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Medical Devices / Submissions and Approvals

FDA Grants Breakthrough Designation for Balloon Catheter

Aug. 14, 2019

Concept Medical’s MagicTouch PTA sirolimus drug-coated balloon catheter (DBC) has received the FDA’s breakthrough device designation for use below-the-knee.

The device is designed for treating peripheral artery disease, a common circulatory issue involving reduced blood flow from narrowed arteries, usually in the legs.

In an ongoing clinical study, the device was effective and there were no incidents of device and procedure-related mortality, the devicemaker said.

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