News
MedAlliance Enrolls First US Patient into its Third FDA IDE Study: SFA SELUTION4SFA
4 May 2023 – The first US patient has been enrolled in the SELUTION4SFA Sirolimus DEB study by Dr. Arthur Lee at the Cardiac & Vascular Institute in Florida. This study evaluates SELUTION SLR™ in the treatment of occlusive disease of the superficial femoral artery (SFA) and proximal popliteal artery (PPA) and has been designed to support FDA approval. It follows Investigational Device Exemption (IDE) approval in the US in August 2022. SELUTION SLR is the first and only limus release drug-eluting balloon (DEB) to receive FDA IDE approval for SFA and PPA indications.
Over 1,000 Patients Enrolled in Landmark SELUTION DeNovo Study
14 March 2023 – MedAlliance has announced enrollment of over 1,000 patients in its ground-breaking SELUTION DeNovo coronary randomized study. Recruitment is now a third of the way towards the target of 3,326 patients. SELUTION DeNovo compares the treatment strategy using a novel sirolimus drug-eluting balloon [DEB SELUTION], versus a limus drug-eluting stent [DES].
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.
MedAlliance SELUTION SLR Receives Coronary FDA IDE Approval
24th October 2022 – SELUTION SLR™, MedAlliance’s novel sirolimus-eluting balloon, has received FDA Investigational Device Exemption (IDE) approval to initiate its coronary pivotal clinical trial. This is the first sustained limus release coronary drug eluting balloon (DEB) to receive FDA IDE approval for In-stent Restenosis (ISR) indication. The study has already begun enrollment in Europe.