MedAlliance has announced the award of its second CE mark: Selution SLR 014 percutaneous transluminal angioplasty balloon, which is a novel sirolimus-eluting balloon for the treatment of coronary arterial disease. This includes indications for both de novo lesions as well as in-stent restenosis. The approval applies to a broad range of balloon sizes, from 1.5 x 10mm up to 5.0 x 40mm.
According to a press release, this award was supported by one-year results from the SELUTION SLR First-in-Human study, involving 56 patients enrolled across six Asian centres, nearly half (46.6%) of whom had diabetes. 87.6% of patients had de novo lesions and 12.4% had in-stent restenosis (ISR) lesions.
The primary endpoint of the study, freedom from device and procedure-related mortality through 30 days, was achieved in 100% of patients. There was no major adverse cardiovascular events (MACE) reported up to 30 days, and only one case occurring up to one year. Selution SLR demonstrated similar efficacy and safety to a drug-eluting stent, with only a single patient requiring target lesion revascularisation. This single case accounted for the low overall MACE rate of 2% at 12 months. Investigators concluded that the data in this study support the safety, efficacy and optimal performance of Selution SLR in coronary applications.
Robert Byrne (Director of Cardiology, Mater Private Hospital, Dublin, Ireland) says: “We are excited to have this new tool in our fight against de novo coronary stenosis. We look forward to studying this innovative technology head to head against drug-eluting stent. Limus drug-eluting balloon may compliment traditional drug-eluting stent in addressing issues like stent thrombosis, as well as the treatment of small vessels, long diffuse lesions, side branches and bifurcations which remain a challenge for drug-eluting stents”.
MedAlliance chairman and CEO Jeffrey B Jump comments: “We are very excited to have been awarded our second CE mark, which is testament to the documented efficacy and safety of our novel sustained-release limus-eluting balloon in the treatment of coronary applications. Selution SLR is designed to deliver the same safety and performance as best-in-class drug-eluting stent technology with the added benefit of leaving nothing behind.”