Three-year clinical results of Medtronic's Resolute Zotarolimus-Eluting Coronary Stent released

Sep 22 2009

New clinical data released today at a major meeting of interventional cardiologists show strong and sustained efficacy and safety of the Resolute^® Zotarolimus-Eluting Coronary Stent from Medtronic, Inc. (NYSE: MDT) in long-term patient follow-up.

The single-arm RESOLUTE trial>

The three-year results of RESOLUTE were released at Transcatheter Cardiovascular Therapuetics (TCT) 2009, which runs Sept. 21 – 25 at San Francisco’s Moscone Center.

“RESOLUTE included patients with a high degree of complexity for an initial clinical trial of a new drug-eluting stent,” said principal investigator Prof. Ian Meredith of Monash Medical Center in Australia. “Their remarkable outcomes at three years suggest that the Resolute DES offers a durable combination of long-term safety and efficacy that bodes well for the broad range of patients we see in the challenging environment of standard clinical practice.”

Average lesion length of RESOLUTE patients 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 70 percent had a history of smoking.

The Resolute DES features Medtronic’s proprietary BioLinx™ polymer system, which was designed to minimize inflammation, to reduce thrombotic risk and to enable rapid, complete and functional healing of the treated vessel. The BioLinx system has demonstrated the same biocompatibility requirements as the phosphorylcholine (PC) polymer used in the company’s Endeavor^® Zotarolimus-Eluting Coronary Stent. Compared to the PC polymer, the BioLinx system is designed to extend the duration of drug exposure in the vessel – an elution profile of potential relevance to patients whom 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 Resolute DES is commercially available in more than 100 countries outside the United States, where it is limited to investigational use in an FDA-approved clinical trial called RESOLUTE US. Medtronic is collaborating with physicians around the world to complete a global clinical trial program that will enroll more than 7,500 patients worldwide, with more than 6,300 patients receiving a Resolute DES.

www.medtronic.com