Tampa (Florida) [USA], August 4: Concept Medical Inc., a global pioneer in drug-delivery technologies, today 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 enrollment marks a major milestone in the company’s mission to revolutionize coronary artery disease (CAD) treatment and expands Concept Medical’s clinical program into the United States and Europe.

The first patient was enrolled at Mount Sinai Hospital in New York by Dr. Samin Sharma, 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 MagicTouchas a potential alternative for treating small vessels in the U.S.”

This initial U.S. enrollment follows the FDA’s IDE approval of Concept Medical’s MagicTouch SCB and boosts the company’s broader coronary clinical program. Concept Medical is now actively enrolling in three IDE trials concurrently in the U.S., spanning across coronary and peripheral interventions and 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 drug-eluting stents (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.

The MAGICAL-SV trial is led by an international team of renowned cardiologists, Dr. Martin B. Leon (USA) serves as Study Chair, with principal investigators (PI) Dr. Azeem Latib (USA), Dr. Ajay Kirtane (USA), and Prof. Antonio Colombo (Europe).

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 sirolimus-coated balloon 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 of the study, 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 the significance of 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.”

With this pioneering trial, MAGICAL-SV is expected to yield compelling clinical evidence in support of sirolimus-coated balloon therapy. The outcomes will also support Concept Medical’s Pre-Market Approval (PMA) application for the MagicTouch SCB in small-vessel indication, potentially transforming the standard of care in coronary artery disease.

Dr. Manish Doshi, Founder and Managing Director of Concept Medical, said, “At Concept Medical, our unwavering commitment to innovation and patient care drives us to push the boundaries of what is possible in vascular interventions. The initiation of MAGICAL-SV reinforces our dedication to delivering next-generation, evidence-based solutions to clinicians and patients across the globe. Our ultimate goal is to transform the current standard of care and provide better outcomes and quality of life for patients affected by CAD.”

About MagicTouch SCB

MagicTouch SCB is Concept Medical’s sirolimus-coated balloon platform, developed with proprietary Nanoluté technology to deliver sub-micron particles of sirolimus in a biocompatible carrier for deep arterial wall penetration. The device has received CE Mark approval in Europe and a Breakthrough Device designation from the U.S. FDA for small coronary vessels and in-stent restenosis.

About Concept Medical

Concept Medical Inc., headquartered in Tampa, Florida, is a global leader in cutting-edge drug-delivery technologies for cardiovascular interventions. The company is dedicated to improving patient care through research and development of novel drug-delivery platforms engineered to precisely deliver therapeutic agents to diseased vascular tissue. Concept Medical’s MagicTouch family of sirolimus-coated balloons is the world’s first and most widely used SCB technology, recognized for its versatility, safety and efficacy in treating coronary and peripheral artery disease. The revolutionary MagicTouch and Abluminus product lines have treated over one million patients worldwide, setting a new benchmark in vascular therapy.

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