Abbott seeks Xience regulatory approval in Japan
Abbott has submitted an application for a Seizo Hanbai Shonin (marketing authorization license) to Japan's Ministry of Health, Labor and Welfare/Pharmaceuticals and Medical Devices Agency to gain approval for its Xience V everolimus-eluting coronary stent system to treat coronary artery disease.
The Shonin application for Xience V consisted of safety and efficacy data from the SPIRIT III clinical trial, including data from a Japanese patient population, according to the Abbott Park, Ill.-based company.
“Results of the SPIRIT III Japan Registry were very similar with those of the U.S. randomized clinical trial, which was the first head-to-head clinical trial to demonstrate the superiority of one drug-eluting stent over another drug-eluting stent," said Daniel Estay, divisional vice president of Abbott Vascular Asia Pacific and Japan. “Xience V represents an advancement in drug-eluting stent science and reinforces Abbott's deep commitment to providing physicians and patients in Japan with leading technologies and products in cardiac and vascular care.”
The Shonin application for Xience V consisted of safety and efficacy data from the SPIRIT III clinical trial, including data from a Japanese patient population, according to the Abbott Park, Ill.-based company.
“Results of the SPIRIT III Japan Registry were very similar with those of the U.S. randomized clinical trial, which was the first head-to-head clinical trial to demonstrate the superiority of one drug-eluting stent over another drug-eluting stent," said Daniel Estay, divisional vice president of Abbott Vascular Asia Pacific and Japan. “Xience V represents an advancement in drug-eluting stent science and reinforces Abbott's deep commitment to providing physicians and patients in Japan with leading technologies and products in cardiac and vascular care.”