MedAlliance has been granted breakthrough device designation from the US FDA for Selution—a sustained limus release drug-coated balloon catheter for the treatment of coronary disease. The FDA breakthrough device programme 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.
A press release reports that Selution’s technology involves unique microreservoirs made from biodegradable polymer intermixed with the antirestenotic drug sirolimus. These microreservoirs 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 cellular adhesive technology, according to the press release, enables the micro-reservoirs 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 been selected for the FDA’s breakthrough device programme, which will allow US patients timely access to new technologies with the potential to provide safer and more effective treatment.
The press release states that MedAlliance is the first and only company able to deliver sirolimus in a drug-coated balloon with an extended release profile similar to that of a drug-eluting stent. Preclinical animal data shows therapeutic levels of sirolimus in tissue for greater than 60 days, and first-in-human 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 in-stent restenosis for stenotic lengths up to 36mm with reference vessel diameters of 2.25–4.5mm.