Selution SLR, MedAlliance’s sirolimus-eluting balloon, has received conditional US Food and Drug Administration (FDA) investigational device exemption (IDE) approval to initiate its pivotal clinical trial for the treatment of occlusive disease of the superficial femoral artery (SFA).
This comes only a few months after the company received IDE approval for Selution SLR in the treatment of below-the-knee (BTK) indications (May 2022).
Enrolment will begin in the SELUTION SLR IDE SFA study later this year. It will be conducted at over 20 centres in the USA and an additional 20 centres around the world. This study will enrol 300 patients to demonstrate superiority over balloon angioplasty (POBA). The principal investigator of this study is George Adams, the director of cardiovascular and peripheral vascular research at Rex Hospital (Raleigh, USA).
“We are very excited that US patients suffering from PAD [peripheral arterial disease] will have the opportunity to receive this novel sirolimus drug coated balloon technology. This is yet another advancement in the field of treating vascular disease and we are confident that this study will enrol quickly,” Adams commented.
“This is a significant milestone for MedAlliance: we are the first non-paclitaxel drug coated balloon to receive IDE approval, and now the first to have two applications approved. This is the culmination of a multi-year research and development programme to provide the comprehensive non-clinical data required to satisfy the very high standards expected by the US FDA,” added Jeffrey B Jump, MedAlliance chairman and chief executive officer. “We are very pleased with the rapid level of sales growth we are experiencing in Europe, Asia and South America and very much look forward to entering the US market.”
Selution SLR was awarded CE mark approval for the treatment of PAD in February 2020 and for the treatment of coronary artery disease in May 2020. The US FDA has awarded Selution SLR with four breakthrough designations: for the treatment of atherosclerotic lesions in native coronary arteries; coronary in-stent restenosis; peripheral below-the-knee and AV-fistula indications.
In August 2021, the first of over 3,000 patients was enrolled in a ground-breaking coronary randomised controlled study comparing Selution SLR with any limus drug-eluting stent [DES]. This is the largest drug-eluting balloon (DEB) study ever initiated.
MedAlliance’s DEB technology involves MicroReservoirs made from biodegradable polymer intermixed with the anti-restenotic drug sirolimus. These MicroReservoirs provide controlled and sustained release of the drug for up to 90 days. Extended release of sirolimus from stents has been proven highly efficacious in both coronary and peripheral vasculatures. MedAlliance’s proprietary CAT (Cell Adherent Technology) enables the MicroReservoirs to be coated onto balloons and adhere to the vessel lumen when delivered via an angioplasty balloon.