MedAlliance leads US Sirolimus DEB race: First US Patient enrolled into SELUTION SLR Coronary Sirolimus DEB Study
25th January 2023 – The first US patient has been enrolled at Medstar Washington Hospital Center in the SELUTION4ISR study evaluating SELUTION SLR™ to support FDA approval. This milestone follows Investigational Device Exemption (IDE) approval in the US in October 2022. SELUTION SLR is the first sustained limus release coronary drug-eluting balloon (DEB) to receive FDA IDE approval for In-Stent Restenosis (ISR) indications.
MedAlliance’s SELUTION SLR is the first DEB to receive coronary De Novo IDE approval, its fourth FDA IDE DEB Approval
January 10, 2023 – SELUTION SLR™ MedAlliance’s novel sirolimus-eluting balloon, has received conditional FDA Investigational Device Exemption (IDE) approval to initiate its pivotal clinical trial for the treatment of coronary de novo lesions.