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May 29, 2023
Concept Medical’s MagicTouch Sirolimus-Coated Balloon Granted IDE for SFA Treatment
May 29, 2023—Concept Medical Inc. announced that the FDA granted an investigational device exemption (IDE) approval for study of the company’s Magic Touch percutaneous transluminal angioplasty (PTA) sirolimus-coated balloon (SCB) for the treatment of peripheral artery disease in the superficial femoral artery (SFA).
According to the company, the IDE will allow Concept Medical to initiate a pivotal clinical trial to demonstrate the safety and effectiveness of the Magic Touch PTA device in the femoral and popliteal segments. The data generated from the study will support a future premarket approval application to the FDA for device approval in the United States.
Concept Medical noted that this is the fourth IDE approval for the Magic Touch portfolio, which previously received IDE approvals for coronary in-stent restenosis, coronary small vessel, and below-the-knee (BTK) indications.
The company advised that the Magic Touch PTA SCB has received European CE Mark approval and is commercially marketed outside the United States for the treatment of de novo, stenotic, and in-stent restenotic lesions in the SFA, popliteal, BTK, and iliac arteries using Concept Medical’s Nanoluté technology.
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