Healthcare Industry News: stent thrombosis
News Release - October 23, 2006
Boston Scientific to Support Landmark STENT Thrombosis StudyMulti-center registry to enroll 10,000 patients over two years
NATICK, Mass. and WASHINGTON, Oct. 23 (HSMN NewsFeed) -- Boston Scientific Corporation (NYSE: BSX ) today announced that it intends to provide lead financial support for an extension of the STENT drug-eluting stent registry to study the effects of late stent thrombosis in drug-eluting stents. The STENT (Strategic Transcatheter Evaluation of New Therapies) registry is the largest prospective, comparative real-world drug-eluting stent (DES) study ever reported in the U.S. It was initiated in 2003 to evaluate the long-term efficacy and safety of paclitaxel-eluting and sirolimus-eluting coronary stents among real-world patients and clinical situations. With this agreement, Boston Scientific will support extension of that study to include the examination of stent thrombosis. The Company made the announcement at the Cardiac Research Foundation's (CRF) eighteenth annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in Washington, D.C.
The stent thrombosis Study will be sponsored by Dr. Charles Simonton of the Carolinas Heart Institute, Charlotte, NC, and Dr. Gregg Stone of the Cardiovascular Research Foundation in New York. Approximately 10,000 new patients undergoing DES implantation will be enrolled in the second phase of this prospective registry, using a process similar to that used in the STENT registry previously conducted by Dr. Simonton and his colleagues. The existing STENT registry has already enrolled over 20,000 patients. Enrollment of patients in the stent thrombosis Study would begin in early 2007 and would be completed within 12 - 18 months.
"Late stent thrombosis is a rare event that occurs in DES technologies and this registry will further our efforts to better understand the risk factors for the early and the late stent thrombosis phenomena," said Dr. Simonton, chairman of the executive steering committee for the STENT Registry.
"This significant new study will examine clinical, drug-related and other possible contributors to stent thrombosis in the two commercially available stents in the U.S.," said Dr. Donald S. Baim, Chief Medical and Scientific Officer for Boston Scientific. "Boston Scientific is delighted to support this effort to help physicians better understand the risk factors for this infrequent but potentially serious complication of stenting."
Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. For more information, please visit: http://www.bostonscientific.com.
This press release contains forward-looking statements. Boston Scientific wishes to caution the reader of this press release that actual results may differ from those discussed in the forward-looking statements and may be adversely affected by, among other things, risks associated with new product development and commercialization, clinical trials, intellectual property, regulatory approvals, competitive offerings, integration of acquired companies, Boston Scientific's overall business strategy, and other factors described in Boston Scientific's filings with the Securities and Exchange Commission.
Source: Boston Scientific
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