January 14, 2020
FDA Grants Breakthrough Device Designation for MedAlliance’s Selution SLR Device for AVF Indications
January 14, 2020—MedAlliance announced that it has received FDA Breakthrough Device designation for the company's Selution SLR sirolimus-eluting balloon catheter for arteriovenous fistula indications.
In September 2019, the company announced that Selution SLR received Breakthrough Device designation for treating below-the-knee disease. The device has also received the designation for coronary in-stent restenosis.
The company advised that the FDA Breakthrough Device Program is intended to help patients receive more timely access to breakthrough technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions. Under the 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 timely access to these medical devices by speeding up their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and de novo marketing authorization, consistent with the agency’s mission to protect and promote public health.
According to MedAlliance, Selution SLR features microreservoirs made from biodegradable polymer intermixed with the antirestenotic sirloimus drug. The microreservoirs provide controlled and sustained release of the drug. MedAlliance’s CAT cell adherent technology enables the microreservoirs to be coated onto balloons and adhered to the vessel lumen when delivered via an angioplasty balloon.
In November 2019, MedAlliance announced “very encouraging” 2-year data from the first-in-human study of the Selution SLR sirolimus-eluting balloon that were presented by Professor Thomas Zeller, MD, the study’s Principal Investigator, at VIVA 2019, the Vascular InterVentional Advances meeting held November 4–7 in Las Vegas, Nevada. The study, which was composed of 50 patients enrolled at four German centers, confirmed the safety and efficacy of the device in treating lesions of the superficial femoral artery and popliteal artery over a prolonged period.