Concept Medical Inc. has taken a major step in expanding its presence in the U.S. cardiovascular device market by enrolling the first patient in the MAGICAL-SV clinical trial. This pivotal study evaluates the company’s MagicTouch™ sirolimus-coated balloon (SCB) for the treatment of small coronary artery lesions—a complex area where conventional stents have limitations. The trial follows FDA approval under the Investigational Device Exemption (IDE) pathway and is part of Concept Medical’s mission to introduce a metal-free, drug-delivery-based solution for coronary artery disease (CAD).
The first U.S. patient was enrolled at Mount Sinai Hospital in New York by Dr. Samin Sharma, a leading interventional cardiologist. The MAGICAL-SV study is a prospective, multicenter, single-blind randomized trial comparing MagicTouch SCB with traditional drug-eluting stents (DES), including Everolimus and Zotarolimus eluting stents. With plans to enroll 1,605 patients across both the U.S. and Europe, the trial aims to generate strong comparative data on the primary endpoint of target lesion failure (TLF) at 12 months.
Led by globally recognized cardiologists—including Dr. Martin B. Leon (Study Chair), Dr. Azeem Latib (U.S. PI), Dr. Ajay Kirtane (U.S. PI), and Prof. Antonio Colombo (Europe PI)—the trial is positioned to build significant clinical evidence for sirolimus-coated balloon technology. As Concept Medical actively conducts three IDE trials in the U.S., the MAGICAL-SV study marks a milestone in their efforts to redefine interventional cardiology with a “leave nothing behind” philosophy, avoiding permanent metal implants in favor of safer, more adaptable therapies for patients with small-vessel CAD.
MAGICAL-SV trial begins U.S. enrollment for MagicTouch SCB in small vessels.
Study compares SCB vs DES in 1,605 patients across U.S. and Europe.
Part of Concept Medical’s broader push for metal-free coronary interventions.
