MedAlliance announces successful completion of enrolment in ISABELLA clinical trial for the treatment of failing AV fistulas in hemodialysis patients

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).

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First Two Patients Enrolled in PRISTINE Study with SELUTION SLR™ Sirolimus Drug Eluting Balloon

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).

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World’s First FDA IDE Coronary Patient Treated With a DEB

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).

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First Patient Enrolled Globally in SELUTION SLR™ Study for AV Fistula

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.

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