Concept Medical Inc (CMI) has been granted ‘Breakthrough Device Designation’ from the US Food and Drug Administration (FDA) for MagicTouch, its sirolimus drug-coated balloon (DCB) catheter, for the treatment of coronary in-stent restenosis (ISR).
In-Stent Restenosis (ISR) is the gradual re-narrowing of a stented coronary artery lesion, due to subsequent tissue proliferation at the stented site. ISR is observed in about 10% of patients who undergo a Drug-Eluting Stent (DES) implantation and in >30% of patients who undergo bare-metal stent (BMS) implantation. Such patients, who come back with reclogging of the coronary arteries following an earlier procedure of a bare metal or a drug-eluting stent implant, are candidates for treatment with the magic touch.
The goal of the FDA ‘Breakthrough Devices Program’ is to provide patients and healthcare providers in the US 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 a prioritized review of their submission. Under the program, FDA will provide CMI with priority review and interactive communication regarding device development and clinical trial protocols, through commercialization decisions.