October 9, 2008 - Boston Scientific Corp. yesterday said it completed enrollment in the PERSEUS trial, designed to evaluate the company’s third-generation TAXUS Element paclitaxel-eluting coronary stent.
The PERSEUS clinical program has enrolled nearly 1,500 patients at 100 U.S. and international centers since July 2007, and will compare the TAXUS Element Stent to the prior-generation TAXUS Express2 Stent marketed in the U.S. since 2004. The company plans to develop additional versions of the Element platform, including next generations of a bare-metal stent and an everolimus-eluting PROMUS Element stent system.
The Element Stent platform features the proprietary platinum chromium alloy, designed specifically for stents. This alloy, coupled with an innovative new stent architecture, is designed to enable thinner struts for increased flexibility, a lower profile, and improved radial strength, recoil, and radiopacity. In addition, the TAXUS Element Stent System incorporates new balloon technology, intended to improve on Boston Scientific's market-leading Maverick Balloon Catheter platform.
“The new alloy and stent design of TAXUS Element provides improved deliverability and visibility, even in patients with complex and challenging anatomy,” said Dean J. Kereiakes, M.D., medical director at The Christ Hospital Heart and Vascular Center and The Lindner Research Center in Cincinnati and the principal investigator for the trials. “I am very enthusiastic about the potential the TAXUS Element Stent offers me to treat a broader range of patients.”
The TAXUS PERSEUS clinical program will evaluate the efficacy and safety of the TAXUS Element Stent in two studies.
The first study, TAXUS PERSEUS Workhorse (A Prospective Evaluation in a Randomized Trial of the Safety and Efficacy of the Use of the TAXUS Element Paclitaxel-Eluting Coronary Stent System for the Treatment of De Novo Coronary Artery Lesions), will evaluate the safety and efficacy of the TAXUS Element Stent compared to Boston Scientific’s first generation drug-eluting stent, the TAXUS Express Stent. This 3:1 randomized study will evaluate 1,264 patients from 94 sites in the U.S., Australia, New Zealand and Singapore with “workhorse” lesions from 2.75 to 4 mm in diameter. The primary endpoint of the workhorse study is target lesion failure (TLF) at 12 months, and its secondary endpoint is in-segment percent diameter stenosis at nine months.
A second parallel study named the TAXUS PERSEUS Small Vessel study will compare the TAXUS Element Stent to a historic control (TAXUS V de novo bare-metal Express Coronary Stent System). This study will include 224 patients from 35 U.S. sites with lesions from 2.25 up to 2.75 mm. The primary endpoint of the small vessel study is in-stent late loss at nine months, and its secondary endpoint is TLF at 12 months.
The TAXUS Element Stent is an investigational device and is limited by federal law to investigational use only and is not available for sale. Boston Scientific is currently seeking CE Mark approval in European markets, which is anticipated in 2009.
For more information: www.bostonscientific.com