18-Month Below-the-Knee Data with MedAlliance’s SELUTION SLR™ Presented as Late Breaking Trial at VIVA
8 October 2021 – 18-month results from the PRESTIGE* Below-the-Knee (BTK) study have been presented as a Late Breaking Clinical Trial at VIVA21. The objective of this clinical investigation has been to evaluate safety and performance outcomes of SELUTION SLR™, MedAlliance’s novel sirolimus-eluting balloon, for the treatment of long tibial occlusive lesions (TASC C & D) in patients with Critical Limb Ischemia (CLI).
21 September 2021 – MedAlliance, with its Japanese partner MDK Medical, has completed enrollment in the clinical study of its novel Sirolimus Drug Eluting Balloon (DEB), SELUTION SLR™, for the treatment of peripheral arterial disease (PAD). This follows the acceptance of a Clinical Trial Notification (CTN) by Japan’s Pharmaceutical and Medical Device Agency (PMDA) in June 2020.
MedAlliance Announces First Patient Enrolled in the 3,300 Patient Landmark Sirolimus DEB vs DES Study
Geneva – 31 August 2021 – MedAlliance is pleased to announce the enrollment of the first patient in the ground-breaking coronary randomized controlled study “SELUTION DeNovo”. This study utilizes SELUTION SLR™, a novel sirolimus drug-eluting balloon [DEB], versus a limus drug-eluting stent [DES].
MedAlliance Announces Enrollment of First Patient in Erectile Dysfunction Feasibility Study with Sirolimus Drug-Eluting Balloon
17 August 2021 – MedAlliance has announced enrollment of the first patient in an erectile dysfunction (ED) feasibility study with its sirolimus drug-eluting balloon [DEB]. This occurred at the University of Rome Tor Vergata, Italy, under the direction of the study’s Principal Investigator, Professor of Cardiovascular Interventional Pathology Giuseppe Sangiorgi.
12 August 2021 – MedAlliance has announced completion of patient enrolment in the PRISTINE clinical trial with SELUTION SLR™ 018 DEB (drug-eluting balloon) for the treatment of patients with Below-the-Knee (BTK) disease. SELUTION SLR is the first DEB to be awarded “Breakthrough Device Designation” by the FDA.