Healthcare Industry News: XIENCE V
News Release - May 12, 2008
Medtronic Announces Start of International Study Comparing Endeavor(R) Resolute Drug-Eluting Stent to Abbott's Xience(R) VFirst Implants in Pivotal RESOLUTE III Trial Occur in Europe;
Now Available in More Than 100 Countries Outside the U.S., Second Next-Generation DES Has Expanded Treatment Options for Patients with Coronary Artery Disease
MINNEAPOLIS--(HSMN NewsFeed)--Continuing its commitment to clinical excellence, Medtronic, Inc. (NYSE: MDT ), today announced the start of an international study comparing the company’s Endeavor® Resolute Zotarolimus-Eluting Coronary Stent with Abbott Laboratory’s Xience® V Everolimus-Eluting Coronary Stent. The first implants in the study, called the RESOLUTE III All-Comers Trial, took place in Europe during the last two weeks.
The teams of Prof. Stephan Windecker of University Hospital Bern in Switzerland, one of three principal investigators (PIs), and Dr. William Wijns of the Cardiovascular Centre Aalst in Belgium, enrolled the first patients in RESOLUTE III on April 30. Prof. Sigmund Silber of the Heart Catheterization Centre in Munich, Germany, and Prof. Patrick Serruys of the Heartcenter, Rotterdam in the Netherlands are the trial’s other PIs.
RESOLUTE III is the pivotal trial for the Endeavor Resolute drug-eluting stent and one part of the comprehensive RESOLUTE clinical program. RESOLUTE III will randomize approximately 2,300 patients, in a one-to-one manner, to the Endeavor Resolute or Xience stent at 15–20 international medical centers in countries where both stents are commercially available. The primary endpoint for RESOLUTE III is target lesion failure (TLF), a composite of cardiac death, myocardial infarction (MI) and target lesion revascularization (TLR), at one year as defined by the Academic Research Consortium.
The initial clinical trial of the Endeavor Resolute drug-eluting stent, called RESOLUTE, met its primary endpoint, with in-stent late lumen loss at nine months of 0.22mm ±0.27mm, providing assurance of vessel healing in the targeted range while preventing repeat procedures. None of the patients in the single-arm study – they all received the Endeavor Resolute stent – required a repeat procedure through nine months; and none experienced a protocol-defined stent thrombosis through 12 months of follow-up. Among the trial’s 130 patients, only one required clinically driven TLR or TVR (target vessel revascularization), and the incidence of major adverse cardiac events was 8.5 percent, through 12 months.
The Endeavor Resolute stent received CE mark approval in October 2007 and is commercially available in more than 100 countries outside the United States. (Caution: The Endeavor Resolute drug-eluting stent is an investigational device in the United States, where it is limited to investigational use.) Endeavor Resolute expands Medtronic’s international portfolio of coronary stents, which also includes the Endeavor drug-eluting stent and the Driver bare-metal stent. Featuring innovative designs, the expanded portfolio provides physicians with a greater variety of stent choices to address the spectrum of clinical needs.
By minimizing neointimal tissue growth in the treated artery following an angioplasty procedure, drug-eluting stents reduce the need for repeat procedures compared to bare-metal stents, which are not coated with drugs. Both types of stents scaffold the artery to keep it propped open.
Endeavor Resolute draws upon the strengths of Endeavor, which was launched in Europe in August 2005 and is now available worldwide (except Japan), including (most recently) the United States and Canada. They share the same cobalt alloy stent platform, which provides excellent radial strength and conformability to the vessel wall. Both of Medtronic’s drug-eluting stents also use the potent antiproliferative drug zotarolimus. In addition, both use highly biocompatible polymers.
Endeavor Resolute uses a proprietary new biocompatible polymer called BioLinx™. The BioLinx polymer is designed to confer the same biocompatibility as the Endeavor stent’s phosphorylcholine (PC) polymer while extending the duration of drug exposure in the vessel. Developed by Medtronic scientists, BioLinx is the first polymer created specifically for use on a drug-eluting stent. The BioLinx polymer features a unique blend of hydrophilic and hydrophobic elements for optimal performance. Extensive preclinical studies have established the biocompatibility and drug delivery capabilities of the BioLinx polymer.
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s Annual Report on Form 10-K for the year ended April 27, 2007. Actual results may differ materially from anticipated results.
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