Concept Medical trial: Concept Medical Inc. has officially launched its latest clinical study, enrolling the first patient in the MAGICAL-SV trial, an FDA-approved Investigational Device Exemption (IDE) study evaluating its MagicTouch™ sirolimus-coated balloon (SCB) for treating small coronary arteries.
The enrolment took place at Mount Sinai Hospital in New York, under the direction of Dr. Samin Sharma, Director of Interventional Cardiology. The trial expands Concept Medical’s coronary clinical research footprint across both the United States and Europe.
MAGICAL-SV (MAGIcTouch™ Sirolimus-Coated Balloon for Treatment of Coronary Artery Lesions in Small Vessels) will compare the performance of the MagicTouch SCB to commonly used drug-eluting stents (DES) in patients with small-vessel coronary artery disease, a condition that has traditionally posed challenges for stenting.
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The randomised, multicenter study will involve 1,605 patients and aims to evaluate the primary outcome of target lesion failure (TLF) at 12 months. Participants will be assigned in a 2:1 ratio to receive either the MagicTouch SCB or standard DES therapy, with patient selection stratified by site and diabetes status.
The trial is led by an international team of cardiology experts, including Study Chair Dr. Martin B. Leon and principal investigators Dr. Azeem Latib, Dr. Ajay Kirtane (both US), and Prof. Antonio Colombo (Europe).
Dr. Latib called the first US enrolment “an important step in generating strong clinical evidence for balloon-based, metal-free coronary intervention.” Prof. Colombo added that the trial could help establish sirolimus-coated balloons as a reliable alternative for complex coronary anatomies.
The MagicTouch SCB, built with Concept Medical’s proprietary Nanoluté™ technology, delivers sirolimus directly into the arterial wall without implanting a permanent device. The platform already holds CE Mark approval in Europe and FDA Breakthrough Device designation for use in small vessels and in-stent restenosis.
Dr. Manish Doshi, Founder and Managing Director of Concept Medical, said, “Launching MAGICAL-SV underscores our commitment to innovation in interventional cardiology. Our goal is to provide physicians with more advanced options and improve outcomes for patients with coronary artery disease.”
“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 US,” Dr. Shamin Sharma added. Findings from MAGICAL-SV are expected to support future FDA submissions and help redefine treatment strategies for small-vessel disease.
