News 2020

25 November 2020 – MedAlliance has announced completion of patient enrolment in the ISABELLA Clinical Trial with SELUTION SLR™ 018 DEB (drug-eluting balloon) for the treatment of dysfunctional AV fistulas in end-stage renal failure patients undergoing hemodialysis. SELUTION SLR (Sustained Limus Release) is a novel sirolimus-eluting balloon that provides a controlled sustained release of drug, similar to a drug-eluting stent (DES).

12 October 2020 – MedAlliance has announced enrolment of the first two patients in the PRISTINE registry with SELUTION SLR™ 018 DEB for the treatment of patients with Below The Knee disease (Chronic Limb Threatening Ischemia). This is the first DEB (drug-eluting balloon) accepted by the FDA for its “Breakthrough Program”. SELUTION SLR (Sustained Limus Release) is a novel sirolimus-eluting balloon that provides a controlled sustained release of drug, similar to a drug-eluting stent (DES).

7 July 2020 – MedAlliance has announced enrollment of the first patient in its study of SELUTION SLR™ 014 DEB for the treatment of In-Stent Restenosis (ISR). This is the first DEB accepted by the FDA for its “Breakthrough Program”. The SELUTION SLR (Sustained Limus Release) is a novel sirolimus eluting balloon that provides a controlled sustained release of drug, similar to a drug-eluting stent (DES).

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.

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.

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.