Fridley, Minn.-based Medtronic said the approval covers patients with severe aortic stenosis who are too sick to go through open heart surgery.
"Medtronic has been committed to bringing this life-saving therapy to patients in Japan. The feedback from heart teams around the world using CoreValve has been overwhelmingly positive and we are confident that Japanese physicians will embrace the therapy," heart valve therapies general manager Rhonda Robb said in prepared remarks. "We look forward to working with Japan’s Ministry of Health, Labor & Welfare to gain reimbursement for CoreValve, and to initiating comprehensive training and education programs to support heart teams so that more patients may benefit from this break-through technology."
The approval in Japan was based in part on Medtronic’s CoreValve Japan trial, which showed a 90.8% freedom from all-cause mortality at 6 months, the company said.
Transcatheter aortic valve implants once again took the spotlight at the annual meeting of the American College of Cardiology this month, with a spate of studies both confirming the long-term benefits of the replacement heart valves and showing that newer TAVI versions are even better.
"We are excited to be able to offer this new option for our patients, as the CoreValve system has demonstrated exceptional clinical results in studies globally as well as in Japan," Dr. Yoshiki Sawa of the Osaka University Graduate School of Medicine said in a press release. "Physicians in Japan should have confidence in making TAVI treatment decisions for patients who may benefit from a less invasive valve replacement procedure with this proven self-expandable valve."