MedAlliance’s SELUTION SLR drug-eluting balloon (DEB) receives FDA investigational device exemption (IDE) approval, making it the first limus DEB to be available to US patients
The SELUTION SLR (Sustained Limus Release) is a novel sirolimus-eluting balloon that provides a controlled sustained drug release, similar to a drug-eluting stent (DES). SELUTION SLR was also the first DEB (Drug Eluting Balloon) granted “breakthrough device designation” by the FDA on March 4, 2019 and further in September 25, 2019 for below-the-knee (BTK) indications […]