Switzerland-based medical technology firm MedAlliance has secured the CE Mark approval for its SELUTION SLR 014 PTCA, a novel Sirolimus Drug Eluting Balloon (DEB), to treat coronary arterial disease.
The European regulatory approval, which applies to a range of balloon sizes ranging from 1.5 x 10mm up to 5.0 x 40mm, indicated the device for both de-novo lesions and in-stent restenosis.
The company has designed SELUTION SLR’s technology using MicroReservoirs made from biodegradable polymer intermixed with anti-restenotic drug sirolimus. The device has been granted CE Mark approval in February 2020, for treatment of peripheral artery disease.
MedAlliance chairman and CEO Jeffrey B Jump said: “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 treatment of coronary applications.
“SELUTION SLR is designed to deliver the same safety and performance as best-in-class DES technology with added benefit of leaving nothing behind.”
SELUTION SLR First-in-Human trial reached the primary endpoint in all patients
The CE mark approval was granted based on one-year results from the SELUTION SLR First-in-Human trial, which enrolled 56 patients across six Asian centres.
The study has reached the primary endpoint of freedom from device and procedure-related mortality through 30 days, in 100% of patients, with no major adverse cardiovascular events (MACE) reported.
The efficacy and safety of SELUTION SLR in the study was similar to a drug-eluting stent (DES), with only a single patient requiring a target lesion revascularisation (TLR).
The investigators of the study concluded that the data is adequate to support the safety, efficacy and optimal performance of SELUTION SLR in coronary applications, said the company.
Royal College of Surgeons cardiovascular research Chair Robert Byrne said: “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 DES.
“Limus DEB may compliment 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.”
