Cleveland, Ohio, USA  June, 2025:  Fondazione Ricerca e Innovazione Cardiovascolare, the Lodi, Italy-based research foundation has announced the completion of patient enrolment for a trial evaluating the safety and effectiveness of Sirolimus-Coated Balloon (SCB) in comparison with the Drug-Eluting Stents.

The trial has enrolled a total of 1,832 patients from Europe, Asia and South America and designed to evaluate the safety and effectiveness of the MagicTouch Sirolimus-Coated Balloon (SCB) in comparison with the Everolimus-Eluting Stent (EES) in patients with De-Novo Coronary Artery Disease.

“After 3 and half years, we were able to complete the enrolment in TRANSFORM II trial, a study that involved 52 centers across 3 continents and will test this Sirolimus DCB with the most studied and used DES, in a daily patient population.” said Dr Bernardo Cortese, the Study Chairman.

The head-to-head comparison is undertaken to determine whether Drug-Coated Balloon technology can be widely adopted for primary treatment of small coronary lesions which currently accounts for nearly 80% of all Percutaneous Coronary Interventions.

Developed by Concept Medical, it delivers sub-micron particles of Sirolimus encapsulated in a biocompatible carrier, ensuring deep penetration into the vessel wall.

The device has obtained Breakthrough Device Designation from the US FDA for the treatment of Small Coronary Vessels and In-Stent Restenosis.