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NewLink Genetics receives FDA SPA approval for HyperAcute immunotherapy Phase 3 pancreatic cancer trial

NewLink Genetics Corporation announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) process for a pivotal Phase 3 trial of its HyperAcute immunotherapy in pancreatic cancer. Pancreatic cancer is highly lethal and is currently an area of very significant unmet medical need. The SPA is a written agreement between NewLink as the trial sponsor and the FDA regarding the design, endpoints, and planned statistical analysis of a Phase 3 trial to be used in support of a Biologic License Application (BLA).

12 Feb 2010

Quebec transplantation: 431 people receive 499 organs from 138 deceased donors

Owing to the generosity of Quebecers, 499 organs from 138 deceased donors in 2009 were transplanted into 431 recipients. Though there were 13 fewer donors than in 2008, Québec posted an average of more than 3.6 transplanted organs per deceased donor in 2009, placing the province among the leaders in Canada and even North America. "We're particularly proud of the sustained collaboration of professionals in hospitals in 2009," says Louis Beaulieu, chief executive officer of Québec-Transplant, the organization responsible for coordinating the organ donation process.

11 Feb 2010

Bard FLAIR Endovascular Stent Graft more effective than balloon angioplasty for failing dialysis grafts

C. R. Bard, Inc. today announced the publication of trial results by The New England Journal of Medicine (NEJM) showing the Bard FLAIR® Endovascular Stent Graft maintains the patency of dialysis access grafts more effectively than balloon angioplasty alone. The FLAIR® Endovascular Stent Graft is the only implant approved by the U.S. Food and Drug Administration for use in the treatment of stenoses at the venous anastomosis of ePTFE or other synthetic arteriovenous access grafts.

11 Feb 2010

Boston Scientific rebuts HeartRhythm's cardiac resynchronization therapy defibrillator implantation article

Boston Scientific Corporation today rebutted an article published in the journal HeartRhythm. The article reported a case summary of a patient who had been implanted subcutaneously with a Cognis cardiac resynchronization therapy defibrillator. The article suggested a weakened header bond was responsible for the abnormal sensing and pacing impedance experienced by the patient.

11 Feb 2010

SafeStitch Medical's AMID Stapler receives European CE Mark

SafeStitch Medical, Inc. announced today that it has received CE Mark authorization to commercialize its AMID StaplerTM in the European Economic Community. The new stapler is to be used for fixation of mesh in the repair of hernia defects and also for the approximation of tissues, including skin. The AMID Stapler™ is the first surgical stapler designed specifically for use in inguinal hernia repairs using the Lichtenstein method, in which mesh is implanted for reinforcement. SafeStitch announced in November 2009 that it had received 510(k) clearance from the Food and Drug Administration for sale of the AMID StaplerTM in the U.S. market.

10 Feb 2010

Breast enhancement surgery: Pros, cons and options

With ever growing cases of breast enlargement surgery in the UK, CosmeticSurgeryGuru can report that patients interested in undergoing breast enhancement surgery in 2010 continue to make the choice between saline and silicone implants. CosmeticSurgeyGuru notes that in 2009 breast enhancements remained the most popular procedure for women in the UK.

10 Feb 2010

Obese adolescents who receive laparoscopic adjustable gastric banding lose excess weight

A higher percentage of severely obese adolescents who received laparoscopic adjustable gastric banding lost more than 50 percent of excess weight and experienced greater benefits to health and quality of life compared to those in an intensive lifestyle management program, according to a study in the February 10 issue of JAMA.

10 Feb 2010

FoP in patients with chronic arthritis or cancer: Group psychotherapy may help

A controlled study by a group of German investigators published in the current issue of Psychotherapy and Psychosomatics indicates that brief group psychotherapy is helpful for clearing fears of disease progression (FoP) in patients with chronic arthritis or cancer. The interventions comprised either cognitive-behavioral group therapy or supportive-experiential group therapy. The investigators tested whether these generic interventions would prove effective in different illness types.

10 Feb 2010

FDA announces initiative to reduce cancer risk from medical imaging procedures

The U.S. Food and Drug Administration today announced an initiative to reduce unnecessary radiation exposure from three types of medical imaging procedures: computed tomography (CT), nuclear medicine studies, and fluoroscopy.

10 Feb 2010

FDA grants marketing clearance for Volcano's Eagle Eye Platinum digital IVUS catheter

Volcano Corporation, a leading developer and manufacturer of precision intravascular therapy guidance tools designed to enhance the diagnosis and treatment of coronary and peripheral vascular disease, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the Eagle Eye® Platinum digital IVUS catheter in the United States.

9 Feb 2010

Surgical 'checklist' saves money, lives

The Newshour has a transcript of a feature report on Dr. Atul Gawande's new book, "The Checklist Manifesto: How to Get Things Right," which "grew out of work he did for the World Health Organization, which asked him to help them find a way to reduce deaths in surgery."

9 Feb 2010

Cynosure settles patent infringement lawsuit against CoolTouch

Cynosure, Inc., developer of the award-winning Smartlipo™ LaserBodySculpting(SM) procedure for minimally invasive removal of fat, and its largest shareholder, El.En. S.p.A, today announced a settlement of their patent infringement lawsuit against CoolTouch, Inc. Cynosure and El.En. alleged that CoolTouch's 1320 nm CoolLipo™ laser system infringed on El.En.'s U.S. Patent No. 6,206,873 (the 873 patent) licensed to Cynosure, which covers laser technology to remove subcutaneous fat.

9 Feb 2010

FlowCardia commences enrollment in CROSSER CTO Recanalization Catheter study

FlowCardia, Inc., a worldwide leader in the development of endovascular devices for the treatment of chronic total occlusions (CTOs), today announced Dr. John Paul Runyon from The Christ Hospital in Cincinnati, Ohio successfully enrolled the first patient into the CENTRAL (Crosser ENters The Right Arterial Lumen) study.

9 Feb 2010

SANUWAVE Health’s dermaPACE device effective in treating severe burns

SANUWAVE Health, Inc.,, an emerging medical technology company focused on regenerative medicine, announced that a European scientific study reporting the successful treatment of severe burns using the dermaPACE® device has been published by BURNS, the Journal of the International Society for Burn Injuries.

9 Feb 2010

Innovative nerve graft transplant successful in treatment and prevention of posterior pressure ulcers

The Plastic Surgery Center today announced that an innovative nerve graft transplant performed by Dr. Andrew Elkwood has proven to be successful in treating and preventing posterior pressure ulcers – one of the leading causes of mortality among paraplegics. 49-year old Tory Cavalieri, who underwent the procedure last January, has regained sensation in his posterior and is free of acute pressure sores, which had left him bedridden for years.

9 Feb 2010

Gastric banding surgery offers fewer complications, but more research needed

Laparoscopic adjustable gastric banding surgery can effectively treat obesity in adolescents and seems to offer a better alternative than gastric bypass surgery, but further study is needed to determine whether it's better than nonsurgical options, a UT Southwestern Medical Center surgeon writes in an editorial in the Feb. 10 issue of the Journal of the American Medical Association.

9 Feb 2010

New revolutionary treatment for patients suffering from movement disorders

Deep Brain Stimulation (DBS), a new treatment being offered at Geisinger Medical Center (GMC) and Geisinger Wyoming Valley Medical Center (GWV), can dramatically reduce symptoms of movement disorders.

9 Feb 2010

Synovis Life Technologies' Flow Coupler receives FDA marketing approval

Synovis Life Technologies, Inc., has received Food and Drug Administration 510(k) marketing clearance for its Flow Coupler®, an innovative extension of the company’s well-established Microvascular Anastomotic Coupler used in several surgical procedures to connect small blood vessels more quickly and with equal or greater reliability than hand suturing. The Flow Coupler incorporates Doppler technology to immediately measure blood flow after connecting the small blood vessels.

9 Feb 2010

Stereotaxis Magnetic Navigation System installed at CHMC, Taiwan

Stereotaxis today announced the installation of its first Stereotaxis Magnetic Navigation System in Taiwan at Cheng-Hsin General Hospital (CHMC) located in Taipei. CHMC hosted a Grand Opening event on January 26 that received wide coverage throughout the area and, to date, ten procedures have been successfully performed using Stereotaxis at the hospital.

8 Feb 2010

Breast cancer: Lower dose of radiotherapy in fewer, larger doses as effective as higher total dose

The chronic side-effects of radiotherapy for early breast cancer, as reported by women themselves, are not any worse when treatment is given in a lower overall dose in fewer but larger treatments according to a trial part funded by Cancer Research UK and published today in the Lancet Oncology.

8 Feb 2010