Concept Medical MagicTouch Sirolimus-Coated Balloon Receives IDE Approval for In-Stent Restenosis Indication

September 21, 2022—Concept Medical Inc. announced that the FDA has granted an investigational device exemption (IDE) approval for the company’s MagicTouch sirolimus-coated balloon (SCB) indicated for in-stent restenosis.

With the IDE approval, the company will conduct a pivotal clinical study of the safety and effectiveness of the MagicTouch SCB. The study data will support a premarket approval application to the FDA.

According to the company, the MagicTouch SCB, which features the company’s proprietary Nanoluté technology, has received CE Mark approval and is commercially available in Europe, major markets of Asia, and the Middle Eastern markets.