MedAlliance has been awarded CE mark for the Selution SLR 014 percutaneous transluminal coronary angioplasty (PTCA), a novel sirolimus drug eluting balloon (DEB), for the treatment of coronary artery disease. This includes indications for both de-novo lesions and in-stent restenosis. The approval applies to a broad range of balloon sizes, from 1.5x10mm up to 5x40mm.
A press release from MedAlliance says the 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 were no MACE (major adverse cardiovascular events) 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 (DES), with only a single patient requiring target lesion revascularisation (TLR). This single TLR 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.
MedAlliance chair and CEO Jeffrey B Jump states in the press release: “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 the added benefit of leaving nothing behind.”
In February 2020, MedAlliance received CE mark approval for Selution SLR for treatment of peripheral artery disease. The company statement says that MedAlliance is the first DEB company in the world to receive US Food and Drug Administration (FDA) Breakthrough Device Designation Status for coronary DEB. Selution SLR has achieved for a range of indications—treatment of AV-fistula, coronary in-stent restenosis, and peripheral below-the-knee lesions. It adds that Selution SLR’s technology involves unique MicroReservoirs made from biodegradable polymer intermixed with the anti-restenotic drug sirolimus. These MicroReservoirs provide controlled and sustained release of the drug. 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 MicroReservoirs to be coated onto balloons and adhered to the vessel lumen when delivered via an angioplasty balloon.