Trial Commences for Concept Medical’s MagicTouch SCB in Small Vessels

August 4, 2025—Concept Medical Inc. recently announced the commencement of the MAGICAL-SV trial, which will enroll 1,605 patients across the United States and Europe.

According to the company, the study, conducted under an FDA investigational device exemption (IDE), is evaluating the company’s MagicTouch sirolimus-coated balloon (SCB) for the treatment of small coronary vessels.

The outcomes of the trial are expected to support Concept Medical’s premarket approval application to the FDA for the MagicTouch SCB in a small-vessel indication. The device has received CE Mark approval in Europe and Breakthrough Device designation from the FDA for small coronary vessels and in-stent restenosis.

The company advised that MAGICAL-SV is a prospective, multicenter, single-blind randomized (2:1) trial comparing Concept Medical’s MagicTouch SCB to drug-eluting stents (everolimus-eluting stent or zotarolimus-eluting stents) for the treatment of small coronary artery lesions. Randomization is stratified by study site and presence of medically treated diabetes mellitus status. The primary endpoint is target lesion failure at 12 months.

The MAGICAL-SV trial is led Study Chair Martin B. Leon, MD, with Principal Investigators Azeem Latib, MD, and Ajay Kirtane, MD, in the United States and Professor Antonio Colombo, MD, in Europe.

The first patient in the MAGICAL-SV trial was enrolled by Samin Sharma, MD, Director of Interventional Cardiology at Mount Sinai Hospital in New York, New York.

“Today marks a great feat for us and for the MAGICAL-SV trial,” commented Dr. Sharma in Concept Medical’s press release. “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 United States.”

Dr. Latib stated, “The first United States 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 percutaneous coronary intervention 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.”

Further, Dr. Leon emphasized the significance of evaluating a no-stent strategy through this trial, stating, “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 drug-eluting stents. The results could inform future treatment strategies in the United States and Europe, offering clinicians a potential alternative for managing small-vessel disease.”