Idea Medical Broadcasts First Affected person Enrollment in MAGICAL-SV IDE Trial, Increasing its Coronary Scientific Program Throughout the U.S. and Europe

TAMPA, Fla. — Idea Medical Inc., a worldwide pioneer in drug-delivery applied sciences, introduced the enrollment of the primary affected person within the MAGICAL-SV (MAGIcTouch™ Sirolimus-Coated Balloon for Remedy of Coronary Artery Lesions in Small Vessels) trial, a U.S. Investigational System Exemption (IDE) examine evaluating its MagicTouch™ sirolimus-coated balloon (SCB) for the therapy of small coronary vessels. This primary U.S. enrollment follows the FDA’s IDE approval of MagicTouch SCB, marking a significant milestone in Idea Medical’s mission to revolutionize coronary artery illness (CAD) therapy and increase its medical program into the US and Europe.

Dr. Samin Sharma enrolled the primary affected person at New York’s Mount Sinai Hospital, Director of Interventional Cardiology, marking an important step in advancing therapy choices for sufferers with small-vessel coronary artery illness.

Idea Medical is now actively enrolling in three IDE trials concurrently within the U.S., throughout coronary and peripheral interventions, underscoring its dedication to bringing modern therapies to sufferers worldwide.

is a potential, multicenter, single-blind randomized trial (2:1 randomization) evaluating Idea Medical’s MagicTouch sirolimus-coated balloon to DES (Everolimus eluting stents [EES] or Zotarolimus eluting stents [ZES]) for the therapy of small coronary artery lesions. Randomization is stratified by examine web site and presence of medically-treated diabetes mellitus standing. The trial will enroll 1,605 sufferers throughout the U.S. and Europe, to judge the first endpoint of goal lesion failure (TLF) at 12 months.

A world workforce of famend cardiologists, Dr. Martin B. Leon (USA) – Examine Chair, with principal investigators (PI) Dr. Azeem Latib (USA), Dr. Ajay Kirtane (USA), and Prof. Antonio Colombo (Europe) will lead the MAGICAL-SV trial.

This milestone embodies a “depart nothing behind” philosophy in coronary interventions, treating arterial blockages with out everlasting implants and addressing the restrictions of metallic stents in small vessels. Dr. Martin B. Leon, the Examine Chair, emphasised evaluating a no-stent technique by this trial: “The initiation of the MAGICAL-SV trial marks an vital step in evaluating sirolimus-coated balloon remedy for small coronary vessels. By addressing key limitations of stenting on this advanced anatomy, the examine goals to generate sturdy comparative knowledge versus DES. The outcomes may inform future therapy methods within the U.S. and Europe, providing clinicians a possible various for managing small-vessel illness.” The pioneering MAGICAL-SV trial goals to yield sturdy medical proof for sirolimus-coated balloon remedy, supporting Pre-Market Approval (PMA) for MagicTouch SCB in small vessels and doubtlessly redefining CAD therapy.

https://www.businesswire.com/information/house/20250804524652/en/

For media inquiries contact: pr@conceptmedical.com#distro