14 May 2020 – MedAlliance has announced the award of its second CE Mark: SELUTION SLR™ 014 PTCA, a novel Sirolimus Drug Eluting Balloon (DEB), for the treatment of coronary arterial disease. This includes indications for both de-novo lesions as well as in-stent restenosis. The approval applies to a broad range of balloon sizes, from 1.5 x 10mm up to 5.0 x 40mm.
14 April 2020 – MedAlliance has announced enrollment of the first patient in the SAVE* study utilizing their novel sirolimus-eluting balloon, for the treatment of failed arteriovenous (AV) fistulae in renal dialysis patients. AV fistulae, artificial connections between an artery and vein, are created to improve the efficiency and sustainability of renal dialysis. AV Fistula is the third Breakthrough Device designation MedAlliance has been awarded by the FDA for its novel technology.
MedAlliance Receives CE Mark Approval for SELUTION SLR™ Sirolimus Drug Eluting Balloon for Endovascular Applications
3 February 2020 – MedAlliance has announced the award of its first CE Mark approval: for SELUTION SLR™, a novel Sirolimus Drug Eluting Balloon (DEB), for the treatment of peripheral arterial disease. This approval applies to sizes from 2.0 x 20mm to 7.0 x 150mm.
MedAlliance Receives Third FDA Breakthrough Device Designation Status for its Sirolimus Drug-Eluting Balloon in the Treatment of AVF Indications
14 January 2020 – 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 AV-Fistula indications. This is the third breakthrough designation awarded to MedAlliance for its sirolimus DEB, following coronary in-stent restenosis and peripheral below-the-knee indications.
10 January 2020 – MedAlliance has announced completion of patient enrolment in the PRESTIGE* Below-the-Knee (BTK) clinical trial. The objective of this clinical investigation is to evaluate the six-month 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).
6 January 2020 – Sirolimus-eluting balloon specialist MedAlliance has announced the appointment of Scott Addonizio as Chief Operating Officer. Scott has an excellent track record and reputation in the global medical device industry, with over 24 years’ experience. This includes expertise in balloon manufacturing, in-depth knowledge of the global coronary, peripheral and AV Fistula marketplace, as well as a solid understanding of the global regulatory environment.
Las Vegas, 5 November 2019 – Two-year data from the First-in-Human study of SELUTION SLR™, MedAlliance’s novel sirolimus-eluting balloon, was presented today at VIVA 2019 by Principal Investigator Professor Thomas Zeller, Universitaets-Herzzentrum, Bad Krozingen, Germany. The study involved 50 patients treated with the investigational device in lesions of the superficial femoral artery (SFA) and popliteal artery.
MedAlliance Receives FDA Breakthrough Device Designation Status for Sirolimus Drug-Eluting Balloon to Treat Below-the-Knee Disease
MedAlliance, the first drug-eluting balloon company in the world to receive US Food and Drug Administration (FDA) Breakthrough Device Designation Status for the treatment of coronary ISR, has been awarded similar status for SELUTION SLR™, its sustained limus release drug-eluting balloon (DEB) catheter, for the treatment of Below-the-Knee Disease.
Swiss-based M.A. MedAlliance SA has been granted Breakthrough Device Designation from the US Food and Drug Administration (FDA) for SELUTION™, its sustained limus release (SLR) drug-eluting balloon (DEB) catheter, for the treatment of coronary disease.
M.A. MedAlliance SA, a company developing and commercializing the first sirolimus micro-reservoir drug-coated balloon (SELUTION™ DCB) to treat patients suffering from peripheral artery disease (PAD), coronary artery disease (CAD), arteriovenous fistulas (AVF) and grafts (AVG) for end-stage renal disease, has raised $37 million.