Medical Device Link.

Apart from the damage to Guidant’s prestige and reputation as a premier manufacturer of innovative medical devices, industry analysts have begun to speculate about potential effects on the company’s pending $25.4 billion acquisition by Johnson & Johnson Inc. (J&J; New Brunswick, NJ). When Guidant’s ICD problems were first disclosed, J&J issued a press release stating that it expected the deal to close on schedule. The world’s largest medical device maker has reportedly been in close consultation with Guidant regarding the ICD issue, but has had no further public comment. Meanwhile, industry analysts increasingly appear to believe that J&J may want to revisit the terms of the deal.
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Watching the latest court rulings in the coronary-stent patent infringement suits brought by Boston Scientific Corp. (Natick, MA) and Cordis Corp. (Miami Lakes, FL), a Johnson & Johnson company, is a little like watching a tennis match with no end. In mid-June, the U.S. district court in Wilmington, DE, found that Boston Scientific’s Taxus drug-eluting stent and two of the company’s bare-metal stent platforms—the Taxus Express and its next-generation counterpart, Liberté —infringe on patents held by Cordis. But just nine days after the jury verdict in its favor, Cordis found itself on the losing end of a decision from the same Delaware court. The court ruled that the company’s Cypher drug-eluting stent infringes on Boston Scientific’s drug-coating technology patent. The court also ruled that Cypher and Cordis’s Bx Velocity, Bx Sonic, and Genesis stents violate Boston Scientific’s stent-d esign patents.

Winners of the inaugural Biomedical Engineering Innovation Design and Entrepreneurship Awards (BMEidea) competition—a new showcase competition for students involved in developing medical products—were announced during the recent Medical Design Excellence Awards ceremony in New York City. The BMEidea competition recognizes excellence in student biomedical innovation. Winning teams at this year’s competition were selected from a pool of entries submitted by some of the nation’s top biomedical engineering departments, and were judged by a panel of experts in medicine, engineering, patent law, and business.

 Accepting the inaugural BMEidea
 awards on behalf of their teams (from
 left): Elizabeth Tran (Washington
 University, St. Louis), Ashkon
 Shaahinfar (Johns Hopkins University,
 Baltimore), and Amy Lee (Stanford
 University; Palo Alto, CA).

In one of recent times’ most closely watched and widely reported decisions in the medical device regulatory approval process, FDA’s circulatory system devices panel ruled against granting a humanitarian device exemption (HDE) for the AbioCor artificial heart by Abiomed Inc. (Danvers, MA). Although the panel voted against recommending a “not approvable” determination, a subsequent motion asserting that the AbioCor device does not meet the requirements of an HDE passed with a vote of 7–6, with one abstention. Abiomed chairman, president, and CEO Michael R. Minogue said, “While we are disappointed in the panel's recommendation, there is more work to be done to clarify our submission and HDE requirements.” [ More ]