Concept Medical has announced the enrolment of the first patient in its MAGICAL-SV trial, a US Investigational Device Exemption (IDE) study assessing the MagicTouch Sirolimus-Coated Balloon (SCB) for treating small coronary artery lesions. The trial marks the company’s expansion into the United States and Europe with its coronary clinical programme.
The first patient was enrolled at Mount Sinai Hospital, New York, by Dr Samin Sharma, Director of Interventional Cardiology. Dr Sharma said, “Today marks a great feat for us and for the MAGICAL-SV trial. 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.”
Following the US FDA’s IDE approval, Concept Medical is conducting three IDE trials in the country across coronary and peripheral interventions. The MAGICAL-SV trial is a prospective, multicentre, single-blind randomised trial. It uses a 2:1 randomisation design to compare the MagicTouch SCB to drug-eluting stents (Everolimus Eluting Stents [EES] or Zotarolimus Eluting Stents [ZES]) in treating small coronary artery lesions.
Randomisation is stratified by study site and the presence of medically treated diabetes mellitus. The trial aims to enrol 1,605 patients across the US and Europe to evaluate the primary endpoint of Target Lesion Failure (TLF) at 12 months.
The study is chaired by Dr Martin B. Leon (USA), with principal investigators Dr Azeem Latib (USA), Dr Ajay Kirtane (USA), and Prof Antonio Colombo (Europe).
Dr Latib stated, “The first U.S. patient enrolment 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 Colombo added, “Starting small and going big! MAGICAL-SV represents an important step in building evidence for sirolimus-coated balloons.”
Dr Leon highlighted the aim of the study, saying, “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 trial’s approach aligns with a “leave nothing behind” strategy in coronary interventions, aiming to treat blockages without permanent implants.
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.”