Tag: MagicTouch SCB

MagicTouch SCB receives IDE approval for In-Stent Restenosis indication

TAMPA, Fla., Sept. 17, 2022 /PRNewswire/ — The US FDA has granted an Investigational Device Exemption (IDE) approval for MagicTouch Sirolimus Coated Balloon (SCB) indicated for In-Stent Restenosis (ISR). US FDA’s IDE approval allows the MagicTouch SCB to be used in a pivotal clinical study to support safety and effectiveness of this combination product. The data generated […]

Small vessels can cause big problems; MagicTouch SCB Granted ‘Breakthrough Device Designation’ for the treatment of Small Coronary Artery Lesions

TAMPA, Fla., Dec. 17, 2020 /PRNewswire/ — Concept Medical Inc. (CMI) has been granted “Breakthrough Device Designation” from the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) for the MagicTouch SCB Sirolimus Coated Balloon Catheter, for the treatment of small coronary artery lesions in Coronary Artery Disease (CAD). The proposed […]