Fondazione Ricerca e Innovazione Cardiovascolare Completes Enrollment in TRANSFORM II RCT, A landmark study comparing MagicTouch SCB vs DES in Native Coronary Vessels
CLEVELAND, June 13, 2025 /PRNewswire/ -- Primary Investigator, Bernardo Cortese MD, proudly announces the successful completion of patient enrollment in the TRANSFORM II randomized controlled trial (RCT). This pivotal study aims to evaluate the safety and efficacy of the MagicTouch Sirolimus-Coated Balloon (SCB) compared to an everolimus-eluting stent (EES) in treating de-novo coronary vessels.
TRANSFORM II (Sirolimus-Coated Balloon Versus Drug-Eluting Stent in Native Coronary Vessels) is an investigator-driven trial sponsored by Fondazione Ricerca e Innovazione Cardiovascolare in Milano, Italy, and has now achieved its target enrollment of >1,820 patients. The final patient was enrolled on 6 th June 2025, marking a major milestone for the trial. Led by Study Chairman Prof. Bernardo Cortese (University Hospitals Harrington Heart & Vascular Institute, Cleveland, USA) and a distinguished steering committee, TRANSFORM II is one of the largest global randomized controlled trials evaluating drug-coated balloon and has enrolled patients from 52 centers across Europe, Asia and South America. Key features of the TRANSFORM II trial include:
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!".
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 completion of patient enrollment in TRANSFORM II is a significant milestone in our mission to bring innovative drug-delivery technologies to the forefront of interventional cardiology. We are proud to scientifically support one of the largest global randomized trials evaluating sirolimus-coated balloon technology. This achievement reflects our commitment to clinical excellence, scientific rigor, and ultimately, better outcomes for patients around the world."
About MagicTouch SCB
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.
About Concept Medical Inc.
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.
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About the Cochlear™ Nucleus® Nexa™ System The new system includes the Nucleus Nexa Implant, the Nucleus Kanso® 3 Nexa Sound Processor and the Nucleus 8 Nexa Sound Processor. The Nucleus Nexa Implant and sound processors are supported by Nucleus SmartNav, Nucleus Smart App, Custom Sound® Pro fitting software and wireless accessories. The new Nucleus® Nexa™ System can learn about its user's listening needs and the environment they are in. It can then automatically adjust listening or power management settings to help people hear more clearly [1] or maximise battery life. #* Users can enjoy clearer sound streamed directly from compatible* mobile devices and, in the future, at airports, concert venues and more using Bluetooth® LE Audio and Auracast™ broadcast audio. ¥ About Cochlear Limited (ASX: COH) People have always been Cochlear's inspiration, ever since Professor Graeme Clark set out to create the first multi-channel cochlear implant after seeing his father struggle with hearing loss. Since 1981, Cochlear has helped more than 700,000 people in more than 180 countries to hear. As the global leader in implantable hearing solutions, Cochlear connects people with life's opportunities, and welcomes them to the world's largest hearing implant community. Cochlear has a global workforce of more than 5,000 people, with a passion for progress, who strive to meet the needs of people living with hearing loss. The company continually innovates to anticipate future needs, investing more than AUD$3 billion to date in research and development to push the boundaries of technology and help more people hear. References and disclaimers Please seek advice from your health professional about treatments for hearing loss. Outcomes may vary, and your health professional will advise you about the factors which could affect your outcome. Always follow the directions for use. Not all products are available in all countries. Please contact your local Cochlear representative for product information. Views expressed are those of the individual. Consult your health professional to determine if you are a candidate for Cochlear technology. ± Smart cochlear implant system is defined as the first and only cochlear implant having Internal memory with upgradeable firmware. # Battery life varies for every user, according to the age of the battery, the programs used each day, your implant type, the thickness of skin covering your implant, and the size and type of battery used. Streaming from compatible devices, True Wireless Devices or FM may decrease sound processor battery life depending on how often and for how long streaming is engaged. * The Cochlear Nucleus 8 Nexa and Nucleus Kanso 3 Nexa sound processors are compatible with Apple and Android devices. For compatibility information and devices visit ¥ As Bluetooth LE Audio compatible devices become available, a firmware update will be required for you to use certain features. Auracast™ broadcast audio capability is subject to third party adoption of the Auracast protocol. The Bluetooth® and Auracast™ word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by Cochlear Limited is under license.
