Medtronic Launches Resolute Integrity Coronary Stent System in Japan

August 28, 2012—Medtronic, Inc. (Minneapolis, MN) announced the launch of the Resolute Integrity coronary stent system in Japan for the treatment of coronary artery disease. Earlier this year, the device received Japanese regulatory and reimbursement approvals, which were supported by the results of the RESOLUTE Japan study. 

According to Medtronic, RESOLUTE Japan is a prospective, single-arm, open-label study that enrolled 100 patients at 14 Japanese medical centers between March and October 2009. The study's 2-year results, which were presented in July at the annual meeting of the Japanese Association of Cardiovascular Intervention and Therapeutics, showed the durability of the treatment effect with the Resolute drug-eluting stent. The RESOLUTE Japan study met its primary endpoint with an average in-stent late lumen loss at 8 months after implantation of 0.13 mm versus 0.42 mm in the study's historical control device (Taxus, Boston Scientific, Natick, MA). In the press release, RESOLUTE Japan principal investigator Shigeru Saito, MD, noted that the safety and effectiveness of the Resolute stent were further demonstrated with no cardiac deaths, stent thrombosis, or target lesion revascularization events out to 2 years.