News

14 September 2023 – MedAlliance has announced enrollment of over 1,660 patients in its ground-breaking SELUTION DeNovo coronary randomized study. Recruitment is now half way towards a planned 3,326 patients. SELUTION DeNovo compares the treatment strategy using a novel sirolimus drug-eluting balloon [SELUTION SLR], versus any limus drug-eluting stent [DES].

6 September 2023 – The first patient has been enrolled in a UK study of large vessel de novo coronary artery disease treated with SELUTION SLR™. This is a trial initiated by physicians at the Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust, which is where the first patient was enrolled. SELUTION SLR is a novel sirolimus-eluting balloon that provides a controlled sustained release of drug, similar to a drug-eluting stent (DES).

14 August 2023 – MedAlliance has announced completion of patient enrollment in the  SAVE Clinical Trial with the SELUTION SLR™ 018 DEB (drug-eluting balloon) for the treatment of failed AVF (arteriovenous fistulas) in renal dialysis patients. SELUTION SLR is a novel sirolimus-eluting balloon that provides a controlled sustained release of drug, similar to a drug-eluting stent (DES).

30 May 2023 – 12-month results from the SELUTION SFA trial have been presented for the first time at the Japan  Endovascular  Treatment (JET) Conference in Tokyo. The objective of this study was to assess the safety and efficacy of  SELUTION SLR™, MedAlliance’s novel sirolimus-eluting balloon, for endovascular therapy of de novo and non-stented restenotic lesions in the superficial femoral artery (SFA) and popliteal artery (PA).  

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.

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].

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.

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.