He has done some groundbreaking work in microfluidics, which led to a patent and a strong outlook for the fledgling company, which is projected to generate $30 million in revenue over the next five years. It's important that young, innovative companies get recognition when they succeed; they need all they can get to keep them going.
The researchers conclude that there is "a small but real hazard of late stent thrombosis with drug-eluting stents." The findings, published in the December issue of the American Journal of Medicine, are sure to make next week's meeting of CDRH's Circulatory System Devices Panel even more interesting. The meeting, scheduled for Dec. 7-8, could produce some consensus among FDA and doctors about the safety issues related to drug-eluting stents. It could go a long way toward determining future levels of use in the United States. Industry has a lot at stake here.
But a federal judge sided with plaintiff lawyers, who argued that Medtronic had known about the faulty batteries for two years before reporting the problem to FDA. No deaths or injuries have been reported as a result of the problem. Medtronic is likely to appeal the decision. UPDATE: On Wednesday night, the Star-Tribune published a story speculating that out-of-court settlements could be in the cards.
The Watchman seals off that flap, depriving clots of their staging area. Whether it prevents strokes is yet to be seen, but early results are encouraging. What's not encouraging is that the AP made no mention of the company that developed the device, Atritech, Inc. of Plymouth, MN.
Contributing on the diagnostics side is Phillips, which is expected to provide computed tomography equipment to scan the hearts and arteries of the 4,000 to 6,000 patients in the project. On the device side, Abbott has a separate 700-patient study on this topic, inherited from Guidant when it bought that firm's stent operations. It's not clear what these studies might yield and whether devices can be of help to whatever is learned. But it's important they proceed.
Cook's abdominal aortic aneurysm (AAA) stent graft, Zenith, is a strong competitor in the endovascular sector and was recently launched in Japan (it's also is the first and only such device there). And out of the 6200 AAA stent grafts implanted in the United States in the third quarter, the Zenith endograft came in second with 37% of the market, behind Gore's graft by a mere 1%. However, during the same quarter in Europe, Zenith was at the top with 47% of the market and a 15% lead. Cook's endovascular unit has also expanded in Japan, Taiwan, and South America, and is positioned in what Thomas labeled the "emerging" markets of China, India, and Korea. The division is also keeping endovascular disorders such as disease in the ascending aorta and thoraco-abdominal disease on its radar screen for future device development.
Meanwhile, with contacts, the longer they are in use, the greater the chance of a problem from leaving them in too long or failing to follow cleaning procedures.
Cyberonics CEO Robert "Skip" Cummins is also leaving his post, but under less auspicious circumstances. He had come under fire for the timing of a stock-option grant he received in 2004. Cyberonics' board granted him 100,000 shares just hours after FDA approved the company's implant to treat depression, and the value of the shares soared the next morning. CFO Pamela Westbrook also resigned. Some analysts speculate that Cummins' departure clears the way for Cyberonics to be sold, as rivals Advanced Neuromodulation Systems and Advanced Bionics have been in recent years.
They are prone to rupture, however, and CDRH Director Daniel Schultz advises potential users to keep that in mind. Upfront disclosure of potential issues, continued disallowal of their use for cosmetic reasons for women under 22, and mandated postmarket studies by manufacturers Allergan and Mentor should be enough to assure that the implants are used as safely and effectively as possible. Consumers should remain vigilant, however, and FDA has given them a head start by providing a list of useful information about the Allergan and Mentor products. Part of FDA's job is to keep patently unsafe products off the market. But that does not extend to banning any product that might present some risks, as there is no such thing as a zero-risk medical device. As long as the science shows that silicone implants are not patently unsafe, and that research will continue to occur, it's best to let consumers decide for themselves.
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In order to help engineers save time in designing products, a drive and control technology company has incorporated a tools and downloads section onto its Web site. Bosch Rexroth Corp. (Hoffman Estates, IL) provides resources focusing on electric drive and control, pneumatic, linear motion, and assembly technologies. A range of CAD files are accessible from the page, as are aluminum framing profile-deflection and pneumatic calculation tools. Additional features include a number of configurators, an aluminum framing shop, and product literature. Software information for such programs as FMSsoft, IndraSize, Industrial Digital Controller Product Installer, and RDwin are also offered.
