MedAlliance has announced enrollment of the first patient in its study of Selution SLR 014” drug eluting balloon (DEB) for the treatment of in-stent restenosis. According to the company, this is the first DEB to be accepted by the US Food and Drug Administration (FDA) for its Breakthrough Programme. 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).
The prospective, randomised, single-blind multicentre study aims to demonstrate the safety and efficacy of Selution SLR in treatment of in-stent restenosis with either drug-eluting or bare metal stents (BMS). The study will support submission for FDA approval. The press release details that up to 418 subjects will be recruited into the study at approximately 60 sites across the USA and Europe. Subjects need to have a BMS or DES in-stent restenosis involving a native coronary artery with a reference vessel diameter (RVD) of 2–4.5mm to qualify for inclusion. Subjects will be randomised to receive either Selution SLR or standard of care (SOC), a control group with a current DES or a non-drug eluting balloon angioplasty.
The primary endpoint for effectiveness of the study is target lesion failure (TLF), defined as all cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularisation (TLR) at 12 months. Subjects will be followed up at one month, six months, 12 months, and then annually through five years.
“This is a particularly important study for MedAlliance”, explains chairman and CEO Jeffrey B Jump in the statement. “No coronary drug-eluting balloon has yet been approved in the USA, where ISR currently represents 11% of all stent implantations. We are excited to introduce this breakthrough technology to help patients around the world.”
MedAlliance says that Selution SLR’s technology involves unique MicroReservoirs made from biodegradable polymer intermixed with the anti-restenotic drug sirolimus. These MicroReservoirs provide controlled and sustained limus release of the drug. It says extended release of sirolimus from stents has been demonstrated to be 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.
Selution SLR was awarded CE mark for the treatment of peripheral artery disease in February 2020, and for the treatment of coronary arterial disease in May 2020.