January 2008 - Medical Device News

Ascension Orthopedics Closes $21 Million Financing

Ascension Orthopedics, Inc., an emerging medical device company that develops, manufactures and markets joint replacement, trauma and tissue regeneration surgical implants for use in upper and lower extremities, announced today that it has secured $21 million in a Series D financing. This new round of funding will be used primarily to expand the current product line and enhance the Company's product marketing and distribution network.

Leading this Series D financing as the majority investor is Frazier Healthcare Ventures, one of the nation's leading providers of venture and growth equity capital to emerging healthcare companies. Alan Frazier, General Partner and Founder of Frazier Healthcare Ventures will join Trevor Moody, General Partner of Frazier Healthcare, and Steven Tallman, Venture Partner of Frazier Healthcare on Ascension's Board of Directors. Full Article.

Stryker responds to recent FDA warning letter, recalls certain acetabular cups

Stryker has initiated a voluntary recall of its Trident PSL and Hemispherical Acetabular Cups manufactured in its Cork, Ireland, facility, the company announced.

The action follows an internal investigation that Stryker conducted into a deviation from its internal specifications and processes for manufacturing the devices at the facility. The investigation found that all Trident Acetabular products manufactured at the facility did meet all U.S. and international performance standards for sterility and biocompatibility. However, results from that testing indicated that the level of manufacturing residuals in some cases exceeded the company's internal acceptance criteria, according to a press release from Stryker. Full article.

Boston Scientific Announces CE Mark Approval For New Devices To Treat Heart Failure And Sudden Cardiac Death
Boston Scientific Corporation (NYSE: BSX) announced CE Mark approval for its COGNIS(TM) cardiac resynchronization therapy defibrillator (CRT-D) and TELIGEN(TM) implantable cardioverter defibrillator (ICD). These devices represent entirely new platforms to treat heart failure and sudden cardiac death and are the result of a multi-year research and development effort to provide physicians enhanced clinical options for their patients.

When choosing a high-energy device, physicians often must make trade-offs among device size, battery longevity and features. The COGNIS CRT-D and the TELIGEN ICD are designed to eliminate those compromises. Full article.

Scientists 'Grow' Hearts
"Scientists have grown a whole beating heart in the laboratory, bringing the goal of growing replacement organs for humans a step closer", The Guardian reported yesterday. Many of the major newspapers reported on the development of the "first bioartificial heart". Most focus on the idea that developing organs in the laboratory may signal an end to a shortage of replacement tissues for people requiring heart transplants. They go on to suggest that the technology could be applied to other organs. Full Article.