Concept Medical Granted FDA Breakthrough Device Designation for MagicTouch PTA Sirolimus Coated Balloon

August 14, 2019

August 14, 2019 — Concept Medical Inc. (CMI) has been granted “Breakthrough Device Designation” from the U.S. Food and Drug Administration (FDA) for MagicTouch PTA, its sirolimus drug coated balloon (DCB) catheter, for the treatment of peripheral artery disease (PAD) in below-the-knee (BTK) applications.