Concept Medical’s MagicTouch SCB Granted Breakthrough Device Designation for the Treatment of Small Coronary Artery Lesions

December 18, 2020—Concept Medical Inc. (CMI) has been granted Breakthrough Device designation by the FDA for the MagicTouch SCB, a sirolimus-coated balloon catheter for the treatment of coronary artery lesions in coronary artery disease (CAD).

According to the company, the proposed indication for use is for percutaneous transluminal coronary angioplasty, after appropriate vessel preparation, of small coronary artery lesion lengths of 6 to 36 mm in coronary arteries with reference vessel diameters of 1.50 to 2.75 mm.

The MagicTouch SCB catheter features CMI’s Nanolute technology for the treatment of small coronary artery lesions in coronary microvascular dysfunction (CMD). Nanolute technology is designed to improve the lipophilicity and bioavailability of sirolimus. CMD, which is the presence of angina with minimal or no angiographic CAD, can occur in both sexes but is more prevalent in women, especially after menopause, noted the company.

In May 2019, CMI announced that MagicTouch SCB was granted FDA Breakthrough Device designation for the treatment of coronary in-stent restenosis.

MagicTouch SCB has received European CE Mark approval and is commercially available in those countries that recognize CE Mark.