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Coronary DEB receives breakthrough designation from FDA
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MedAlliance SA announced its drug-eluting balloon for treatment of CAD has been given a breakthrough device designation by the FDA.
According to a press release from the company, the designation is granted to products that could improve treatment or diagnosis of life-threatening or debilitating diseases, and enables the agency to give priority review and communicate with the sponsor on device development and clinical trial protocols, with the goal of giving patients and providers timely access to the technology.
The DEB (Selution) has micro-reservoirs made from biodegradable polymers, which elute sirolimus in a controlled and sustained manner, and a cellular adhesive technology enables the micro-reservoirs to adhere to a balloon and the vessel lumen when delivered by an angioplasty balloon, the company stated in the release.
“MedAlliance is honored to have been selected for the FDA’s Breakthrough Devices Program, which will allow U.S. patients timely access to new technologies with the potential to provide safer and more effective treatment,” Jeffrey B. Jump, chairman and CEO of MedAlliance, said in the release.
Disclosure: Jump is an employee of MedAlliance SA.
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