Abbott (NYSE:ABT) said today it won approval from the Japanese Ministry of Health, Labor and Welfare for its Absorb bioresorbable heart stent, touting it as the 1st fully dissolving heart stent approved in the country.
The stent is now cleared for use in patients with coronary artery disease, the Chicago-based company said, with approval coming supported by the company’s Absorb Japan study of the device.
“Absorb has the potential to address the unsolved challenges of managing coronary artery disease with conventional drug eluting metallic stents. Our research, which involved 400 patients at 38 Japanese sites, shows that this fully dissolving stent delivered comparable results to the best-in-class Abbott Xience metallic drug-eluting stent on clinically important measures of safety and efficacy,” Absorb Japan study principal investigator Dr. Takeshi Kimura of Kyoto University Hospital said in a press release.
The Absorb everolimus-eluting stent, which is designed to dissolve completely after approximately 3 years, won pre-market approval from the FDA in July. Japan clocks in as the 2nd largest single-country market for medical devices, according to Abbott, just behind the U.S.
“We’re very excited to bring the promise of Absorb to patients in Japan. We believe the Absorb bioresorbable stent can help people live better, healthier lives without the concern of a having a metal implant,” Abbott vascular senior veep Deepak Nath said in prepared remarks.
The Absorb GT1 landed CE Mark approval in the European Union in May 2015. The Absorb stent met the primary endpoint in a Phase III pivotal trial, researchers announced last October at the annual Transcatheter Cardiovascular Therapeutics conference.
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