June 18, 2009 – Abbott this week initiated SPIRIT PRIME, a clinical trial to study the performance of the company's next-generation Xience PRIME Everolimus-Eluting Coronary Stent System, currently an investigational device, for the treatment of coronary artery disease.
Results from SPIRIT PRIME will be used to support the regulatory filing for Xience PRIME in the U.S. The first patient was enrolled into the SPIRIT PRIME clinical trial at Hillcrest Medical Center in Tulsa, Okla., by Rajesh Chandwaney, M.D.
The company said the Xience PRIME utilizes the same well-studied drug and proven biocompatible polymer as Abbott's market-leading Xience V Everolimus-Eluting Coronary Stent. In addition, it offers a novel stent design and a modified delivery system designed for greater flexibility and improved deliverability, the company said. Xience PRIME uses cobalt chromium technology, which allows for very thin struts, while maintaining strength to support the vessel as well as excellent visibility under X-ray during the stent implantation procedure. The stent is based upon the proven design of the MULTI-LINK family of stents, one of the most widely used stent platforms in the world, with more than 2 million implants. The company expects to launch Xience PRIME in a broad size matrix with sizes up to 38 mm in Europe later this year.
"Xience PRIME carries the same successful drug and polymer as the Xience V stent. Its stent platform and delivery balloon are designed to be highly deliverable, and as such, Xience PRIME has the potential to simplify procedures in challenging cases," said Marco A. Costa, M.D., Ph.D., FACC, FSCAI, professor of medicine, director of the Interventional Cardiology Center, and director of the Center for Research and Innovation, Harrington-McLaughlin Heart and Vascular Institute, University Hospitals Case Medical Center, Case Western Reserve University in Cleveland, Ohio, and principal investigator of the SPIRIT PRIME trial. "Xience V is used routinely in my practice, and I look forward to studying the enhanced features and sizes of Abbott's next-generation drug eluting stent, Xience PRIME."
The SPIRIT PRIME study is a prospective, multicenter, nonrandomized trial designed to study Xience PRIME in 500 patients at 75 hospital centers. Patients may receive a maximum of two stents in separate vessels. SPIRIT PRIME will have two arms: the Core Size arm will follow 400 patients who will be treated with a stent from 2.25 mm to 4 mm in diameter and from 8 mm to 28 mm in length, and the Long Lesion arm will follow 100 patients who will receive a stent from 2.5 mm to 4 mm in diameter and either 33 mm or 38 mm in length. The primary endpoint is major adverse cardiac events (MACE), which is a composite measure of cardiac death, heart attack (myocardial infarction) and repeat procedure of the treated lesion (target lesion revascularization) at one year.
For more information: www.abbott.com, www.xiencev.com