Concept Medical has secured breakthrough device designation from the US Food and Drug Administration (FDA) for its MagicTouch Percutaneous Transluminal Angioplasty (PTA) sirolimus drug-coated balloon (DCB).
The catheter is intended to treat patients with below-the-knee peripheral artery disease (PAD). It is based on the company’s Nanolute Technology sirolimus drug delivery platform.
MagicTouch PTA’s safety and efficacy are being assessed in a clinical study involving patients with below-the-knee arterial or femoropopliteal lesions.
Most of the participants suffer from diabetes and end-stage renal failure, and angioplasty was indicated for severe critical limb ischemia.
Study principal investigator Edward Choke noted that approximately 80% of the subjects did not have any patent below-the-knee arteries prior to angioplasty.
Choke added that Concept Medical’s device showed favourable profile, with 100% freedom from the device and procedure-related mortality and a 97% limb salvage rate at 30 days.
Freedom from clinically driven target lesion revascularization (TLR) was also recorded at 91% while primary patency evaluated using duplex ultrasound was 82% at six months.
Concept Medical plans to work with the FDA to further advance the MagicTouch PTA catheter.
A statement from the company read: “The breakthrough device designation granted to MagicTouch PTA offers Concept Medical an opportunity to interact with the FDA’s experts through several different programme 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.”
In April, the company also secured the FDA breakthrough device designation for MagicTouch sirolimus DCB to treat coronary in-stent restenosis (ISR). MagicTouch also holds the European CE-Mark.