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Boston Scientific Joins Carotid Stent Fray Acquisition of Endotex Puts NexStent® into Company's Device Portfolio |
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January 4, 2007 -- Boston Scientific today announced acquisition of Endotex, a Silicon Valley device start-up that in November received FDA approval for its NexStent carotid stent. Financial details of the acquisition were not disclosed, but Boston Scientific has been a stakeholder in Endotex since 2001, and in 2003 extended its investment with an option to acquire the company, if certain regulatory milestones were reached. By acquiring a previously-approved device, Boston Scientific now has an FDA-sanctioned carotid stent system, even though the company is still operating under a year-old FDA warning letter, which placed a hold on "Class III" device approvals. Carotid stents are considered Class III devices. Recent studies have generated some controversy over whether stenting or surgery offers the best treatment option for carotid blockages, but three device manufacturers, Abbott, Johnson & Johnson/Cordis and Boston Scientific, are now positioned to pursue the carotid stent market. (Medtronic's Exponent® RX stent and Interceptor® PLUS filter system has received CE Mark approval in Europe and a late 2007 FDA approval is a possibility.) The NexStent is the fourth carotid stent approved for use by the FDA. Carotid stenting systems comprise two actual devices: the stent itself and a separate but compatible filter, which helps prevent emboli that may be dislodged during stent placement from traveling upstream into the brain, causing a stroke. Guidant's Acculink™/Accunet™ combination was the first carotid stent, approved in August 2004. Next was Abbott's Xact® Carotid Stent and Emboshield® Embolic Protection System, approved in September 2005. Shortly thereafter, Guidant's vascular division, along with the Acculink, was sold off to Abbott, as part of the Boston Scientific-Guidant acquisition agreement. So, for the next 9 months, Abbott manufactured and marketed both of the two approved carotid stents in the U.S. That changed In September 2006, when the FDA approved the third carotid device: Cordis' PRECISE® Nitinol Stent and ANGIOGUARD® Emboli Capture Guidewire. (The Cordis stent actually had been recommended for approval by the FDA Circulatory Devices Panel in early 2004, but had been "on hold" for two-and-a-half years while manufacturing and other issues were addressed.) Less than two months later, approval was granted to Endotex for the NexStent. The NexStent is a self-sizing carotid stent made of Nitinol and has been studied as part of the CABERNET trial, along with its companion embolic protection filter, Boston Scientific's FilterWire EZ™. The device-centric procedure of Carotid Artery Stenting (CAS) opens the main arteries in the neck that supply the brain. CAS competes primarily with the open surgical operation known as carotid artery endarterectomy (CAE) -- one of the most often-performed vascular surgical procedures. Several studies have shown equivalence between the two methods for certain patients, although some smaller and controversial European studies recently demonstrated significantly better results for the surgical procedure. The CREST Trial is currently underway and is hoped to be the definitive answer to whether stenting and surgery are equivalent. Because of reimbursement restrictions, the market for carotid stents is relatively small, but is growing, due in part to patients who want to avoid surgery by opting for the minimally-invasive stent instead. As Abbott Vascular President Chip Hance said during a webcast last year, if the current CREST and ACT I clinical trials show results, carotid stenting could become a billion dollar a year business in a very short time.
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