Fondazione Ricerca e Innovazione Cardiovascolare Completes Enrollment in TRANSFORM II RCT, A landmark study comparing MagicTouch SCB vs DES in Native Coronary Vessels

Prof. Bernardo Cortese, Study Chairman of TRANSFORM II, commented: "After 3 and a half years we were able to complete the enrollment in TRANSFORM II trial, a study that involved 52 centers across 3 continents, and this is amazing. The effort put by our Team in Fondazione RIC and each Investigator of the study led to a quite fast enrollment in such a big, ambitious study. Our goal is to advance the adoption of DCB in the coronary space, testing this sirolimus DCB with the most studied and used DES, in a daily patient population. Along with the guidance of the recently published DCB ARC guidelines, we are paving the route for the modern angioplasty era!".

CLEVELAND, 13/06/2025 (informazione.news - comunicati stampa - salute e benessere)

, Study Chairman of TRANSFORM II, commented: .

Coronary vessels of this size (which account for roughly 80% of patients undergoing percutaneous coronary interventions) present unique treatment challenges. Currently, interventional cardiologists must often choose a permanent implant namely a drug-eluting stent — effectively "caging" a small vessel — which may compromise long-term outcomes. The head-to-head comparison of MagicTouch SCB against a current standard of care (the EES family of drug-eluting stents) in TRANSFORM II is poised to provide critical evidence for an alternative approach. This trial has the potential to reshape treatment practices by establishing drug-coated balloons as the next viable option for patients with coronary artery disease.

Drug-coated balloon technology has long been viewed as a promising solution for small, de-novo coronary lesions, and sirolimus is a viable alternative to the first generation of DCB eluting paclitaxel. Data from this large-scale RCT are expected to support a paradigm shift towards broader use of drug-coated balloons. Implanting a drug-eluting stent in a tiny artery is far from ideal for both patients and physicians, so a rigorous study validating the use of SCB was needed. TRANSFORM II is set to fulfill that need, with initial 12-month outcomes anticipated to shed light on the long-term benefits of avoiding permanent implants in coronary vessels.

Dr. Manish Doshi , Founder & Managing Director of Concept Medical Group, commented:

The MagicTouch SCB, developed by Concept Medical Inc., utilizes proprietary Nanoluté technology to deliver sub-micron particles of sirolimus encapsulated in a biocompatible carrier, ensuring deep penetration into the vessel wall. The device has received CE Mark approval in Europe alongwith Breakthrough Device Designation & IDE Approval from the U.S. FDA for the treatment of small coronary vessels and in-stent restenosis with ongoing clinical trials.

Concept Medical Inc., headquartered in Tampa, Florida , has a global presence and is dedicated to enhancing patient care through cutting-edge research and development of drug-delivery technologies. Its proprietary platforms are designed to deliver pharmaceutical agents across vascular luminal surfaces with unparalleled precision. Concept Medical is the developer of the MagicTouch family of Sirolimus-Coated Balloons (SCB) – the world's first and most utilized SCB technology – well recognized for its versatility and efficacy in treating coronary and peripheral artery disease. The revolutionary MagicTouch and Abluminus product lines have been used to treat over a million patients globally, setting a new standard for vascular therapy.

For more information, please visit .

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