The senior test doctor, Dr. Bernardo Cortese, reports the successful completion of the patient registration for the randomized controlled study (RCT) Transform II. The aim of this approval study is to the security and effectiveness of the Sirolimus-coated balloons (SCB) MagicTouch to examine in comparison to an everolimus-free stent (EES) in the treatment of de-Novo coronary vessels.
TRANSFORM II (Sirolimus-coated balloon Versus medication -coated stent in native coronary vessels) is a study sponsored by the Fondazione Ricerca e Innovazione Cardiovascolare in Milan, which has now reached the desired number of more than 1,820 patients. The last patient was registered on June 6, 2025 – an important milestone for the study. Under the leadership of the study manager Prof. Bernardo Cortese (University Hospital Harrington Heart and Vascular Institute, Cleveland, USA) and a respected steering committee, Transform II is one of the world’s largest randomized, controlled studies to evaluate the medication -coated balloons And took up patients from 52 centers in Europe, Asia and South America. The most important features of the transform II study include:
· Comparative arms: Magicttouch SCB vs. Everolimus-free stent (EES)
· Patientenpopulation: 1,832 patients with de-Novo lesions in coronary arteries (vascular diameter> 2.0 mm up to ≤3.5 mm; lesion length ≤50 mm)
· Primary end point: Failure of the targetsion after 12 months, non-subdue design
· Follow-up: The patients are monitored for up to 60 months (5 years).
· Partial study: Optical coherence tomography (OCT) in 70 patients after 9 months to evaluate the angiographic results
Prof. Bernardo CorteseStudy director of Transform II, commented: “After three and a half years we were able to complete the registration for the Transform II study in which 52 centers were involved in three continents-a remarkable success. The efforts of our team in the Fondazione Ric and every individual test doctor of the study led to a very quick admission to such a large, ambitious study. Our goal is to advance the introduction of DCB in the coronary area by Sirolimus-DCB with the best examined and most used in a daily patient population.
Coronary vessels of this size (which exist in about 80 % of the patients who undergo percutaneous coronary interventions) make special challenges for treatment. At the moment, interventional cardiologists often have to choose a permanent implant – a medication -free stent that “includes” a small container, which means that the long -term results can be affected. The direct comparison of Magicttouch SCB with the current treatment standard (the EES family of medication-free stents) As part of the transform II study, it is suitable to provide critical evidence for an alternative approach. This study has the potential to redesign treatment practice by establishing medication -coated balloons as the next practical option for patients with coronary heart disease.
The medication -coated balloon technology has long been considered a promising solution for small, newly created coronary lesions. Sirolimus is a possible alternative to the first generation of DCB that releases Paclitaxel. The data of this extensive RCT will be expected to move a paradigm shift towards a broader use of medication -coated balloons. The implantation of one Medicine -free stents In a tiny artery, anything but ideal for both patients and doctors, so that a stringent study was necessary to validate the use of SCB. Transform II should cover this need. The first 12-month results should provide information about the long-term advantages of avoiding permanent implants in the coronary arteries.
Dr. Manish Doshi, founder and Managing Director of the Concept Medical Groupcommented: “The conclusion of patient declaration for transform II is an important milestone for our mission to introduce innovative technologies for medication to medication at the forefront of the front front in interventional cardiology. Treatment results for patients around the world. “
Information about Magicttouch SCB
The developed by Concept Medical Inc. MagicTouch SCB Use the proprietary Nanoli-technology To submit sirolimus particles in the submicron area, which are encapsulated into a biocompatible carrier and ensure a deep penetration into the vascular wall. The device has received the CE approval in Europe as well as the Breakthrough Device Designation and the IDE approval by the US FDA for the treatment of small coronary vessels and in-stent ritosis and is currently being tested clinically.
Information about Concept Medical Inc.
Concept Medical Inc. The headquarters in Tampa, Florida, is a worldwide company that is committed to improving patient care through top research and development of technologies for medication administration. Its proprietary platforms are designed to transport pharmaceutical active ingredients with unprecedented precision via vascular lumen surfaces. Concept Medical is the developer of the Magict Touch family of Sirolimus-coated balloons (SCB)-the world’s first and most used SCB technology-which is known for its versatility and effectiveness in the treatment of coronary and peripheral arterial diseases. The revolutionary product lines Magictouch and Abluminus have already been used in over a million patients worldwide and have set a new standard for vascular therapy.
You can find more information at www.conceptmedical.com.
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