Latest news with #RCT
Korea Herald
13-06-2025
- Health
- Korea Herald
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.
Cision Canada
13-06-2025
- Business
- Cision Canada
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 /CNW/ -- 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: 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.
Yahoo
12-06-2025
- Business
- Yahoo
MCR Oil Tools Announces PHMSA Confirmation of Non-Explosive, Non-Hazmat Status For Shipment Of Its Thermite Tools
ARLINGTON, Texas, June 12, 2025 /PRNewswire/ -- MCR Oil Tools announced approval from PHMSA (Pipeline and Hazardous Materials Safety Administration), a division of the U.S. Department of Transportation, to transport the company's renowned thermite-based Radial Cutting Torches (RCT) as non-hazardous. The RCT is used worldwide for severing oil well pipe in pipe retrieval work on land and in deep water situations. The Fifth Circuit Court of Appeals ruled in July 2024 that PHMSA had in 2022 arbitrarily and capriciously designated MCR's Radial Cutting Torches (RCT's) as "explosives" without justification, apparently relying solely upon complaints from competitors. These complaints ignored factual evidence including test results from PHMSA's own thermite study as well as those from their own designated test labs. MCR tools have a pristine safety record of more than 40 years of global shipping without a single safety incident. And the Fifth Circuit Court of Appeals remanded the MCR thermite classification to PHMSA in October 2024 for further consideration. The PHMSA classification from 2022 is problematic in that hazardous and flammable materials can encounter shipping delays and require a notably greater amount of administrative paperwork which combine to increase costs for MCR and the oil and gas industry more broadly. PHMSA's authorization for MCR to ship its RCTs as non-explosive and non-hazardous recognizes the truly safe nature of MCR's technology and simplifies the continued distribution of MCR Torches to oil and gas producers and service firms around the world. Mike Robertson, Founder and C.E.O. of MCR Oil Tools, stated "We are pleased with the outcome of this lengthy and difficult period of struggle with PHMSA concerning the correct classification for our tools. We have always maintained product safety and will continue to do so while providing the most efficient pipe cutting technology for the energy industry." Mr. Robertson also stressed that PHMA's decision approving MCR to ship its RCT as non-hazmat vindicated the efforts of the company in the interest of its dozens of Licensees as well as the hundreds of producer customers around the world. MCR intends to rely upon the Fifth Circuit decision as well as the recent PHMSA action to pursue those who leveled false accusations against its proven safe tools. For More Information, please contact Pouya Mahbod Phone: 817 – 704 - 6678 Email: View original content: SOURCE MCR Oil Tools LLC Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Wales Online
05-06-2025
- Health
- Wales Online
Popular councillor resigns after being diagnosed with a brain tumour
Popular councillor resigns after being diagnosed with a brain tumour Dawn Wood said she has been forced to step down 'because of significant health challenges linked to a brain tumour' Dawn Wood has stepped down from her councillor roles (Image: Pontypridd Town Council ) A popular councillor has resigned due to ill health after being diagnosed with a brain tumour. Dawn Wood served as the RCT councillor for Pontypridd Town ward and Pontypridd Town councillor but had been absent from her roles since December 2024 for "medical reasons". She was elected as the Plaid Cymru councillor for Pontypridd Town in May 2022. Cllr Wood will be stepping down from both her roles with immediate effect. She said that it "was not an easy decision to make", adding that she was "devastated" to be making the announcement. "As many of you will be aware, I've had to take a period of absence from my role as both your RCT Councillor and Pontypridd Town Councillor for the past few months because of significant health challenges linked to a brain tumour," she said in a statement on Wednesday. "Thank you for all your kind words, support and understanding during this time. After careful consideration and consultation with my medical team, I have come to the difficult decision that I must step down from my role to focus on my health and wellbeing and have therefore tendered my resignation with immediate effect." She said serving the residents of Pontypridd Town Ward "has been one of the greatest honours" of her life. "I am deeply grateful for the trust and support that the community has shown me over the past three years. It has been a privilege to work alongside my fellow Plaid Cymru councillors and so many individuals, businesses and community groups to make a positive impact on our community." Cllr Ward explained that she had come to the difficult decision because of her "poor" prognosis. "Unfortunately, all avenues for treatment have been explored and my prognosis now is unfavourable, and is especially poor, if I were to continue in this role," she said. Article continues below "This was not an easy decision to make, but I hope you will understand why it is necessary." Get the latest Ponty news first by signing up to our newsletter here Cllr Ward spent nearly 30 years as a teacher before becoming a councillor and is also one half of the couple behind Between The Trees - a festival which combines indie folk music, art, and spoken word to inspire creativity and reconnect attendees with natural world. You can read more about this here. Cllr Ward's constituents and colleagues from across various parties thanked her for the work she had done. Labour MP for Pontypridd Alex Davies-Jones said: "I am very sorry to hear of Dawn Wood's resignation as councillor for Pontypridd Town Ward. "Although we come from different political parties, Dawn and I have worked closely together over the past few years, always with the shared goal of doing what's best for our community. I know this can't have been an easy decision, and I want to thank her for the time and commitment she gave to the role. "I'm thinking of her at this incredibly difficult time and wish her strength and all the very best for the future. She will be missed." Heledd Fychan, Plaid Cymru Ms for South Wales Central and Pontypridd Town Councillor said: "Cllr Dawn Wood has been an incredible colleague and champion for Pontypridd Town ward, and I'm saddened by this news. But as her friend, I'm fully supportive of her decision to prioritise her health. "Diolch am bopeth Dawn. You have been a bright light in our community and in the council chamber. If residents require support, I remain a representative on Pontypridd Town Council and as one of your Senedd Members. Please feel free to get in touch." One constituent wrote on Facebook: "Your health is the priority Dawn but thank you for all the support that you've given us and the wider community. You've been an asset." Another said: "Many thanks for all your hard work as our councillor. You have been very proactive and a real asset to Pontypridd town. Take care of yourself." A by-election is expected to be held to elect a replacement for the RCT council and Pontypridd Town Council seat in due course. Article continues below
Yahoo
02-06-2025
- General
- Yahoo
Need a ride to Final Fridays? Mansfield's free shuttle comes to your door
Richland County Transit will offer free rides for Final Fridays in downtown Mansfield. According to an announcement, the service will run from 6:30 p.m. to 11 p.m. on May 30, June 27, July 25, Aug. 29 and Sept. 26. RCT drivers will provide door-to-door rides in small buses, similar to Dial-A-Ride. The service area will include most of Lexington, Ontario and Madison Township, along with all of Mansfield. Rides must start or end at the pickup location on North Diamond Street near the Brickyard. To schedule a pickup, call RCT at 419-522-4504. Advance reservations are encouraged, but same-day requests may be accommodated based on availability. The Final Friday shuttle service is supported by RCT and the City of Mansfield. For more information, visit This story was created by Jane Imbody, jimbody@ with the assistance of Artificial Intelligence (AI). Journalists were involved in every step of the information gathering, review, editing and publishing process. Learn more at or share your thoughts at with our News Automation and AI team. This article originally appeared on Mansfield News Journal: Free door-to-door rides offered for Mansfield's Final Fridays
