MedAlliance has announced completion of patient enrollment in the SAVE Clinical Trial with the SELUTION SLR™ 018 DEB (drug-eluting balloon) for the treatment of failed AVF (arteriovenous fistulas) in renal dialysis patients. SELUTION SLR is a novel sirolimus-eluting balloon that provides a controlled sustained release of drug, similar to a drug-eluting stent (DES).
SAVE (Use of the Selution Sirolimus Eluting Balloon for Dysfunctional AV accEss Treatment Indications) is a prospective multi-center, single-blinded, randomized controlled trial. 84 patients have been randomized to either standard high-pressure balloon angioplasty followed by local application of SELUTION SLR or high-pressure balloon angioplasty with no further lesion treatment. Subjects have been recruited at three sites in Europe and Singapore and are being followed up to 24 months. Endpoints of the study are primary patency at six months with angiographic follow up and freedom from serious adverse events at 30 days. Major secondary endpoints at six months are clinical success, freedom from serious adverse events, late lumen loss and binary vessel restenosis. (clinicaltrials.gov NCT04327609).
“We very much look forward to the analysis of the primary endpoint of this important trial at six months, as this is the first prospective randomized trial of a sirolimus-coated balloon in AVF patients with angiographic follow-up. Furthermore, we have also measured fistula volume flow rates, which is another key index of failing or maintained fistula function. I thank MedAlliance for initiating a trial in this difficult patient population” commented Principal Investigator (PI) Dr. Konstantinos Katsanos, MSc, MD, PhD, EBIR, Associate Professor of Interventional Radiology, Patras University Hospital , Patras, Greece.
“MedAlliance continues to invest in meaningful clinical trials to evaluate the safety and efficacy of SELUTION SLR in different patient populations”, added Jeffrey B. Jump, Chairman and CEO of MedAlliance. Patients on dialysis rely on access to receive their treatment: they call this their “lifeline”. An Arteriovenous Fistula (AVF) is considered as the gold standard for hemodialysis access, however it sometimes requires ongoing angioplasty. This is the first randomized study evaluating SELUTION SLR in stenotic lesions in AVF.
MedAlliance was the first drug-eluting balloon company to receive FDA Breakthrough Designation status. Currently three IDE clinical studies are evaluating SELUTION SLR in the US: in CLTI patients with BTK disease; SFA/PPA; and coronary ISR. In addition, MedAlliance received IDE approval for de novo coronary artery lesions in January 2023. SELUTION SLR was awarded CE Mark Approval for the treatment of coronary artery disease in May 2020. This complements the substantial experience that the company has gained with the SELUTION DeNovo and SUCCESS trials in Europe & SELUTION SFA in Japan.
MedAlliance’s unique DEB technology involves MicroReservoirs which contain a combination of biodegradable polymer intermixed with the anti-restenotic drug sirolimus, applied as a coating on the surface of an angioplasty balloon. These MicroReservoirs provide controlled and sustained release of the drug for up to 90 days. MedAlliance’s proprietary CAT™ (Cell Adherent Technology) enables the MicroReservoirs to be coated onto balloons and efficiently transferred to adhere to the vessel lumen when delivered via expansion of the balloon.
SELUTION SLR is commercially available in Europe, Asia, the Middle East, and the Americas (outside USA) and most other countries where the CE Mark is recognized. Over 50,000 units have been used for patient treatments in routine clinical practice or as part of coronary clinical trials.