Boston Scientific Corporation (NYSE: BSX) announced the completion of patient enrollment in the Small Vessel and Long Lesion trials of its PLATINUM clinical program. The trials are designed to compare the platinum chromium PROMUS® Element™ Everolimus-Eluting Stent System to matched historical control groups of patients treated with the TAXUS® Express2™ Paclitaxel-Eluting Stent System. The Small Vessel trial enrolled 94 patients with de novo lesions greater than or equal to 2.25 to less than 2.50 mm in diameter and less than or equal to 28 mm in length. The Long Lesion trial enrolled 102 patients with de novo lesions greater than 24 to less than or equal to 34 mm in length and greater than or equal to 2.50 to less than or equal to 4.25 mm in diameter. Both trials enrolled patients at more than 30 sites worldwide.
"Data from clinical studies have shown that small vessels and long lesions each represent an estimated 10 percent of percutaneous coronary interventions," said Gregg W. Stone, M.D., Professor of Medicine and the Director of Research and Education at the Center for Interventional Vascular Therapy at the Columbia University/New York-Presbyterian Hospital and Principal Investigator for the PLATINUM program. "The availability of everolimus-based small vessel and long lesion stents will allow physicians greater flexibility in treating a broad range of complex coronary lesions. We look forward to the results of these important trials."
PLATINUM is a pivotal, randomized, controlled clinical trial program designed to support U.S. Food and Drug Administration and Japanese Ministry of Health, Labor and Welfare approval of the PROMUS Element Stent. The Company received CE Mark approval for this product in October 2009. The PLATINUM Workhorse trial compares the PROMUS Element Stent to the PROMUS® Stent; it completed enrollment of 1,531 patients at 133 sites worldwide in September 2009. Results are expected to be presented in early 2011.
The PROMUS Element Stent is designed specifically for coronary stenting. The novel stent architecture and proprietary alloy combine to offer greater radial strength and flexibility. The stent architecture helps create consistent lesion coverage and drug distribution while improving deliverability, which is enhanced by an advanced catheter delivery system. The higher density alloy provides superior visibility and reduced recoil while permitting thinner struts compared to prior-generation stents(1).
"Boston Scientific has led the way in developing drug-eluting stents for small vessels and long lesions," said Hank Kucheman, Executive Vice President and Group President, Cardiology, Rhythm and Vascular for Boston Scientific. "The TAXUS® Express® Atom™ Stent and our more recent TAXUS® Liberte® Atom™ and TAXUS® Liberte® Long Stents have been adopted enthusiastically by our physician customers. The evaluation of a thin-strut, platinum chromium stent with a new drug offering reconfirms our commitment to providing the most complete range of solutions and sizes for physicians and their patients."
Boston Scientific stents have been evaluated by the industry's most extensive randomized, controlled clinical trial program, with follow-up on TAXUS Stents to five years in some cases. To date, approximately 11 million Boston Scientific stents have been implanted globally, making them the world's most frequently used stents.
In the U.S., the PROMUS Element Stent is an investigational device and is limited by applicable law to investigational use only and is not available for sale.
(1) Based on bench testing. Data on file with Boston Scientific.
Source
Boston Scientific Corporation
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