News
First Patient Enrolled in SELUTION SLR IDE BTK Study
7 June 2022 – The first patient has been enrolled in the FDA IDE BTK (Below-the-Knee) SELUTION4BTK clinical trial involving SELUTION SLR™, MedAlliance’s novel sirolimus-eluting balloon, just one week after receiving IDE approval.
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
26 May 2022 – 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 granted “Breakthrough Device Designation” by the FDA on March 4, 2019 and further on September 25, 2019 for below-the-knee (BTK) indications in peripheral artery disease.