The U.S. Food and Drug Administration (FDA) granted MedAlliance its fourth Breakthrough Device Designation for SELUTION SLR™, a sustained limus release drug-eluting balloon (DEB) catheter, to treat atherosclerotic lesions found in native coronary arteries. MedAlliance was the first company in the world to receive Breakthrough Device Designation for its sirolimus DEB. Jeffrey B. Jump, Chairman and CEO of MedAlliance, stated, “MedAlliance is honored to have our sirolimus DEB selected for the FDA’s Breakthrough Device Program for a fourth time. This may provide US patients faster access to our novel 90 day sustained sirolimus release technology, with the potential to provide safer and more effective treatment. This Designation, combined with the previous coronary ISR Breakthrough Designation, will give US cardiologists exciting new tools to fight coronary disease.”
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