Sirolimus-Coated Balloon Gets IDE for Below-the-Knee Arterial Disease

Concept Medical has received an Investigational Device Exemption (IDE) from the FDA for its Magic Touch sirolimus coated balloon for treatment of below the knee (BTK) arterial occlusion disease.

The balloon is intended to prevent re-narrowing of superficial femoral and popliteal arteries of atherosclerotic lesions in patients with peripheral arterial disease, replacing the current standard of care, which is either a classic balloon, a paclitaxel coated balloon or a stent.

The device, which has already received FDA’s Breakthrough Device designation, is in a phase 3 trial to determine whether the balloon can maintain the patency of BTK arteries for a longer period. “This is a key goal in our efforts to reduce the number of repeated interventions and to save the legs of our patients with the severest form of peripheral arterial disease,” the company said.