MedAlliance SA has been granted Breakthrough Device Designation from the US Food and Drug Administration (FDA) for SELUTION, its sustained limus release (SLR) drug-coated balloon (DCB) catheter, for the treatment of coronary disease.
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 programme, the FDA will provide MedAlliance with priority review and interactive communication regarding device development and clinical trial protocols, through to commercialisation decisions.
“MedAlliance is honoured to have been selected for the FDA’s Breakthrough Device Program, which will allow US patients timely access to new technologies with the potential to provide safer and more effective treatment,” said Jeffrey B Jump, chairman and CEO of MedAlliance.
SELUTION’s technology involves unique micro-reservoirs made from biodegradable polymer intermixed with the anti-restenotic drug sirolimus. These micro-reservoirs provide controlled and sustained release of sirolimus. Extended release of sirolimus from stents has been demonstrated highly efficacious in both coronary and peripheral vasculatures. MedAlliance’s proprietary CAT (Cellular Adhesive Technology) enables the micro-reservoirs to be coated onto balloons and adhered to the vessel lumen when delivered via an angioplasty balloon.
MedAlliance is the first and only company able to deliver sirolimus in a DEB with an extended release profile similar to that of a drug-eluting stent (DES). Preclinical animal data shows therapeutic levels of sirolimus in tissue for greater than 60 days, and First in Man clinical trial results in peripheral arteries demonstrate a Late Lumen Loss of 0.19mm.
The FDA received the MedAlliance request to designate SELUTION as a Breakthrough Device in January 2019. The proposed indications for use included “improving luminal diameter, after pre-dilatation, in treatment of coronary artery ISR for stenotic lengths up to 36 mm with reference vessel diameters of 2.25 – 4.5 mm.” MedAlliance was recently informed by the FDA that “your combination product and proposed indication for use meet the criteria and have been granted designation as a Breakthrough Device”.
The goal of the Breakthrough Devices Program is to provide patients and healthcare providers with 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.
The Breakthrough Devices Program offers manufacturers an opportunity to interact with the FDA’s experts through several different program options to efficiently address topics as they arise during the premarket review phase, which can help manufacturers receive feedback from the FDA and identify areas of agreement in a timely way. Manufacturers can also expect prioritized review of their submission.