#USA #Cleveland #Concept Medical #MagicTouch SCB #TRANSFORM II

Completion of Patient Recruitment in TRANSFORM II Study

The Fondazione Ricerca e Innovazione Cardiovascolare is proud to announce the completion of patient recruitment for the TRANSFORM II randomized controlled trial (RCT), led by principal investigator Dr. Bernardo Cortese from the University Hospitals Harrington Heart & Vascular Institute in Cleveland, USA. This landmark study aims to compare the efficacy of the MagicTouch Sirolimus Coated Balloon (SCB) against the established Everolimus Eluting Stent (EES) in patients with de novo coronary lesions.

Having successfully enrolled 1,832 patients across 52 centers in Europe, Asia, and South America, the trial reached its target on June 6, 2025. Dr. Cortese expressed his pride in completing the recruitment, highlighting the collaborative effort of the research team and institutions involved.

Key Features of the TRANSFORM II Study

• - Study Design: A randomized controlled trial comparing MagicTouch SCB to EES.
• - Participant Demographics: Involving patients with de novo lesions in coronary arteries, specifically those with diameters greater than 2.0 mm and less than or equal to 3.5 mm, and lesion lengths up to 50 mm.
• - Primary Endpoint: Target lesion failure at 12 months, assessed using a non-inferiority model.
• - Follow-Up: Participants will be monitored for a total of 60 months (5 years).
• - Sub-Study: Optical coherence tomography will be employed for angiographic assessment in 70 patients after 9 months.

The aim of TRANSFORM II is not only to evaluate safety and efficacy but also to potentially shift treatment practices in interventional cardiology. Dr. Cortese emphasized the need to improve patient outcomes by minimizing the need for permanent implants, which can compromise long-term results.

The MagicTouch SCB is considered a game-changing technology that could provide a viable alternative to the current standard of care (EES), particularly in treating small vessel lesions, which constitute about 80% of patients undergoing percutaneous coronary interventions. These types of procedures often lead to challenging decisions regarding treatment options, making this comparison crucial. The transition towards a more feasible option like the Sirolimus-coated balloon could reshape existing treatment paradigms.

Innovative Technology Behind MagicTouch SCB

Developed by Concept Medical Inc., the MagicTouch SCB utilizes a proprietary technology called Nanolute to deliver sirolimus encapsulated in a biocompatible matrix, allowing deep penetration into the vessel wall. This device has already received the CE mark approval in Europe and holds Breakthrough Device Designation along with Investigational Device Exemption (IDE) from the FDA for treating small coronary vessels and stent restenosis.

This large-scale RCT offers a critical perspective on the potential of drug-coated balloons in the landscape of cardiovascular interventions, supporting a paradigm shift towards enhanced therapeutic options.

Dr. Manish Doshi, the founder and CEO of Concept Medical Group, stated that the completion of patient recruitment in TRANSFORM II is a significant milestone that reflects their commitment to advancing interventional cardiology through cutting-edge drug delivery technologies.

Conclusion

In conclusion, the initiation of results tracking for the TRANSFORM II trial marks a promising advancement for the future of cardiac interventions. By rigorously evaluating the effectiveness of the MagicTouch SCB, this study could lead to a broader acceptance of drug-coated balloon technologies, ultimately improving outcomes for patients globally suffering from coronary artery disease. For further details about this innovative study and the technology, visit Concept Medical.