The stent is designed to treat patients with peripheral artery disease in the superficial femoral artery or proximal popliteal artery, the Tokyo-based company said.
“The Misago stent has a flexible design and good radial force that we found performed well in the superficial femoral artery. Peripheral artery disease can have devastating consequences but we believe the Misago stent offers a durable treatment option for superficial femoral artery disease,” principal investigator Dr. John Fritz Angle said in a press release.
Terumo said it won FDA premarket approval for the device in May, based on 1-year data from a single-arm, multi-center non-randomized prospective clincial trial. The stent had been studied in more than 5000 patients, the company added.
“The lack of differences in outcomes among the patients studied supports the validity of multi-national trials which will streamline approvals in different nations and maximize resources while reducing costs. I can foresee future trials which build upon our harmonization study design,” chief primary investigator Dr. Takao Ohki said in a press release.
Terumo said that the trial reported a 0.9% rate of stent fracture after 12 months, as well as a 100% success rate in delivery to the lesion site.
“We look forward to partnering with the U.S. interventional medical community to bring the benefits of this novel technology, as well as others in the future, to patients in the U.S. We express our gratitude to all the OSPREY investigators that helped to advance the scientific knowledge of the Misago stent,” Terumo veep of marketing Chris Pearson said.