Medinol Ltd. today submitted a Pre- Market Approval (PMA) application for its next-generation NIRflex Premounted Stent system to the U.S. Food and Drug Administration (FDA). The PMA submission follows highly positive results from the NIRflex U.S. Study clinical trial. Submission of the PMA application is a critical milestone for Medinol toward FDA approval, which will allow Medinol to sell NIRflex stents in the U.S. market.
“The strong results of the clinical trial clearly show the safety and efficacy of the NIRflex Premounted Stent stent system in the treatment of stenotic lesions in native coronary arteries,” says Dr. Campbell Rogers of Brigham and Women’s Hospital and Harvard Medical School, principal investigator for the NIRflex U.S. Study. “The NIRflex stent will be an important addition to the stent field,” he adds. This multi-center, prospective, single arm, controlled clinical study enrolled 205 patients at 11 sites across the United States.
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