May 14, 2020
MedAlliance Gains CE Mark Approval for Coronary Selution SLR Sirolimus-Eluting Balloon
May 14, 2020—MedAlliance SA announced European CE Mark approval for the Selution SLR 014, a sirolimus drug-eluting balloon (DEB) with sustained limus-release (SLR) for the percutaneous transluminal coronary angioplasty to treat of coronary artery disease. The approval includes indications for both de novo lesions and in-stent restenosis (ISR). The approval applies to a range of balloon sizes from 1.5 X 10 mm to 5 X 40 mm.
According to the company, the CE Mark was supported by 1-year results from the SELUTION SLR first-in-human study that was composed of 56 patients enrolled in six Asian centers, of which 46.6% had diabetes, 87.6% had de novo lesions, and 12.4% had ISR lesions. Investigators concluded that the data support the safety, efficacy, and optimal performance of the Selution SLR device in coronary applications.
The primary endpoint of the study, freedom from device- and procedure-related mortality through 30 days, was achieved in 100% of patients. There were no major adverse cardiovascular events (MACEs) reported up to 30 days, and only one case occurring up to 1 year. The Selution SLR demonstrated similar efficacy and safety to a drug-eluting stent (DES), with only a single patient requiring target lesion revascularization that accounted for the low overall MACE rate of 2% at 12 months.
“We are excited to have this new tool in our fight against de novo coronary stenosis,” commented Professor Robert Byrne in the company's announcement. Prof. Byrne is Director of Cardiology at the Mater Private Hospital in Dublin, Ireland, and the Chair of Cardiovascular Research at the Royal College of Surgeons. He continued, “We look forward to studying this innovative technology head to head against DES. Limus DEB may complement traditional DES in addressing issues like DES thrombosis, as well as the treatment of small vessels, long diffuse lesions, side branches, and bifurcations, which remain a challenge for DES.”
In February 2019, MedAlliance announced that it has been granted FDA Breakthrough Device designation for Selution for the treatment of coronary artery disease. The Selution SLR has now achieved this status for a range of indications: the treatment of coronary in-stent restenosis, arteriovenous fistula, and peripheral below-the-knee lesions.
The company received CE Mark approval for Selution SLR for the treatment of peripheral artery disease in February 2020.