A pending article in the New England Journal of Medicine, whose results were released yesterday at the American College of Cardiology meeting, concludes what some have suspected: Most patients who undergo angioplasty don't need it. The study found that angioplasty did not save lives or prevent heart attacks in non-emergency heart patients, reports the Associated Press. This has never been claimed, but it has often been assumed by doctors and patients. More stunning is that angioplasty gave only slight and temporary relief from chest pain, which is the main reason the procedure is performed. Drugs are just as effective, and 2/3 of the patients who tried drug therapy first did not need angioplasty or bypass surgery later, the study found. The findings could drastically reduce the number of angioplasties performed -- many of which also result in stents being implanted. The debate may shift from what...
March 27th, 2007
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Abbott's Xience drug-eluting stent outperformed Boston Scientific's Taxus for keeping blood vessels open, according to a study presented at the American College of Cardiology meeting over the weekend, reports Bloomberg News. Xience also showed that it could significantly reduce major cardiovascular complications, a trait not seen in previous DES trials. Abbott also reported that the first human trial of its bioabsorbable stent has gone well. For Boston Scientific's part, it reported that Taxus outperformed brachytherapy in treatment of in-stent restenosis. Xience is likely to get FDA approval in early 2008 and is expected to garner 30% of the market or more. The only reason Abbott has the technology, originally developed by Guidant, is that Boston Scientific had to sell off Guidant's stent business to satisfy antitrust concerns when buying Guidant. Wouldn't it be...
March 26th, 2007
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Transforming FDA LogoIn the fall, FDA and Health Canada launched a pilot program allowing authorized third-party inspectors to cover US and Canadian requirements in a single inspection. It was viewed as a step toward eventually having a single authority inspect for worldwide requirements, which industry has said it wants. So how many U.S. firms have expressed interest in taking advantage of the program so far? One. This was reported by Larry Kessler, director of CDRH's Office of Science and Engineering Laboratories and chair of the Global Harmonization Task Force, at this week's AAMI/FDA International Conference on Medical Device Standards and Regulation. Kessler said that CRDH obtained a list from Health...
March 23rd, 2007
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Transforming FDA LogoExperts who advise FDA on the approval of a medical device or drug could soon be facing much tougher rules. In efforts to further limit conflicts of interest, FDA's new draft guidance proposes stringent guidelines for advisory committee members and those who want to participate in meetings regarding the approval of a device or drug. Potential participants will no longer be able to advise on a product if they have related financial interests exceeding $50,000. These include interests in the company whose product is being discussed or one of its competitors. A person who has interests $50,000 or less can apply for an...
March 22nd, 2007
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FDA has approved what St. Jude Medical (St. Paul, MN) calls the first U.S. heart failure device to suppress atrial fibrillation (AF). The device, called the Atlas II + HF cardiac resynchronization therapy defibrillator, has a special algorithm that helps control the heart's atrial rhythm. It does this by pacing slightly faster than the patient's natural heart rate, according to the company. Nearly 5 million Americans experience heart failure and about 40% of patients who have heart failure also have AF, cites St. Jude in a news release.
March 21st, 2007
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British authorities have issued a safety alert about a potential malfunction in implantable cardioverter-defibrillators made by Guidant, now owned by Boston Scientific, reports the Star Tribune of Minneapolis. The U.K.'s Medicines and Healthcare Products Regulatory Agency issued two advisories, one concerning potential delays in shocks and one concerning an erroneous signal that the battery is nearing the end of its life. No deaths have been reported but 31 devices have been prematurely removed from patients. FDA has not issued a similar warning in this country. While the news may not necessarily indicate that manufacturing problems are still pervasive for the Guidant devices, some doctors could take it that way. At home, FDA announced a Class I recall by HoMedics, Inc. (Commerce Twp., MI) of five heating-pad models that may short-circuit, causing...
March 20th, 2007
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Transforming FDA LogoFDA and industry know what they want out of MDUFMA II, as negotiations are just about complete. The stumbling block, however, is Congress. Congressional Democrats are unhappy with the pharmaceutical industry, and the device industry could get caught up in their wrath, TheHill.com reported in a feature last week. Congressional Democrats want to tie reauthorization of the pharmaceutical user-fee program to new drug safety requirements. MDUFMA is likely to be bundled with the pharma bill, which could lead to delays in its reauthorization as the pharma battle...
March 19th, 2007
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An article in today's edition of the New York Times is further evidence of the increased scrutiny that the medical device industry has been facing in recent times. The piece questions how device companies react to product malfunction and how they're perhaps not moving fast enough to pull these devices from the market. It also ties the failure to recall a product with the inability to properly track and analyze device-related complaints. In the advent of FDA's Postmarket Transformation Initiative and recent highly publicized recalls, companies need to make sure they have efficient and effective device tracking systems in place. The article in the Times cites the delay in the recall of a hernia patch, manufactured by Davol Inc., a subsidary of C.R. Bard. In this instance, Davol failed to "accurately" report the potential severity of the device complaints to FDA, and agency inspectors found "...
March 16th, 2007
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Are you part of a first-rate quality and/or regulatory team? Do you work with one? If so, why not give the team a chance for some recognition? Nominate the team today for MD...
March 15th, 2007
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Janet Moore gets it. It is all too common for industry to be completely left out of mainstream media pieces on medical innovations. Such stories often focus on the doctor and patient perspective and don't mention that without a company's R...
March 14th, 2007
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