Fondazione Ricerca e Innovazione Cardiovascolare Completes Enrollment in TRANSFORM II RCT, A landmark study comparing MagicTouch SCB vs DES in Native 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 6th 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:
Comparative Arms: MagicTouch SCB vs. Everolimus-Eluting Stent (EES)
Patient Population: 1,832 patients with de-novo lesions in coronary arteries (vessel diameter >2.0 mm to ≤3.5 mm; lesion length ≤50 mm)
Primary Endpoint: Target Lesion Failure at 12 months, non-inferiority design
Follow-Up: Patients will be monitored for up to 60 months (5 years)
Sub-Study: Optical Coherence Tomography (OCT) imaging in 70 patients at 9 months to assess angiographic outcomes
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.
For more information, please visit www.conceptmedical.com.
Photo: https://mma.prnewswire.com/media/2709645/Transform_II.jpgLogo: https://mma.prnewswire.com/media/1926812/5120910/Concept_Medical_Logo.jpg
View original content to download multimedia:https://www.prnewswire.com/news-releases/fondazione-ricerca-e-innovazione-cardiovascolare-completes-enrollment-in-transform-ii-rct-a-landmark-study-comparing-magictouch-scb-vs-des-in-native-coronary-vessels-302481022.html
SOURCE Concept Medical Inc.
View original content to download multimedia: http://www.newswire.ca/en/releases/archive/June2025/13/c1967.html
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Fox News
2 hours ago
- Fox News
Vinegar face masks and barley water? Medieval 'health hacks' mirror today's TikTok trends
Historians recently unearthed some "health hacks" dating back to the Middle Ages v and some sound like they came straight off TikTok. The database, called the Corpus of Early Medieval Latin Medicine, offers a wealth of information about how people in the so-called "Dark Ages" viewed health, science and medicine. It was announced by Binghamton University in July. Meg Leja, an associate professor at the university, told Fox News Digital that she helped catalog hundreds of medieval medical texts, particularly focusing on all surviving Latin manuscripts up to the year 1000. "This means that we covered most of Continental Europe, but not England, where many early medieval medical writings were in the vernacular (i.e., Old English)," she said. "Because very few manuscripts survive from before the year 600, effectively our date range is 600 to 1000." Some of the cures, researchers said, could fit into in modern wellness circles. Below are six examples they found. Historians repeatedly came across a 12-month detox plan that included drinking herbs like cinnamon, sage, ginger and fennel – one for every month. The drinks were said to purge the body of buildup like mucus and "unwanted matter," much like modern juice cleanses. Another recipe in the database recommended a vinegar remedy "so that your face is radiant." "Grind wheat flour with vinegar [and] put this on as a plaster mixed with oil," the tip advises. Barley water occasionally pops up on TikTok as a "natural remedy" — and centuries before influencers promoted it, early medieval writers recommended its use. According to a text written before 1000 A.D., a healer claimed that mixing barley with hot wine would aid digestion. Other hacks were not TikTok-like at all, featuring ingredients that are both unpleasant and difficult to obtain. One text written before 1250 swore by dead vultures being a one-size-fits-all cure for a myriad of health issues. "You capture a vulture and decapitate it with a reed while saying 'Angel, Adonai Abraham, on your account the word is complete,'" the text advises. The dead bird's skull was said to prevent migraines, while its eyeballs "relieve pain of the eyes." Tying the vulture's feathers to a pregnant woman's legs was also said to help speed up labor. One late 9th-century tip – found in a priest's personal manuscript – suggested using green lizard ashes for fuller hair. "For flowing hair, cover the whole head with fresh summer savory and salt and vinegar," the translated instructions read. "[Then] rub it with the ashes of a burnt green lizard, mixed with oil." The most repulsive recipe, from an 11th-century text, offered the following tip for chest pain. "You dissolve goat dung in water and, sieved, you give it to drink," the tip advises. "It soon relieves the pain, however intensely it hurt." J. Matthew Knight, M.D., a board-certified dermatologist and Mohs surgeon, urged caution for those considering trying these cures. The Florida-based medical expert told Fox News Digital that, while barley, cinnamon and fennel may offer minor digestive benefits, the idea of detoxing over 12 months isn't backed by science. "When it comes to TikTok trends, or medieval remedies, there is painfully little to no scientific basis for their use." Knight, the founder of the Knight Dermatology Institute, also noted that the vinegar facial mask "could lead to irritant contact dermatitis," though vinegar has antibacterial effects. As for the more extreme remedies – like using goat dung for chest pain – the doctor warned they are "unsanitary and dangerous," and emphasized that anyone experiencing chest pain should go straight to the emergency room. Though Knight said he appreciates the novelty of the list, they exist "somewhere between funny and completely ineffective." For more Health articles, visit "All of these schemes predate the microscope, germ theory of disease and modern medicine, and rely on the idea that maladies were due to spiritual imbalance, moral transgression or cosmic forces," he told Fox News Digital. "Illness wasn't seen as bacterial or viral, but as a disturbance in unseen forces, like 'body humors.'" "Unfortunately, when it comes to TikTok trends, or medieval remedies, there is painfully little to no scientific basis for their use."
Yahoo
2 hours ago
- Yahoo
'Outstanding' new electric SUV achieves record-breaking safety score: 'We've raised the bar for ourselves'
Electric car manufacturer Lynk & Co. International recently shattered records with the highest-ever Euro NCAP safety score for a compact SUV, CleanTechnica reported. The European New Car Assessment Programme is an independent nonprofit organization that tests and rates automobiles on a five-star safety system. And Lynk & Co.'s 02, a fully electric compact SUV with a 200-kilowatt engine, clinched the spot as the safest vehicle in its class in 2025. "With outstanding results across all assessment categories — including the highest-ever recorded rating of 89% for Safety Assistance — the 02 is setting a new safety benchmark in its segment," CleanTechnica stated. The vehicle also achieved "outstanding" scores in Adult Occupant Protection, Child Occupant Protection, and Vulnerable Road User Protection. "Safety has always been a core pillar of our product strategy, and with the Lynk & Co. 02, we've raised the bar for ourselves — and for the entire segment," vice president of product and strategy David Green said in a news release. "This recognition reinforces our commitment to building vehicles that are not only innovative and sustainable but also among the safest on the road." Another often overlooked aspect of vehicular safety is air pollution, both inside and outside of the car — but it's one category wherein all electric vehicle models excel. That's because these vehicles don't burn oil for fuel, so they don't release the polluting gases that have been linked with severe health impacts and global heating. To put it in perspective, one MIT study found that diesel-burning cars emit nearly twice as much pollution per mile over their lifetimes than EVs — a difference of 350 grams of carbon dioxide per mile to 200. In addition to improved health and safety, many drivers are choosing to upgrade to EVs for the ease of ownership and lower costs. Since EVs don't have engines, they need far less expensive maintenance over their lifetimes. And obviously, they have no associated gasoline costs. Making the switch is a particularly savvy move for those with home solar panels, as charging a car with solar power brings both car and energy costs down to near zero. If you're interested in getting a quote from a vetted local installer, the free tools at EnergySage are a great place to start — using them helps the average person save up to $10,000 on a solar installation. Would you be more likely to get an EV if it came with a free home charger? Definitely Depends what the car costs Depends how fast it charges Not really Click your choice to see results and speak your mind. Join our free newsletter for weekly updates on the latest innovations improving our lives and shaping our future, and don't miss this cool list of easy ways to help yourself while helping the planet.
Associated Press
2 hours ago
- Associated Press
OCEANCO LAUNCHES LEVIATHAN -- A 111M / 364FT YACHT BUILT WITH INTENT, NOT CONVENTION
ZWIJNDRECHT, Netherlands, Aug. 10, 2025 /PRNewswire/ -- Oceanco is proud to introduce Leviathan, formerly known as project Y722, a 111m / 364ft diesel-electric yacht that redefines how we live and operate at sea. Designed not around tradition, but around purpose, Leviathan puts people at the heart of every decision. Built for an experienced owner with a deep commitment to team building and crew wellbeing, Leviathan represents a shift in how yachts are imagined, built, and run. From day one, crew were invited into the process – not just as operators, but lending their operational insights to shape a yacht that works better for those who run it. Materials and systems were chosen not to reduce effort, but to redirect effort toward higher-value work, not repetitive basic maintenance. Durable, ease of care materials like honed stone and natural wool carpets reduce upkeep, allowing crew to focus on the things that truly matter – whether it is creating richer guest experiences, supporting onboard scientific work, or managing complex operations in real time. Traditional high-maintenance elements like polished handrails with wooden cappings, teak decks and vast painted superstructure sections were intentionally replaced with smart alternatives such as composite capping rails / decks and full height glass superstructure bulkheads were seamlessly integrated, all without compromising but enhancing aesthetics. Leviathan's design reflects a human-centric approach to life at sea. With naval architecture by Lateral Naval Architects and Oceanco, exterior design by Oceanco, and interiors by Mark Berryman Design, every element has been developed to enhance functionality and comfort for both crew and guests. The owner played an active role throughout the process, alongside YTMC the owner's technical representatives, and ensuring the yacht remains aligned with its guiding philosophy. Crew and co-makers alike contributed their expertise – reflected in every practical detail and solution. As a tribute to the spirit of collaboration at the heart of this project, a glass panel engraved with the names of over 2,000 individuals involved in the build now stands in Leviathan's main staircase – a permanent reminder that this yacht was built by people, for people. 'Leviathan represents a new philosophy of yachting – one that places greater purpose at the heart of design, ownership and operations,' says Deniz de Koningh, Project Director at Oceanco. 'The owner's vision sets a forward-thinking example of how yachts can be built and used with intent. We are excited to see the influence she may have in shaping the future of the industry.' 'A sanctuary of comfort where silence meets strength, Leviathan wrapped in her sharp lines represents a superb synergy of form and function.' says Dan Morgan, Managing Director of YTMC. 'She is not just a high-performance vessel,' adds Charlie Birkett, CEO and Co-Founder of 'She is a working ecosystem, designed to support everything from world-class hospitality to scientific research. That is what happens when you put people and purpose, at the center.' Leviathan will begin sea trials in the coming weeks. More details about her capabilities and the philosophy behind her will be shared soon. SPECIFICATIONS CONTACT Georgia Lewis [email protected] Contact name: Paris Baloumis Contact phone: +31 78 69 95 399 Contact email: [email protected] Images and press kit link: View original content: SOURCE Oceanco
