Concept Medical has announced the enrolment of the first patient in the MAGICAL-SV trial, a US investigational device exemption (IDE) study evaluating its MagicTouch sirolimus-coated balloon (SCB) for the treatment of small coronary vessels, following US Food and Drug Administration (FDA) IDE approval.
Samin Sharma enrolled the first patient at New York’s Mount Sinai Hospital, marking a crucial step in advancing treatment options for patients with small-vessel coronary artery disease, the company said in a press release.
“Today marks a great feat for us and for the MAGICAL-SV trial,” said 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 USA.”
Concept Medical is now actively enrolling in three IDE trials concurrently in the USA, across coronary and peripheral interventions, underscoring its commitment to bringing innovative therapies to patients worldwide.
MAGICAL-SV is a prospective, multicentre, single-blind randomised trial (2:1 randomisation) comparing Concept Medical’s MagicTouch sirolimus-coated balloon to everolimus or zotarolimus drug-eluting stents (DESs) for the treatment of small coronary artery lesions. Randomisation is stratified by study site and presence of medically-treated diabetes mellitus status. The trial will enrol 1,605 patients across the USA and Europe, to evaluate the primary endpoint of target lesion failure (TLF) at 12 months.
The MAGICAL-SV trial aims to support premarket approval (PMA) for MagicTouch SCB in small vessels.
Study chair Martin B Leon (Columbia University, New York, USA), with principal investigators Azeem Latib (Montefiore Health Systems, New York, USA), Ajay Kirtane (Columbia University Irving Medical Center/NewYork-Presbyterian Hospital, New York, USA), and Antonio Colombo (San Raffaele Hospital, Milan, Italy) will lead the trial.
“The first USA patient enrolment 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,” said Latib. “As we explore metal-free PCI strategies, this study brings renewed hope for safer, more effective options for our patients.”
“Starting small and going big! MAGICAL-SV represents an important step in building evidence for sirolimus-coated balloons,” added Colombo, who leads the European arm of the trial.
“The initiation of the MAGICAL-SV trial marks an important step in evaluating sirolimus-coated balloon therapy for small coronary vessels,” comments Leon. “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 USA and Europe, offering clinicians a potential alternative for managing small-vessel disease.”
Manish Doshi, founder and managing director 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.”
