News | September 16, 2008

Medtronic Starts Trials of Endeavor Resolute Drug-Eluting Coronary Stent

September 17, 2008 - Medtronic Inc. said this week it started two new trials of the Endeavor Resolute drug-eluting stent (DES), the company’s complement to the Endeavor drug-eluting stent, which was approved by the FDA in February.

Clinical research teams led by interventional cardiologists Dr. James Carr at East Texas Medical Center in the U.S. and Dr. Franz-Josef Neumann at the Heart Center of Bad Krozingen in Germany enrolled the first patients in RESOLUTE U.S. (R-US) and RESOLUTE International (R-Int), respectively. The Endeavor Resolute zotarolimus-eluting coronary stent system is an investigational product in the U.S., where it is limited to investigational use only under an IDE (investigational device exemption) granted by the FDA. The device received the Conformité Européène (CE) mark in September 2007 and is commercially available in more than 100 countries around the world.

Medtronic said its drug-eluting stents use highly biocompatible polymers. The Endeavor Resolute DES uses the proprietary BioLinx polymer, which was designed to meet the same biocompatibility requirements as the phosphorylcholine (PC) polymer used in Medtronic’s flagship Endeavor stent. Compared to the PC polymer, the BioLinx polymer is designed to extend the duration of drug exposure in the vessel – an elution profile of potential relevance to patients that physicians consider to be at high risk of needing a repeat procedure. Developed by Medtronic scientists, it is the first polymer created specifically for use on a drug-eluting stent. Extensive preclinical studies have established both polymers’ biocompatibility and drug-delivery capabilities.

Medtronic’s portfolio of coronary stents provides physicians with a variety of stent choices to address the spectrum of clinical needs, the company said. The portfolio includes the Endeavor and Endeavor Resolute drug-eluting stents and the Driver and MicroDriver bare-metal stents. All of Medtronic’s coronary stents share the same cobalt alloy platform, which features a unique modular architecture and custom laser fusion patterns that together provide excellent radial strength and conformability to the vessel wall. Both of the company’s drug-eluting stents use the potent antiproliferative, noncytotoxic drug zotarolimus.

“Different patients require different treatment strategies, which is why the Endeavor Resolute stent and the RESOLUTE clinical program are so important for the future of interventional cardiology,” explained Dr. Martin Leon, associate director of the Cardiac Catheterization Laboratory at Columbia University Medical Center in New York, and one of three coordinating investigators for R-US. “These newly initiated trials have the potential to contribute significantly to the growing body of evidence that characterizes the safety and efficacy of the Endeavor Resolute DES.”

Dr. Petr Widimský, professor of medicine and cardiology at the Faculty Hospital of Kralovske Vinohrady in Prague, and one of three principal investigators for R-Int, added, “In many countries outside the United States, the Endeavor Resolute DES already provides an important option for the minimally-invasive treatment of coronary artery disease. The significant scale and scope of these multicenter registries will add to our understanding of how to use this new stent in standard clinical practice for the benefit of our wide range of patients.”

For more information: www.medtronic.com

Related Content

Abbott Initiates XIENCE Short DAPT Clinical Trial
News | Antiplatelet and Anticoagulation Therapies| August 03, 2017
Abbott recently announced the first patient has been enrolled in a clinical study evaluating the short-term use of...
FDA Approves Six-Month Primary Endpoint for Tack Endovascular System in Below the Knee Disease
News | Stents Peripheral| July 14, 2017
Intact Vascular Inc. announced the U.S. Food and Drug Administration (FDA) approved an Investigational Device Exemption...
Onyx DES 2.0 mm stent meets primary endpoints in small vessels
News | June 12, 2017
June 12, 2017 – The Medtronic Resolute Onyx Drug-Eluting Stent (DES) met its primary endpoint of target lesion failur
First Pennsylvania Patient Treated in LEADERS FREE II Trial of BioFreedom Drug-Coated Stent
News | Stents Drug Eluting| May 12, 2017
PinnacleHealth CardioVascular Institute enrolled the first patient in Pennsylvania in a trial assessing the safety and...
Resolute Onyx DES, drug eluting stent, medtronic, gains FDA approval
Technology | Stents Drug Eluting| May 01, 2017
May 1, 2017 — The U.S.
Sponsored Content | Videos | Stents Drug Eluting| May 01, 2017
This video, provided by Medtronic, demonstrates the Resolute Onyx coronary stent.
Tryton Medical, Side Branch Stent, first U.S. commercial case, New York-Presbyterian Hospital, Columbia University Medical Center
News | Stents Bifurcation| March 31, 2017
Tryton Medical Inc. recently announced that the first U.S. commercial case using the Tryton Side Branch Stent was...
Sponsored Content | Videos | Stents Bioresorbable| March 30, 2017
Stephen Ellis, M.D., professor of medicine and director of interventional cardiology at Cleveland Clinic, discusses t
Gore Tigris Vascular Stent, Health Canada approval, PAD, peripheral artery disease
News | Stents Peripheral| March 16, 2017
W. L. Gore & Associates Inc. recently announced the Health Canada approval of the Gore Tigris Vascular Stent, a...
Overlay Init