MedAlliance has announced enrollment of the first patient in the SAVE* study utilizing their novel sirolimus-eluting balloon. The device is intended 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.
SELUTION SLR’s technology involves unique Microreservoirs made from biodegradable polymer intermixed with the anti-restenotic drug sirolimus. These microreservoirs provide controlled and sustained release of the drug. Extended release of sirolimus from stents has been demonstrated highly efficacious in both coronary and peripheral vasculatures. MedAlliance’s proprietary CAT™ (Cell Adherent Technology) enables the microreservoirs to be coated onto balloons and adhered to the vessel lumen when delivered via an angioplasty balloon.
The objectives of this prospective, randomized, single-blind multi-center study are to demonstrate the safety and efficacy of SELUTION SLR in the treatment of failed AV fistulae in patients undergoing renal dialysis. This study will also qualify for EU MDR approval.
84 subjects are being randomized to either SELUTION SLR or POBA (Plain Old Balloon Angioplasty). To qualify for inclusion they must be aged 18-90, have a dialysis access that has performed at least one successful dialysis session, and a stenosis of more than 50% at the outflow vein.
The primary efficacy endpoint of the study will be primary patency of the treated lesion and of the treated circuit at six months post-intervention. The primary safety endpoint will be freedom from any serious adverse events involving the AV access circuit or the patient at 30 days.
AV Fistula is the third Breakthrough Device designation MedAlliance has been awarded by the FDA for its novel technology.
“We are excited to study this novel sustained release of sirolimus in our dialysis patients with a malfunctioning fistula”, said Dr. Konstantinos Katsanos, Consultant in Interventional Radiology, Patras University, Greece. “We truly look forward to the outcomes”.
“MedAlliance is honored to initiate this important study with Dr. Katsanos”, added Chairman and CEO Jeffrey B. Jump. “It will hopefully demonstrate extended life for AV Fistula patients around the world”.
* Use of the Selution sirolimus eluting balloon for dysfunctional AV accEss treatment indications