascular removal of blood clots and other obstructions while potentially eliminating the limitations inherent in other clot retrieval devices.”
“We are committed to advancing healthcare by designing safe, easy-to-use products to treat occlusive vascular diseases and are pleased to partner with an outstanding company like Micrus to expand use of our system and further validate our endeavors,” said William R. Dubrul, Genesis Chief Executive Officer. “We believe our technology offers a superior and simple proximal occlusion solution that enhances patient safety and comfort. The F.A.S.T. Funnel Catheter has a proven track record in both peripheral and coronary clinical cases completed with excellent results.”

press release >> http://www.businesswire.com/portal/site/google/index.jsp?ndmViewId=news_view&newsId=20080117005302&newsLang=en

Court Rules On Contempt Motion in Diomed Patent Litigation

ANDOVER, Mass.--(BUSINESS WIRE)--Diomed Holdings, Inc. (AMEX: DIO - News), a leading developer and marketer of minimally invasive medical technologies, including its patented EndoVenous Laser Treatment (EVLT®) for varicose veins, today announced U.S. District Judge Nathaniel M. Gorton’s ruling on Diomed’s motion for contempt against AngioDynamics and Vascular Solutions based on the continuing sales of certain laser consoles for the endovenous treatment of varicose veins.
Judge Gorton confirmed the permanent injunction that he originally entered in July 2007 against AngioDynamics and Vascular Solutions covering the sale of both those lasers that were the subject of the infringement proceeding and those that are no more than “colorable variations” of those laser consoles. Judge Gorton did not extend the injunction to those lasers that are being sold with modified versions of the competitors’ disposable procedure kits. Diomed did not request that the court rule on whether the modified kits themselves infringed Diomed’s patent.
press release >> http://biz.yahoo.com/bw/080116/20080116006019.html?.v=1

Radiation Therapy Oncology Group (RTOG) Selects VisionTree Optimal Care™ to Collect Quality of Life Patient Outcomes Data

Organization’s Research Arm Will Use System to Improve Accrual of Data Collection, Validation, Reporting in Prostate Cancer Study
SAN DIEGO--(BUSINESS WIRE)--VisionTree®, the leader in Web-based patient-centered health record management and provider communication systems, announced today that the Radiation Therapy Oncology Group (RTOG) through the American College of Radiology selected its VisionTree Optimal Care™ (VTOC) platform for collecting quality of life patient outcomes data for a pilot study conducted by the RTOG. RTOG will use the system at a select number of member institutions for a prostate cancer study in order to improve the compliance of the data collection, validation and reporting processes.
“Clinical research typically has its greatest challenges in collecting patient-completed information, since it is usually done through a paper or phone survey,” said Benjamin Movsas, M.D., Chair of Radiation Oncology at Detroit’s Henry Ford Hospital and Principal Investigator of an RTOG pilot study testing the VTOC system. “VTOC offers us the ability to move this process to an electronic format through a secure Web portal to collect data in a faster and more compliant manner. The platform also allows us to deliver relevant information to the patient including reminders, education material and study information more effectively in order to manage their treatment. VTOC is a system whose time has come.”
VTOC’s user-friendly, HIPAA-secure, Web-based platform allows consenting patients to fill out their quality of life forms in real-time from any location that has Internet access, including their home. The system can also send patients reminders via e-mail or text messaging to increase the likelihood of their on-going participation.

press release >> http://www.businesswire.com/portal/site/google/index.jsp?ndmViewId=news_view&newsId=20080115006134&newsLang=en

New FDA Recommendations For Unrtrieved Device Fragments

Unretrieved Device Fragments
Audience: Radiologists, surgeons, hospital risk managers, other healthcare professionals[Posted 01/15/2008] FDA advised healthcare professionals of serious adverse events associated with unretrieved device fragments (UDFs). A UDF is a fragment of a medical device that has separated unintentionally and remains in the patient after a procedure. Patients may not be aware that this has occurred. The FDA Center for Devices and Radiological Health receives nearly 1000 adverse event reports each year related to UDFs. The adverse events reported included local tissue reaction, infection, perforation and obstruction of blood vessels, and death. Contributing factors may include biocompatibility of the device materials, location of the fragment, potential migration of the fragment, and patient anatomy. During MRI procedures, magnetic fields may cause metallic fragments to migrate, and radiofrequency fields may cause them to heat, causing internal tissue damage and/or burns. See the FDA Public Health Notification for the Agency's recommendations regarding this issue.[January 15, 2008 - Public Health Notification - FDA]

Smiths Medical Receives FDA Clearance for Expansion of Power Injectable Port Line Including a New Arm Port

ST. PAUL, Minn.--(BUSINESS WIRE)--Smiths Medical, part of the global technology business Smiths Group, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the P.A.S. PORT® T2 POWER P.A.C. and PORT-A-CATH® II POWER P.A.C. Dual-lumen Implantable Access Systems. The new products expand the existing port line from seven to ten systems now available for power injections of contrast media.
Implantable access systems provide a route of delivery for patients requiring long-term medications such as chemotherapy. The portal is implanted under the skin, usually in the chest, and connected to a catheter which threads into a vein. Power-injecting is performed when a patient requires a Contrast Enhanced Computed Tomography (CECT) scan for diagnostic reasons. The power injection procedure requires a higher pressure and flow rate than standard medication infusions so an additional IV line traditionally had to placed in the patient. However, power injections can now be performed through the same portal system used for other medications, such as the PORT-A-CATH®, PORT-A-CATH® II, or P.A.S. PORT® T2 POWER P.A.C. implantable access systems. As a result, the patient is spared the discomfort of an additional needle stick and line placement.

press release >> http://www.businesswire.com/portal/site/google/index.jsp?ndmViewId=news_view&newsId=20080115005261&newsLang=en

BioSphere Medical Reports Results Of Study Published In Journal Of Vascular And Interventional Radiology Concerning Embosphere Microspheres

(RTTNews) - BioSphere Medical Inc. on Tuesday revealed the publication of findings of a study in the January 2008 issue of the Journal of Vascular and Interventional Radiology.
The study data indicated that the Uterine Artery Embolization or UAE or UFE performed using BioSphere's Embosphere Microspheres showed significantly better results in blocking the flow of blood from arteries that feed benign uterine fibroids, compared to procedures performed using Boston Scientific's Contour SE polyvinyl alcohol embolic administered in accordance with Boston Scientific's newly refined treatment protocol.

Court Sets Hearing Date for Diomed Preliminary Injunction Against Total Vein Solutions

ANDOVER, Mass.--(HSMN NewsFeed)--Diomed Holdings, Inc. (AMEX: DIO ), a leading developer and marketer of minimally invasive medical technologies, including its patented EndoVenous Laser Treatment (EVLT(R)) for varicose veins, today announced that the court has set January 18, 2008 as the date to hear Diomed’s request for a preliminary injunction against Total Vein Solutions in its continuing efforts to enforce its U.S. Patent Number 6,398,777 covering the endovascular laser treatment of varicose veins.

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Bard Closes Transaction to Acquire LifeStent(R) from Edwards Lifesciences

MURRAY HILL, N.J.--(HSMN NewsFeed)--C. R. Bard, Inc. (NYSE: BCR ) today announced that it has closed the previously announced acquisition of the assets of the LifeStent® product family from Edwards Lifesciences Corporation, headquartered in Irvine, California. Bard will immediately commence marketing the products globally.

full article >> http://salesandmarketingnetwork.com/news_release.php?ID=2022671

Court Sets June Trial Date in Patent Litigation

ANDOVER, Mass. — Diomed Holdings, Inc. (AMEX: DIO), a leading developer and marketer of minimally invasive medical technologies, including its patented EndoVenous Laser Treatment (EVLT(R)) for varicose veins, today announced that District Judge Maxine M. Chesney of the U.S. District Court for the Northern District of California has set June 23, 2008 as the date for the commencement of trial in the ongoing patent infringement proceeding brought by VNUS Medical Technologies, Inc. against Diomed and its co-defendants, Angio-Dynamics, Inc. and Vascular Solutions, Inc. Diomed expects the trial to last up to four weeks.
"We are pleased that the court has selected a date for the trial," stated James A. Wylie, Diomed's President and Chief Executive Officer. "We are looking forward to establishing that Diomed does not infringe the VNUS patents, and that the VNUS patents are both invalid and unenforceable."

full article >> http://www.centredaily.com/business/technology/story/330974.html

Stanford researchers publish review of US medical device regulation

Report illuminates approval pathways impacting safety; innovation

WASHINGTON, D.C. – Researchers at the Stanford University Program in Biodesign have released a review of the background, mission and statutory requirements of medical device regulation in the United States. The report, published in the December 2007 issue of the Journal of Medical Devices, highlights the differences between regulations guiding medical devices versus pharmaceuticals and underscores the complexity of the approval process and post-market surveillance administered by the Food and Drug Administration (FDA).
According to the researchers, regulation plays a key role in the design, development and commercialization of new medical technologies, making a comprehensive understanding of the various regulatory requirements and their practical implementation a cornerstone of successful medical device innovation. The major barriers to moving innovative technologies from the bench to the bedside in the safest and most efficient way stem from the lack of precise scientifically based data about testing, regulatory approval and health-economic evaluation processes.
The review is part of an ongoing project at Stanford to examine how medical technology is brought to market, approved for use and subsequently enhanced over time. A key goal of the research is to build a model specific to medical technology that will be of value to current and future government initiatives aimed at enhancing the efficiency and efficacy of the regulatory process for public benefit.

full article >> http://www.eurekalert.org/pub_releases/2008-01/iti-srp011008.php

Medtronic Launches AneuRx AAAdvantage(R) Stent Graft on New Xcelerant(R) Hydro Delivery System in U.S. for Minimally Invasive Treatment of AAA

Hydrophilic Coating Designed to Aid Navigation of Device through Tight and Tortuous Arteries

MINNEAPOLIS--(HSMN NewsFeed)--Continuing its record of innovation in endovascular therapies for aortic aneurysms, Medtronic, Inc. (NYSE: MDT ), today announced the U.S. market launch of the AneuRx AAAdvantage® Stent Graft on the new Xcelerant® Hydro Delivery System, which features a hydrophilic coating designed to aid navigation of the device through tight and tortuous arteries by reducing friction with the artery wall. In addition, Medtronic has also received approval from the U.S. Food and Drug Administration to introduce its latest generation of packaging materials for the launch of this product.

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Interventional Radiology Treatment Could Decrease Hysterectomy Rate by One-Third

Fairfax, Virginia - Three-year data from the largest, multi-center, prospective voluntary registry on any procedure for benign uterine fibroids showed that 90 percent of the women participating avoided a hysterectomy and of these, 85 percent had a substantial improvement in symptoms and quality of life. The registry included three-year data on 1,278 patients from 26 sites who had this minimally invasive interventional radiology treatment for symptomatic fibroids, showing uterine fibroid embolization is a durable treatment for fibroids with sustained improvement in quality of life and symptom relief. Twenty to 40 percent of American women age 35 and older, and nearly 50 percent of pre-menopausal African American women, have uterine fibroids. Of the 600,000 hysterectomies performed annually in the United States, one-third of these are to relieve symptoms caused by fibroids. "This registry data is great news for women. With uterine fibroid embolization, we could significantly decrease the hysterectomy rate in the United States" says Scott Goodwin, MD, interventional radiologist and lead author.

read the full article >> http://www.dotmed.com/news/story/5321

BioCurex Licenses RECAF Technology to Inverness Medical Innovations

(PRIME NEWSWIRE) -- BioCurex (OTCBB:BOCX) and Inverness Medical Innovations (AMEX:IMA) have announced a licensing agreement for BioCurex's RECAF(tm) material and technology.
BioCurex is a biotechnology company with patented/proprietary technology identifying a cancer marker, RECAF. RECAF (the receptor for alpha-fetoprotein) is a wide-spectrum marker present in malignant cancer cells and absent in most normal cells, allowing it to play a major role in the development of new diagnostic tests for prostate, breast, colorectal, lung and other cancers. More than three years of testing by BioCurex has confirmed RECAF's high degree of clinical sensitivity and specificity in detecting various types of cancer, even when the disease is at its earliest stage.
Under terms of the license agreement, Inverness Medical Innovations will obtain semi-exclusive worldwide rights to commercialize products using this technology. BioCurex will be paid up-front fees, product and development milestones plus royalties on product sales.

full article >> http://www.primenewswire.com/newsroom/news.html?d=134018

Celsion Abstract Chosen for Oral Presentation in Award Session at IHPBA Congress in Mumbai, India

(BUSINESS WIRE) -- CELSION CORPORATION (AMEX: CLN: 2.83, -0.10, -3.41%) today announced that the company's ThermoDox liver cancer abstract, "Phase I Study of ThermoDox (Thermally Sensitive Liposomes Containing Doxorubicin) Given Prior to Radiofrequency Ablation for Unresectable Liver Cancers" has been selected for oral presentation in the Awards Session at the 8th Annual International Hepato-Pancreato-Bilary Association (IHPBA) Congress in Mumbai, India from February 27th to March 2nd. (http://www.ihpba2008.com/)
This Congress is hosted every two years at a different international location, with leading faculty and researchers invited from nearly 50 countries to provide global perspectives on the standard of care and latest treatment options for liver cancer. Of the over one thousand abstracts submitted to the Congress, only five percent were chosen for oral presentations in the Awards Session. The presentation will be made by Dr. Ronnie T. Poon, MD, Professor of Surgery, Faculty of Medicine at Queen Mary Hospital, University of Hong Kong.

full article >> http://www.foxbusiness.com/markets/industries/health-care/article/celsion-abstract-chosen-oral-presentation-award-session-ihpba-congress-mumbai_430519_10.html

December 2007 510(k) Approvals

Listed by date of approval:

Spectranetics: spectranetics quick-cross support2 cathe

PFM Medical: modification to: t-port hp infusion port

Cook Inc.: turbo-ject peripherally inserted central; advance 18lp pta dilatation catheter

AngioDynamics: smartport ct mp port access system and l

Smiths Medical: power port-a-cath, cath ii, and p.a.s. p

Merit Medical: merit medical systems, inc., guide wire

Bard Access: mri powerport implanted port with 9.6 fr

Vascular Solutions: pronto low profile (lp) extraction cathe

Vein RX: varicath peripheral infusion catheter

Medrad: medrad stellant ct injector system with

Medical Simulation Corporation and CardioSkills(C) Company Announce the Opening of a SimSuite(R)

DENVER, Jan. 8 /PRNewswire/ -- Medical Simulation Corporation (MSC) announces the opening of a SimSuite center in Germany. MSC has entered into an agreement with CardioSkills Company, headquartered in Frankfurt, Germany. MSCand the CardioSkills team have partnered to provide an interventional skills training experience for physicians and their staff through the use ofsimulation education. Training experiences range from basic to complex procedures.
press release >> http://www.reuters.com/article/pressRelease/idUS129622+08-Jan-2008+PRN20080108

Journal of Urology Supplement Focuses on Focal Therapy as a Prostate Cancer Treatment

IRVINE, Calif., Jan. 8 /PRNewswire-FirstCall/ -- Endocare, Inc. (Nasdaq: ENDO), 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 a Gold Supplement to the December edition of the journal Urology is focused on a series of 12 peer-reviewed studies on the use of focal therapy in the treatment of prostate cancer. The studies were conducted by a group of leading urologists and radiologists led by David Bostwick, M.D., a pathologist specializing in urology, and Gary Onik, M.D., an interventional radiologist, both of whom served as co-editors of the supplement. This is the first published scientific compendium dedicated solely to focal prostate cancer treatment. One of the leading focal treatment methods is cryoablation, or the minimally invasive freezing of the cancerous tumors to destroy them.

read the article >> http://www.streetinsider.com/Press+Releases/Journal+of+Urology+Supplement+Focuses+on+Focal+Therapy+as+a+Prostate+Cancer+Treatment/3247719.html

BSD Medical Receives Letter from FDA on BSD-2000 Submission

SALT LAKE CITY--(HSMN NewsFeed)--BSD Medical Corporation (AMEX:BSM ) today announced that it received a letter from the Food and Drug Administration (FDA) regarding its Premarket (PMA) submission for the BSD-2000 Hyperthermia System. The letter from the FDA provides guidance as to amendments needed to make the PMA approvable. The company is currently preparing its response to the amendments proposed by the FDA.
On July 31, 2007, BSD provided detailed answers to a significant number of questions from the FDA following its initial review of the BSD-2000 PMA submission. This letter is the only response to the submission that BSD has received from the FDA since it provided answers to the FDA’s questions in July.

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read more about Hyperthermia >> http://www.heatcancer.com/

Boston Scientific Completes Sale of Cardiac Surgery and Vascular Surgery Businesses

NATICK, Mass., Jan. 7 (HSMN NewsFeed) -- Boston Scientific Corporation (NYSE: BSX ) today announced that it has completed the sale of its Cardiac Surgery and Vascular Surgery businesses to the Getinge Group of Sweden for $750 million in cash. The sale follows the definitive agreement announced on November 5, 2007.

The Company expects to record after-tax charges of approximately $240 million in connection with the transaction. These charges will be recorded during the fourth quarter of 2007 and the first quarter of 2008."We have now sold three of our five previously identified non-strategic businesses, and we expect to close on the remaining two -- Fluid Management and Venous Access -- this quarter," said Jim Tobin, President and Chief Executive Officer of Boston Scientific.
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New dialysis provider forms, Reliant Renal Care Inc.

Reliant Renal Care, Inc. (RRC), a comprehensive outpatient dialysis provider, announces its company formation with the initial placement of $50 million in private equity for acquisitions and development.
Reliant Renal Care develops, acquires, and operates outpatient treatment centers for patients suffering from chronic kidney failure. Reliant Renal Care is a renal disease management company that affiliates with selected nephrology physician practices and hospital systems to develop health care delivery systems in markets throughout the United States.

read the full article >> http://www.nephronline.com/nephnews/index.php?option=com_content&task=view&id=1958&Itemid=131

CoolTouch Introduces CoolLipo(TM) Laser System, Recently FDA Cleared forLaser-Assisted Lipolysis

ROSEVILLE, Calif., Jan. 7 /PRNewswire/ -- CoolTouch Inc., a pioneeringmanufacturer of medical lasers, announced today that the CoolLipo(TM) 1320 nmlaser system received an additional 510(K) clearance from the U.S. Food and Drug Administration for laser lipolysis or melting fat. The CoolLipo 1320 laser is designed to ablate fat in areas such as the neck, chin and arms andimproves the outcome of conventional liposuction in larger areas such as the abdomen and thighs. In addition, the unique 1320 nm wavelength tightens theskin from the inside out by directly targeting collagen and connective tissue.The CoolLipo procedure is performed in a physician's office under local anesthesia. Patient benefits include minimal, if any bruising, and less recovery time and cost than a face or neck lift.
full article >> http://www.reuters.com/article/pressRelease/idUS68681+07-Jan-2008+PRN20080107

Cardica Receives $2 Million Payment From Cook Medical for Successful Completion of Multiple Milestones

Cardica Attains Fourth Milestone in Vascular Closure Device Collaboration Agreement and Completes Initial Development Milestone for Device to RepairHeart Defects -

REDWOOD CITY, Calif., Jan. 7 /PRNewswire-FirstCall/ -- Cardica, Inc.(Nasdaq: CRDC) today announced that it has received nearly $2 million inpayments from Cook Medical (Cook) for the achievement of significantmilestones pursuant to its development agreements with Cook. Cardica receivedthe fourth and final milestone payment of $500,000 for the delivery of theCook Vascular Closure Device (CVCD), an innovative automated system designedto close access openings in femoral arteries after interventional vascularprocedures. Cook also paid $1.3 million to Cardica for the successfulcompletion of the first phase of design and development of a specializeddevice designed to close holes in the heart known as patent foramen ovales(PFO), genetic heart defects.

press release >> http://www.reuters.com/article/pressRelease/idUS107166+07-Jan-2008+PRN20080107

Penumbra, Inc. Announces 510(k) Clearance of the Penumbra System(TM)

Device to Be Available for Immediate Commercialization; ClinicalData From 125 Patient Pivotal Trial to Be Released at the ASAInternational Stroke Conference in New Orleans on February 22, 2008

SAN LEANDRO, Calif.--(Business Wire)--Penumbra, Inc. today announced the 510(k) clearance by the US Foodand Drug Administration of the Penumbra System, which is indicated foruse in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease within 8hours of symptom onset. Penumbra will commence the immediatecommercialization of the device in the United States.

full article >> http://www.reuters.com/article/pressRelease/idUS94969+07-Jan-2008+BW20080107

DaVita and Phoenix-Based Southwest Kidney Institute Form Broad Partnership

El SEGUNDO, Calif., Jan. 4 /PRNewswire-FirstCall/ -- DaVita Inc. announced today that it and Southwest Kidney Institute, PLC ('SKI') have formed a wide-ranging partnership to provide dialysis and vascular access services, as well as chronic kidney disease education and research in the greater Phoenix area. The partnership will own and operate SKI's existing dialysis centers and programs designed to provide patients with access to all available treatment modalities. SKI's nephrology practice currently consists of 29 nephrologists in seven offices throughout greater Phoenix.

read the full article >> http://money.cnn.com/news/newsfeeds/articles/prnewswire/AQF00904012008-1.htm

Lawsuit filed on patent dispute

AngioDynamics accuses laser supplier of failing to defend Queensbury firm on appeal

ALBANY -- AngioDynamics Inc. is suing the supplier of laser technology used in some of its medical instruments, saying the company failed to defend the Queensbury manufacturer against patent-infringement suits brought by competitors challenging that technology.
Biolitec Inc. supplied the biolasers and laser fibers used in some of the products AngioDynamics marketed to treat varicose veins. In its supplier agreement, Longmeadow, Mass.-based Biolitec agreed to indemnify AngioDynamics and defend it against any patent claim, according to the suit filed Wednesday in U.S. District Court in Albany.
Biolitec did defend AngioDynamics in a lawsuit brought in 2004 by Diomed Holdings Inc. of Andover, Mass., but declined to continue that defense in an appeal after a judge ruled in Diomed's favor and awarded $8.36 million in damages, according to the filings. Biolitec also said it wouldn't cover that cost.
Biolitec also declined to defend AngioDynamics in a second patent infringement suit brought in 2005 by VNUS Technologies Inc. of San Jose, Calif., that is ongoing.

full article >> http://timesunion.com/AspStories/story.asp?storyID=652337&category=BUSINESS&newsdate=1/4/2008

Arrow Medical engineers new approach to Deep Vein Thrombosis

Arrow Medical Ltd has provided product development, production engineering services, assembly and distribution support to Medical Devices Technology International (MTDI) for the new Physio-Master, a self-inflating precision foot cushion that can reduce the risks of Deep Vein Thrombosis (DVT).The Physio-Master helps patients to replicate the action of walking, to benefit blood circulation and also aids rehabilitation of lower limb circulatory problems, such as lymphoedema and swollen ankles. It can also help patients with balance problems by supporting improvements in pro-prioception, which, while assisting the elderly and other patients recovering after injury, also helps athletes improve reaction times.

press release >> http://www.sourcewire.com/releases/rel_display.php?relid=35974&hilite=

FDA Marketing Clearance for the "Vicorder" New Portable Device to Detect Peripheral Vascular Disease

Jan 2, 2008--(HSMN NewsFeed)--PHYSICIANS Resource Network, Inc today announced the FDA has granted 510(k) marketing clearance for the Vicorder manufactured by Skidmore Medical. The Vicorder is a new USB driven vascular diagnostic system which utilizes proprietary software within a Windows operating system to provide Hospitals and Vascular labs a cost-efficient method to diagnose peripheral vascular disease.

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VIBRANT Study of GORE VIABAHN Endoprosthesis Completes Enrollment

FLAGSTAFF, Ariz.--(BUSINESS WIRE)--Jan 2, 2008 - W. L. Gore & Associates (Gore) today announced that it has completed patient enrollment in the Gore VIBRANT (GORE VIABAHN Endoprosthesis veRsus bAre Nitinol stenT) Study of comparative treatments for peripheral vascular disease (PVD) of the superficial femoral artery (SFA). The Gore VIBRANT Study is a randomized, prospective, multi-center clinical trial intended to demonstrate patency superiority in the treatment of lesions eight cm or longer with the GORE VIABAHN(R) Endoprosthesis compared to bare nitinol stents. The study enrolled 150 participants at 15 study sites over the course of three years, with patency surveillance via duplex ultrasound at one-, six-, 12-, 24- and 36-month intervals.
full article >> http://www.pharmalive.com/News/index.cfm?articleid=503071&categoryid=21

BioSphere: New data shows efficacy, durability of uterine fibroid embolization

SAN FRANCISCO, Jan. 2, 2008 (Thomson Financial delivered by Newstex) -- BioSphere Medical Inc. (NASDAQ:BSMD) said Wednesday that new, three-year data demonstrated that uterine fibroid embolization produced a high level of durable long-term symptom control and resulted in a 'significant improvement' in a woman's health-related quality of life.'Three-year data from the largest, multi-center, prospective voluntary registry on any procedure for benign uterine fibroids showed that 90% of the women participating avoided a hysterectomy, and of these, 85% had a substantial improvement in symptoms and quality of life,' the Society of Interventional Radiology said in a statement.The data is from the Fibroid Registry published in the January 2008 issue of Obstetrics & Gynecology, BioSphere said.The study was funded through the Society for Interventional Radiology Foundation and, in part, from BioSphere, the company noted.

full article >> http://money.cnn.com/news/newsfeeds/articles/newstex/AFX-0013-21990628.htm

Varian Medical Systems Receives FDA 510(k) Clearance for RapidArc(TM) Radiotherapy Technology

Groundbreaking technology delivers faster, more precise cancer treatments using a unique form of volumetric arc therapy

PALO ALTO, Calif., Jan. 2 (HSMN NewsFeed) -- Varian Medical Systems (NYSE: VAR ) has received FDA 510(k) clearances for its RapidArc(TM) radiotherapy technology, a revolutionary advance that makes it possible to deliver image-guided, intensity-modulated radiation therapy (IMRT) two to eight times faster and more precisely than is possible with conventional IMRT or helical tomotherapy.
"RapidArc represents a major medical advance that will change the way radiation therapy is planned and delivered," says Dow Wilson, president of Varian's Oncology Systems business. "Our primary goal with this product is to improve clinical outcomes. In addition, we discovered that we could simultaneously improve treatment efficiency significantly. RapidArc should make better-quality radiotherapy a more affordable, more accessible treatment option, and enable more cancer patients to receive a higher standard of care."

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