GENEVA, Aug. 16, 2023 /PRNewswire/ -- MedAlliance has announced completion of patient enrollment in the SAVE clinical trial with SELUTION SLR™ 018 DEB (drug-eluting balloon) for the treatment of failed AVF (arteriovenous fistulas) in kidney dialysis patients. SELUTION SLR is a novel sirolimus-eluting balloon that provides controlled sustained drug release, similar to a drug-eluting stent (DES).
SAVE (Use of Sirolimus-Releasing Balloon Selution for Treatment Indications of Dysfunctional AV Access) is a single-blind, multicenter, prospective randomized controlled trial. Eighty-four patients were randomized to standard high-pressure balloon angioplasty followed by local application of SELUTION SLR or high-pressure balloon angioplasty without additional lesion treatment. The subjects have been recruited at three sites in Europe and Singapore and are being followed for up to 24 months. Study endpoints are primary patency at 6 months with angiographic follow-up and absence of serious adverse events at 30 days. Primary secondary endpoints at six months are clinical success, absence of serious adverse events, late lumen loss, and restenosis of binary vessels. (clinicaltrials.gov NCT04327609).
"We look forward to the primary endpoint analysis 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. In addition, we have also measured fistula volume flow rates, which is another key index of failed or sustained fistula function. I am grateful to MedAlliance for initiating a trial in this difficult patient population," commented Principal Investigator (PI) Konstantinos Katsanos, MD, MSc , MD, PhD, EBIR, Associate Professor of Interventional Radiology, University Hospital of Patras, Patras, Greece.
"MedAlliance continues to invest in significant clinical trials to evaluate the safety and efficacy of SELUTION SLR in different patient populations," added Jeffrey B. Jump, President and CEO of MedAlliance. Dialysis patients depend on access to receive their treatment: they call it their "lifeline." An arteriovenous fistula (AVF) is considered the gold standard for hemodialysis access, however, it sometimes requires continuous angioplasty. This is the first randomized study evaluating SELUTION SLR in stenotic AVF lesions.
MedAlliance was the first drug-eluting balloon company to receive breakthrough designation status from the FDA. Three IDE clinical studies are currently evaluating SELUTION SLR in the US: in CLTI patients with BTK disease; SFA/PPA; and coronary RSI. In addition, MedAlliance received IDE approval for de novo coronary artery lesions in January 2023. SELUTION SLR received CE mark approval for the treatment of coronary artery disease in May 2020. This complements the substantial experience that the company has won with SELUTION DeNovo and SUCCESS Trials in Europe and SELUTION SFA in Japan.
MedAlliance's unique DEB technology involves MicroReservoirs containing a blend of biodegradable polymers interspersed with the anti-restenotic drug sirolimus, applied as a coating on the surface of an angioplasty balloon. These microreservoirs provide a controlled and sustained release of the drug for up to 90 days. MedAlliance's patented CAT™ (Cell Adherent Technology) allows microdeposits to be coated onto balloons and transferred efficiently to adhere to the lumen of the vessel when delivered via balloon expansion.
SELUTION SLR is commercially available in Europe, Asia, the Middle East and the Americas (outside the US) and most other countries where the CE mark is recognized. More than 50,000 units have been used for treatment of patients in routine clinical practice or as part of coronary clinical trials.
Richard Kenyonrkenyon@medalliance.com 44 7831 569940
MedAlliance is a medical technology company that announced a phased acquisition by Cordis in October 2022. It is headquartered in Nyon, Switzerland. MedAlliance specializes in the development of innovative technology and the commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery disease. For more information visit: www.medalliance.com
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