MedAlliance's Selution DCB Granted FDA Breakthrough Device Designation
February 28, 2019—MedAlliance SA, a Switzerland-based medical technology company, announced that it has been granted FDA Breakthrough Device designation for Selution, the company's sustained limus release (SLR) drug-coated balloon (DCB) catheter for the treatment of coronary artery disease.
According to MedAlliance, the FDA received the company's request to designate Selution as a Breakthrough Device in January 2019. The proposed indications for use include improving luminal diameter, after predilatation, in the treatment of coronary artery in-stent restenosis for stenotic lengths up to 36 mm with reference vessel diameters of 2.25 to 4.5 mm.
The company stated that under the Breakthrough Device Program, the FDA will provide MedAlliance with priority review and interactive communication regarding device development and clinical trial protocols, through to commercialization decisions. The goal of the program is to provide patients and health care providers with timely access to designated medical devices by speeding their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and de novo marketing authorization that are consistent with the FDA's mission to protect and promote public health.
MedAlliance noted that the Selution SLR DCB features microreservoirs made from biodegradable polymer intermixed with sirolimus. The microreservoirs provide controlled and sustained release of sirolimus, with an extended release profile similar to that of a drug-eluting stent. Preclinical animal data showed therapeutic levels of sirolimus in tissue for > 60 days, and first-in-human clinical trial results in peripheral arteries demonstrated a late lumen loss of 0.19 mm.