MedAlliance announced today that the first patient was enrolled in a trial of its Selution SLR sirolimus-eluting balloon.
Last month, the company received FDA investigational device exemption (IDE) for the Selution SLR drug-eluting balloon, which it designed to provide a controlled sustained drug release, similar to a drug-eluting stent. The FDA IDE BTK (below-the-knee) Selution4BTK clinical trial comes on the heels of that IDE. Selution SLR was granted FDA breakthrough device designation in 2019.
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