MedAlliance, with its Japanese partner MDK Medical, has completed enrolment in the clinical study of its novel sirolimus drug-eluting balloon (DEB), Selution SLR, for the treatment of peripheral arterial disease (PAD). This follows the acceptance of a Clinical Trial Notification (CTN) by Japan’s Pharmaceutical and Medical Device Agency (PMDA) in June 2020.
The study involves 133 patients across 13 centres in Japan. Its objective is to assess the safety and efficacy of Selution SLR for the treatment of lesions of superficial femoral arteries and/or popliteal arteries. The study is a prospective, controlled, multicentre, open, single-arm clinical investigation. Its primary endpoint is the primary patency rate at 12 months. Secondary endpoints include major adverse events/target lesion revascularisation (TLR), primary patency, and the change of Rutherford classification/ankle-brachial index (ABI)/walking impairment questionnaire (WIQ).
“We are extremely pleased with the regulatory and quality expertise demonstrated by our partner MDK, and particularly proud that Japanese patients can now benefit from our unique technology. This is the first sirolimus DEB implanted in Japan, where the current paclitaxel coated balloon market generates more than US$100 million in revenue per year”, commented MedAlliance chairman and CEO Jeffrey B Jump.
Selution SLR was awarded CE mark approval for the treatment of PAD in February 2020 and for the treatment of coronary arterial disease in May 2020. The US Food and Drug Administration (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 arteriovenous fistula indications.
In August 2021, the first of over 3,000 patients was enrolled in a coronary randomised controlled study comparing Selution SLR with a limus drug-eluting stent (DES). According to a press release, this is the largest DEB study ever initiated and has the potential to change medical practice.