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.
21 July 2021 – MedAlliance has launched ORIGIN SC and ORIGIN NC, two high performance balloons for vessel preparation. These very much complement SELUTION SLR™, its novel sirolimus-eluting balloon.
MedAlliance Raises over USD 50 Million to Roll-Out SELUTION SLR™ and Begin Enrolment of Four US FDA Clinical Studies
17 March 2021 – MedAlliance SA, the company commercializing SELUTION SLR™, has raised over USD 50 Million in equity funding. SELUTION SLR™ is a novel sirolimus-eluting balloon that provides a controlled sustained release of a limus drug, with a similar elution time to that of a drug-eluting stent (DES), whilst leaving nothing behind. The new investor is Trustar Capital (formerly known as CITIC Capital Partners).
MedAlliance Receives Fourth FDA Breakthrough Device Designation for Sirolimus Drug-Eluting Balloon in Treatment of De Novo Coronary Lesions
3 March 2021 – MedAlliance, the first drug-eluting balloon (DEB) company in the world to receive US Food and Drug Administration (FDA) Breakthrough Device Designation Status for a sirolimus DEB, has now been awarded breakthrough status for SELUTION SLR™, its sustained limus release DEB catheter, in the treatment of atherosclerotic lesions in native coronary arteries. This is the fourth breakthrough designation awarded to MedAlliance for its sirolimus DEB, following coronary in-stent restenosis, peripheral below-the-knee and AV-Fistula indications
8 February 2021 – MedAlliance has announced enrolment of the first patient in SUCCESS PTA, its large post-market study with the drug-eluting balloon SELUTION SLR™ for the treatment of patients with peripheral artery disease (PAD). SELUTION SLR is a novel sirolimus-eluting balloon that provides a controlled sustained release of drug, similar to that of a drug-eluting stent (DES).
12-Month Below-the-Knee Data with MedAlliance’s SELUTION SLR™ Presented as Late Breaking Trial at LINC
28 January 2021 – 12-month results from the PRESTIGE* Below-the-Knee (BTK) study have been presented as a Late Breaking Trial at LINC 2021. 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).