NATICK, Mass., July 17 /PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE: BSX) today announced the successful implantation of the Company's TAXUS® Petal™ Bifurcation Paclitaxel-Eluting Stent System (TAXUS Petal Stent) in a patient in New Zealand, marking the beginning of the TAXUS PETAL I First Human Use (FHU) Trial. The trial is designed to evaluate the safety of a dedicated bifurcation paclitaxel-eluting stent platform for the treatment of coronary artery disease. The procedure was performed by John Ormiston, M.D., at Auckland City Hospital in Auckland, New Zealand.
A significant percentage of coronary artery disease -- as much as 30 percent -- occurs at a bifurcation, where one artery branches into two smaller arteries (one being the continuation of the main branch and the other often referred to as the side branch). Bifurcations present a common location for the buildup of plaque and are particularly difficult to treat with currently available stents. Conventional coronary stents were designed to treat tubular arteries and are considered less than optimal for the y-shaped anatomy of a bifurcation. The TAXUS Petal Stent is designed specifically to treat both the main branch and the side branch of a bifurcation.
The TAXUS Petal Stent consists of a traditional drug-eluting stent with an innovative side structure (the Petal Strut) in the middle of the stent that opens into the side branch. The TAXUS Petal is designed to provide access, coverage and support to the critical areas of the bifurcation and uses a proprietary platinum chromium alloy. Platinum chromium is designed to offer an improvement over stainless steel and cobalt chromium, enabling even thinner struts, increased flexibility and improved radiopacity. The TAXUS Petal Stent is coated with the proven, market-leading combination of the Paclitaxel drug and Translute™ polymer.
"The TAXUS Petal Stent enabled us to successfully treat a patient with a difficult bifurcation (coronary branch point) stenosis. Bifurcations are a major challenge in interventional cardiology, and the development of a dedicated drug-eluting bifurcation stent is an important advancement," said Dr. Ormiston, the principal investigator for the TAXUS Petal I FHU Trial. "A major strength of the TAXUS Petal Stent design is to provide consistent mechanical support and drug application not only to the main branch and but also to the side-branch ostium, where renarrowing is common with other techniques used today."
The TAXUS PETAL I FHU clinical trial is a non-randomized study with an initial assessment of acute performance and safety (death, myocardial infarction, target vessel revascularization) at 30 days and six months, as well as continued annual follow-up for five years. TAXUS PETAL I FHU will enroll a total of 45 patients in New Zealand, France and Germany. Upon successful completion of this study, Boston Scientific intends to begin a pivotal trial to gain U.S. and international approval for the commercialization of the TAXUS Petal Stent.
"We are excited about the start of the TAXUS PETAL I FHU Trial," said Hank Kucheman, Senior Vice President and Group President, Interventional Cardiology. "Boston Scientific is committed to developing innovative technologies that enable physicians to treat their most difficult patients. The TAXUS Petal Stent program reinforces our unparalleled pipeline of developing stent technologies."
The TAXUS Petal Stent is under development and not available for sale.
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 product development and commercialization, clinical trials, intellectual property, regulatory approvals, competitive offerings, Boston Scientific's overall business strategy, and other factors described in Boston Scientific's filings with the Securities and Exchange Commission.
CONTACT: Paul Donovan 508-650-8541 (office) 508-667-5165 (mobile) Media Relations Boston Scientific Corporation Dan Brennan 508-650-8538 (office) 617-459-2703 (mobile) Investor Relations Boston Scientific Corporation
SOURCE: Boston Scientific Corporation
CONTACT: Paul Donovan, Media Relations, +1-508-650-8541 (office),
+1-508-667-5165 (mobile), or Dan Brennan, Investor Relations, +1-508-650-8538
(office), +1-617-459-2703 (mobile), both of Boston Scientific Corporation
Web site: http://www.bostonscientific.com/