Concept Medical announced the enrolment of the first patient in the MAGICAL-SV (MagicTouch Sirolimus-Coated Balloon (SCB) for the treatment of Coronary Artery Lesions in Small Vessels) trial. Investigational Device Exemption (IDE) study evaluating its MagicTouch Sirolimus-Coated Balloon (SCB) for the treatment of Small Coronary Vessels.
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 (CAD).
“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.”
This initial U.S. enrolment follows the FDA’s Investigational Device Exemption (IDE) approval of Concept Medical’s MagicTouch Sirolimus-Coated Balloon (SCB) and boosts the company’s broader coronary clinical programme. Concept Medical is now actively enrolling in three Investigational Device Exemption (IDE) trials concurrently in the U.S., spanning across coronary and peripheral interventions and underscoring its commitment to bringing innovative therapies to patients worldwide.
The MAGICAL-SV Investigational Device Exemption (IDE) trial is a prospective, multicenter, single-blind randomised trial (2:1 randomization) comparing Concept Medical’s MagicTouch Sirolimus-Coated Balloon (SCB) 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 enrol 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, with Dr. Martin B. Leon (USA) serving 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 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.”
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, emphasised 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 trial, MAGICAL-SV is expected to yield compelling clinical evidence in support of Sirolimus-Coated Balloon (SCB) therapy. The outcomes will also support Concept Medical’s Pre-Market Approval (PMA) application for the MagicTouch Sirolimus-Coated Balloon (SCB) in small-vessel indication, potentially transforming the standard of care in Coronary Artery Disease (CAD).
Dr Manish Doshi, Founder & Managing Director (MD) of Concept Medical said, “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.”