|The Misago stent is undergoing trials for approval in the U.S. and Japan--courtesy of Terumo Medical|
Terumo Medical completed enrollment in a safety and effectiveness study of its Misago self-expanding stent, taking advantage of a pilot program that unites the FDA and Japan's regulatory body.
Under the FDA's Harmonization by Doing program, Terumo enrolled 200 patients in the U.S. and 100 in Japan to test the device's ability to treat atherosclerotic stenoses and occlusions of the superficial femoral artery. The pilot program is designed to shorten the time between approvals in the two nations.
Misago, already available in Europe, is a nitinol stent pre-mounted onto a rapid-exchange delivery catheter system. The device has three radiopaque markers located on each of its ends, allowing for accurate placement in lesions. The study's primary endpoints are patency after one year and freedom from major adverse events, Terumo said.
This is Misago's first U.S. trial for premarket approval, and Terumo brass is pleased with its progress, the company said. The Harmonization by Doing program, launched in 2010, will help accelerate Misago's journey to the market, said James Rushworth, president of Terumo Interventional Systems and Onset Medical Corporation, in a statement.
"Terumo is greatly appreciative of the tremendous support given by our U.S. clinical investigators, which helped us meet the critical enrollment goal in this landmark [Harmonization by Doing] initiative," Rushworth said.
- read Terumo's release
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