TRANSFORM II Study of Concept Medical’s MagicTouch SCB Completes Enrollment

June 16, 2025—Concept Medical Inc. recently announced the completion of enrollment in the TRANSFORM II randomized controlled trial (RCT). The study is evaluating the safety and efficacy of the company’s MagicTouch sirolimus-coated balloon (SCB) compared to an everolimus-eluting stent in treating de novo lesions in coronary vessels.

The company stated that the study has achieved its target enrollment of > 1,820 patients, with a total of 1,832 patients with de novo lesions in coronary arteries (vessel diameter, > 2.0 mm to ≤ 3.5 mm; lesion length ≤ 50 mm) treated at 52 centers across Europe, Asia, and South America.

As noted in the press release, the primary endpoint of the trial is target lesion failure at 12 months in a noninferiority design. Patients will be monitored for up to 60 months. In a substudy, angiographic outcomes will be assessed via optical coherence tomography imaging in 70 patients at 9 months, noted the company.

According to Concept Medical, TRANSFORM II is an investigator-driven trial sponsored by Fondazione Ricerca e Innovazione Cardiovascolare in Milan, Italy. The trial is led by Professor Bernardo Cortese, MD, of the University Hospitals Harrington Heart & Vascular Institute in Cleveland, Ohio.

The MagicTouch SCB has received CE Mark approval in Europe. In the United States, it has been granted Breakthrough Device designation by the FDA, as well as investigational device exemption approval for the treatment of small coronary vessels and in-stent restenosis within ongoing clinical trials, advised Concept Medical.