Concept Medical Embarks on Revolutionary MAGICAL-SV Trial for Coronary Artery Disease

Concept Medical Inc., based in Tampa, Florida, has launched a groundbreaking study, the MAGICAL-SV trial, enrolling its first U.S. patient to evaluate the use of its advanced MagicTouch sirolimus-coated balloon against traditional drug-eluting stents for treating small coronary artery conditions.

The trial, approved as an Investigational Device Exemption (IDE) by the U.S. FDA, will involve 1,605 patients across the U.S. and Europe, aiming to offer an alternative to metallic stents in coronary interventions. Renowned cardiologists Dr. Martin B. Leon, Dr. Azeem Latib, and Prof. Antonio Colombo are leading the effort.

This research marks a significant advancement in coronary artery disease treatment by exploring a stent-free strategy which, if successful, could redefine treatment protocols and gain pivotal support for Concept Medical's Pre-Market Approval of the MagicTouch SCB.

(With inputs from agencies.)