What’s more, there were no instances of stent thrombosis among the 130 study subjects – all of whom received an Endeavor Resolute DES – through 24 months of follow-up.
“The goal of the RESOLUTE clinical program is to extend the proven long-term safety and durable efficacy benefits that our flagship Endeavor DES offers to patients who are underserved by currently available treatment alternatives,” said Sean Salmon, vice president and general manager of the Coronary and Peripheral Vascular business at Medtronic. “The Resolute DES will complement our coronary stent portfolio as we seek to address the unmet clinical needs of patients at high risk of restenosis.”
The patients enrolled in RESOLUTE represented an unusually high degree of complexity for an initial clinical trial of a new DES. Average lesion length was 15.5 mm, and 82 percent of the subjects had challenging B2/C lesions. In addition, 46 percent had a prior myocardial infarction (MI), and 18 percent had a prior percutaneous coronary intervention (PCI); 18 percent had diabetes; 30 percent had unstable angina; and 22 percent were smokers at the time of enrollment.
“Based on the TLR and stent thrombosis rates of most other drug-eluting stents, the performance of Endeavor Resolute in this trial is encouraging,” said Prof. Ian Meredith of Monash Medical Centre in Australia and principal investigator of RESOLUTE. “That’s a credit to the noninflammatory properties of the drug zotarolimus and the BioLinx™ polymer’s biocompatibility and elution profile. The clinical and angiographic results are all the more impressive when you consider the complexity and challenging characteristics of the patients in the study.”
Medtronic’s portfolio of coronary stents provides physicians with choices to address the spectrum of clinical needs. The international portfolio includes the Endeavor and Endeavor Resolute drug-eluting stents and the Driver® and Micro-Driver bare-metal stents. All of Medtronic’s coronary stents share the same advanced cobalt alloy platform, which features a unique modular architecture that provides excellent radial strength but with high conformability to the vessel wall. Both of the company’s drug-eluting stents use the potent antiproliferative, noncytotoxic drug zotarolimus.
Medtronic’s two drug-eluting stents also 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 the Endeavor DES. 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 highest risk of needing a repeat procedure. Developed by Medtronic scientists, it is the first polymer created specifically for use on a DES.
The Endeavor Resolute Zotarolimus-Eluting Coronary Stent System is commercially available in more than 100 countries outside the United States, where it is limited to investigational use under an investigational device exemption granted by the U.S. Food and Drug Administration (FDA). It is being evaluated in the RESOLUTE clinical program, which will enroll more than 6,000 patients worldwide across a series of single-arm and randomized controlled trials and an international registry.
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.