MedAlliance has been awarded FDA Breakthrough Device Designation for the Selution SLR, which is a sustained limus release drug-eluting balloon catheter for the treatment of below-the-knee disease. According to a press release, the company was the first drug-eluting balloon company in the world to receive FDA Breakthrough Device Designation status for the treatment of coronary in-stent restenosis.
The press release reports that Selution’s technology involves unique micro-reservoirs made from biodegradable polymer intermixed with the antirestenotic drug sirolimus. It adds that these microreservoirs provide controlled and sustained release of sirolimus. MedAlliance’s proprietary CAT (cell adherent technology) enables the microreservoirs to be coated onto balloons and adhered to the vessel lumen when delivered via an angioplasty balloon.
Jeffrey B Jump, chairman and CEO of MedAlliance, comments: “MedAlliance is honoured to have our sirolimus drug-eluting balloon selected for the FDA’s Breakthrough Device programme a second time. This should give US patients faster access to a new technology with the potential to provide safer and more effective treatment.”
Clinical follow-up data on the company’s superficial femoral artery sirolimus drug-eluting balloon will be presented at the 2019 Transcatheter Cardiovascular Therapeutics (TCT) meeting (25–29 September, San Francisco, USA). TCT will also see the debut of the sirolimus drug-eluting balloon coronary first-in-man data from the Asian study in which 84% of the patients received the sirolimus balloon in coronary de novo lesions.