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Guidant releases product information

INDIANAPOLIS – Under fire for recalling thousands of its pacemakers and defibrillators, Guidant Corp. released a massive product report card Wednesday in an effort to allay concerns about its implantable devices.The 153-page document includes product-by-product lists that detail the longevity and failure rates for heart devices made by the Indianapolis-based company.The report came two days after Guidant said its third-quarter earnings dropped 57 percent because of months of safety advisories and recalls that sent its stock price spiraling and put its acquisition by Johnson & Johnson in jeopardy.”This is related to the folks out there that are customers asking for more information,” said Renold Russie, Guidant’s director of product performance reporting. “It certainly provides a window into our quality system. Anybody can take a look at what we’re seeing, and we think that will be confidence building.”For years, the medical device industry has tracked its products, but Guidant’s report is the among the first to include details such as the number of devices that remain implanted in patients, failure information and whether those failures compromised patient therapy.”Trust in Guidant, for the time being, has declined,” said Samin K. Sharma, a cardiologist with Mt. Sinai Medical Center in New York. “The report that has come out is a very good practice for them.”Russie said the report will be updated quarterly. Separate versions written in patient-friendly language and highlighting an individual product may also be offered.Guidant’s recalls, along with warnings from its competitors, have focused attention on the lack of standards for disclosing problems with medical devices to patients and doctors.Anne B. Curtis, president of the Heart Rhythm Society and chief of cardiology at the University of South Florida, said Guidant’s report will likely help restore credibility to medical device manufacturers.”I think it is going to be necessary that we have this very above board disclosure,” she said. “I think everybody will have to be doing this thing where there’s a very detailed and very public disclosure about what to expect from each of their devices.”The Heart Rhythm Society and an independent Guidant panel are working to propose recommendations about when medical device companies should disclose problems with their products.Since June, Guidant has recalled or issued warnings about 88,000 heart defibrillators – including its top seller, the Contak Renewal 3 – and almost 200,000 pacemakers because of reported malfunctions. Pacemakers use mild electrical current to speed a slow heartbeat; defibrillators use a bigger jolt to correct life-threatening irregular heartbeats.The company acknowledged it waited years to alert physicians about some problems and now faces multiple lawsuits as well as regulatory investigations.John Putnam, an analyst with Stanford Group Co., said releasing information such as Wednesday’s report could help the company rebound. Putnam upgraded his rating of the company’s stock to buy.”They’ll probably stabilize their market share with these press releases and information dumps,” he said. “They will pull themselves together and they will move forward and they will dress themselves up and they will become an acquisition candidate again.”Guidant is suing New Brunswick, N.J.-based J&J to force it to complete its $25.4 billion acquisition of the heart device maker.The deal was announced in December and received federal regulatory approval last week. But J&J officials have said they aren’t obligated to follow through the $76-per-share deal because of Guidant’s device problems.Guidant shares rose 26 cents to close at $56.79 in trading on the New York Stock Exchange, then fell 14 cents in after hours trading. J&J stock rose 25 cents to $61.02.Vail, Colorado


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