TAMPA, FLA. -- Concept Medical Inc., a global pioneer in drug-delivery technologies, announced the enrollment of the first patient in the MAGICAL-SV (MAGIcTouch™ Sirolimus-Coated Balloon for Treatment of Coronary Artery Lesions in Small Vessels) trial, a U.S. Investigational Device Exemption (IDE) study evaluating its MagicTouch™ sirolimus-coated balloon (SCB) for the treatment of small coronary vessels. This first U.S. enrollment follows the FDA’s IDE approval of MagicTouch SCB, marking a major milestone in Concept Medical’s mission to revolutionize coronary artery disease (CAD) treatment and expand its clinical program into the US and Europe.

Dr. Samin Sharma enrolled the first patient at New York’s Mount Sinai Hospital, Director of Interventional Cardiology, marking a crucial step in advancing treatment options for patients with small-vessel coronary artery disease.

“Today marks a great feat for us and for the MAGICAL-SV trial,” said Dr. Samin Sharma. “My team at Mount Sinai is privileged to be the first to begin this study. This is a proud moment for all of us, especially knowing what the trial signifies and aims to achieve by evaluating MagicTouch as a potential alternative for treating small vessels in the U.S.”

Concept Medical is now actively enrolling in three IDE trials concurrently in the U.S., across coronary and peripheral interventions, underscoring its commitment to bringing innovative therapies to patients worldwide.

MAGICAL-SV is a prospective, multicenter, single-blind randomized trial (2:1 randomization) comparing Concept Medical’s MagicTouch sirolimus-coated balloon to DES (Everolimus eluting stents [EES] or Zotarolimus eluting stents [ZES]) for the treatment of small coronary artery lesions. Randomization is stratified by study site and presence of medically-treated diabetes mellitus status. The trial will enroll 1,605 patients across the U.S. and Europe, to evaluate the primary endpoint of target lesion failure (TLF) at 12 months.

An international team of renowned cardiologists, Dr. Martin B. Leon (USA) - Study Chair, with principal investigators (PI) Dr. Azeem Latib (USA), Dr. Ajay Kirtane (USA), and Prof. Antonio Colombo (Europe) will lead the MAGICAL-SV trial.

Dr. Azeem Latib, a U.S. PI for MAGICAL-SV, noted, “The first U.S. patient enrollment in the MAGICAL-SV study marks an exciting step forward in building robust evidence for SCB technology in the treatment of small-vessel coronary disease. As we explore metal-free PCI strategies, this study brings renewed hope for safer, more effective options for our patients.”

Prof. Antonio Colombo, who leads the European arm, added, “Starting small and going big! MAGICAL-SV represents an important step in building evidence for sirolimus-coated balloons.”

This milestone embodies a “leave nothing behind” philosophy in coronary interventions, treating arterial blockages without permanent implants and addressing the limitations of metallic stents in small vessels. Dr. Martin B. Leon, the Study Chair, emphasized evaluating a no-stent strategy through this trial: “The initiation of the MAGICAL-SV trial marks an important step in evaluating sirolimus-coated balloon therapy for small coronary vessels. By addressing key limitations of stenting in this complex anatomy, the study aims to generate strong comparative data versus DES. The results could inform future treatment strategies in the U.S. and Europe, offering clinicians a potential alternative for managing small-vessel disease.”

The pioneering MAGICAL-SV trial aims to yield strong clinical evidence for sirolimus-coated balloon therapy, supporting Pre-Market Approval (PMA) for MagicTouch SCB in small vessels and potentially redefining CAD treatment.

Dr. Manish Doshi, Founder and MD of Concept Medical, said, “MAGICAL-SV marks another step in our mission to redefine vascular care. We’re focused on delivering next-generation solutions, helping clinicians achieve better outcomes and give CAD patients a better quality of life.”