Medtronic has begun two new trials for its Endeavor Resolute drug-eluting stent (DES), its complement to the Endeavor DES, which was approved by the FDA in February.
Clinical research teams are led by interventional cardiologists James Carr, MD, at East Texas Medical Center in Tyler for the U.S. arm, and Franz-Josef Neumann, MD, at the Heart Center in Bad Krozingen, Germany, for the international arm.
Carr and Neumann enrolled the first patients in RESOLUTE U.S. and RESOLUTE International, respectively, according to the Minneapolis-based Medtronic. 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 FDA IDE (investigational device exemption). The device received the CE mark in September 2007.
Medtronic said its DES use biocompatible polymers. The Endeavor Resolute DES uses the proprietary BioLinx polymer, 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, the company said. Developed by Medtronic, the company said it is the first polymer created specifically for use on a DES. Preclinical studies have established both polymers’ biocompatibility and drug-delivery capabilities.