Latest news with #MagicTouch
Business Upturn
4 days ago
- Business
- Business Upturn
Concept Medical Announces First Patient Enrollment in MAGICAL-SV IDE Trial, Expanding its Coronary Clinical Program Across the U.S. and Europe
Concept Medical announces first patient enrollment in MAGICAL-SV IDE trial, expanding its Coronary Clinical Program across the U.S. and Europe. Business Wire India Concept Medical Inc. , a global pioneer in drug-delivery technologies, announced the enrollment of the first patient in the MAGICAL-SV (MAGIcTouch™ Sirolimus-Coated Balloon for Treatment of Coronary Artery Lesions in Small Vessels) trial, a U.S. Investigational Device Exemption (IDE) study evaluating its MagicTouch™ sirolimus-coated balloon (SCB) for the treatment of small coronary vessels. This first U.S. enrollment follows the FDA's IDE approval of MagicTouch SCB, marking a major milestone in Concept Medical's mission to revolutionize coronary artery disease (CAD) treatment and expand its clinical program into the US and Europe. Dr. Samin Sharma enrolled the first patient at New York's Mount Sinai Hospital, Director of Interventional Cardiology, marking a crucial step in advancing treatment options for patients with small-vessel coronary artery disease. 'Today marks a great feat for us and for the MAGICAL-SV trial,' said Dr. Samin Sharma. 'My team at Mount Sinai is privileged to be the first to begin this study. This is a proud moment for all of us, especially knowing what the trial signifies and aims to achieve by evaluating MagicTouch as a potential alternative for treating small vessels in the U.S.' Concept Medical is now actively enrolling in three IDE trials concurrently in the U.S., across coronary and peripheral interventions, underscoring its commitment to bringing innovative therapies to patients worldwide. MAGICAL-SV is a prospective, multicenter, single-blind randomized trial (2:1 randomization) comparing Concept Medical's MagicTouch sirolimus-coated balloon to DES (Everolimus eluting stents [EES] or Zotarolimus eluting stents [ZES]) for the treatment of small coronary artery lesions. Randomization is stratified by study site and presence of medically-treated diabetes mellitus status. The trial will enroll 1,605 patients across the U.S. and Europe, to evaluate the primary endpoint of target lesion failure (TLF) at 12 months. An international team of renowned cardiologists, Dr. Martin B. Leon (USA) – Study Chair, with principal investigators (PI) Dr. Azeem Latib (USA), Dr. Ajay Kirtane (USA), and Prof. Antonio Colombo (Europe) will lead the MAGICAL-SV trial. Dr. Azeem Latib, a U.S. PI for MAGICAL-SV, noted, 'The first U.S. patient enrollment in the MAGICAL-SV study marks an exciting step forward in building robust evidence for SCB technology in the treatment of small-vessel coronary disease. As we explore metal-free PCI strategies, this study brings renewed hope for safer, more effective options for our patients.' Prof. Antonio Colombo, who leads the European arm, added, 'Starting small and going big! MAGICAL-SV represents an important step in building evidence for sirolimus-coated balloons.' This milestone embodies a 'leave nothing behind' philosophy in coronary interventions, treating arterial blockages without permanent implants and addressing the limitations of metallic stents in small vessels. Dr. Martin B. Leon, the Study Chair, emphasized evaluating a no-stent strategy through this trial: 'The initiation of the MAGICAL-SV trial marks an important step in evaluating sirolimus-coated balloon therapy for small coronary vessels. By addressing key limitations of stenting in this complex anatomy, the study aims to generate strong comparative data versus DES. The results could inform future treatment strategies in the U.S. and Europe, offering clinicians a potential alternative for managing small-vessel disease.' The pioneering MAGICAL-SV trial aims to yield strong clinical evidence for sirolimus-coated balloon therapy, supporting Pre-Market Approval (PMA) for MagicTouch SCB in small vessels and potentially redefining CAD treatment. Dr. Manish Doshi, Founder and MD of Concept Medical, said, "MAGICAL-SV marks another step in our mission to redefine vascular care. We're focused on delivering next-generation solutions, helping clinicians achieve better outcomes and give CAD patients a better quality of life." For media inquiries contact: [email protected] Disclaimer: The above press release comes to you under an arrangement with Business Wire India. Business Upturn take no editorial responsibility for the same. Ahmedabad Plane Crash
Business Wire
4 days ago
- Business
- Business Wire
Concept Medical Announces First Patient Enrollment in MAGICAL-SV IDE Trial, Expanding its Coronary Clinical Program Across the U.S. and Europe
BUSINESS WIRE)-- Concept Medical Inc., a global pioneer in drug-delivery technologies, announced the enrollment of the first patient in the MAGICAL-SV (MAGI cTouch™ Sirolimus-Coated Balloon for Treatment of C oronary A rtery L esions in S mall V essels) trial, a U.S. Investigational Device Exemption (IDE) study evaluating its MagicTouch™ sirolimus-coated balloon (SCB) for the treatment of small coronary vessels. This first U.S. enrollment follows the FDA's IDE approval of MagicTouch SCB, marking a major milestone in Concept Medical's mission to revolutionize coronary artery disease (CAD) treatment and expand its clinical program into the US and Europe. Dr. Samin Sharma enrolled the first patient at New York's Mount Sinai Hospital, Director of Interventional Cardiology, marking a crucial step in advancing treatment options for patients with small-vessel coronary artery disease. 'Today marks a great feat for us and for the MAGICAL-SV trial,' said Dr. Samin Sharma. 'My team at Mount Sinai is privileged to be the first to begin this study. This is a proud moment for all of us, especially knowing what the trial signifies and aims to achieve by evaluating MagicTouch as a potential alternative for treating small vessels in the U.S.' Concept Medical is now actively enrolling in three IDE trials concurrently in the U.S., across coronary and peripheral interventions, underscoring its commitment to bringing innovative therapies to patients worldwide. MAGICAL-SV is a prospective, multicenter, single-blind randomized trial (2:1 randomization) comparing Concept Medical's MagicTouch sirolimus-coated balloon to DES (Everolimus eluting stents [EES] or Zotarolimus eluting stents [ZES]) for the treatment of small coronary artery lesions. Randomization is stratified by study site and presence of medically-treated diabetes mellitus status. The trial will enroll 1,605 patients across the U.S. and Europe, to evaluate the primary endpoint of target lesion failure (TLF) at 12 months. An international team of renowned cardiologists, Dr. Martin B. Leon (USA) - Study Chair, with principal investigators (PI) Dr. Azeem Latib (USA), Dr. Ajay Kirtane (USA), and Prof. Antonio Colombo (Europe) will lead the MAGICAL-SV trial. Dr. Azeem Latib, a U.S. PI for MAGICAL-SV, noted, 'The first U.S. patient enrollment in the MAGICAL-SV study marks an exciting step forward in building robust evidence for SCB technology in the treatment of small-vessel coronary disease. As we explore metal-free PCI strategies, this study brings renewed hope for safer, more effective options for our patients.' Prof. Antonio Colombo, who leads the European arm, added, 'Starting small and going big! MAGICAL-SV represents an important step in building evidence for sirolimus-coated balloons.' This milestone embodies a 'leave nothing behind' philosophy in coronary interventions, treating arterial blockages without permanent implants and addressing the limitations of metallic stents in small vessels. Dr. Martin B. Leon, the Study Chair, emphasized evaluating a no-stent strategy through this trial: 'The initiation of the MAGICAL-SV trial marks an important step in evaluating sirolimus-coated balloon therapy for small coronary vessels. By addressing key limitations of stenting in this complex anatomy, the study aims to generate strong comparative data versus DES. The results could inform future treatment strategies in the U.S. and Europe, offering clinicians a potential alternative for managing small-vessel disease.' The pioneering MAGICAL-SV trial aims to yield strong clinical evidence for sirolimus-coated balloon therapy, supporting Pre-Market Approval (PMA) for MagicTouch SCB in small vessels and potentially redefining CAD treatment. Dr. Manish Doshi, Founder and MD of Concept Medical, said, "MAGICAL-SV marks another step in our mission to redefine vascular care. We're focused on delivering next-generation solutions, helping clinicians achieve better outcomes and give CAD patients a better quality of life."
Yahoo
13-06-2025
- Business
- Yahoo
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 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 Photo: View original content to download multimedia: SOURCE Concept Medical Inc. View original content to download multimedia:
Yahoo
31-05-2025
- Entertainment
- Yahoo
Robin Thicke Marries April Love Geary After 6-Year Engagement
Robin Thicke and April Love Geary have tied the knot! PEOPLE can confirm that the longtime couple is officially married. The pair wed in Cabo San Lucas, Mexico, on Friday, May 30. Geary posted several clips and photos from the celebration on her Instagram Story. She wore an all-white dress, while Thicke wore a suit with a white flower in his lapel. One guest at the wedding published a video showing Thicke walking down the aisle to Leonard Cohen's "Hallelujah." Just days before the wedding, Thicke, 48, got down on one knee for a second time, popping the question to Geary, 30, again in Cannes. "Robin surprised me during our trip to Cannes by proposing to me again with a new ring that one of my best friends @nikkiwhatnikkiwho @establishedjewelry made, I'm so obsessed with it, thank you!!!😭 This trip was such a dream. 🤍 I love you so much @robinthicke Also a huge thank you to @alilasky for clearing out the whole area and making sure there wasn't a single person getting in the way," Geary shared on Instagram. Thicke and Geary, who share three children — son Luca Patrick, 2, and daughters Lola Alain, 4, and Mia Love, 6, began dating in 2014, several months after the singer separated from his wife of 10 years, Paula Patton. Two months after Thicke and Patton's divorce was finalized in March 2015, Thicke and Geary made their public debut as a couple at the Cannes Film Festival. The Grammy-nominated artist also shares son, Julian Fuego, 14, with ex-wife Paula Patton. In September 2016, the pair celebrated their second anniversary by getting matching tattoos on their ring fingers, sparking rumors that they had secretly wed, but a source told PEOPLE two months later they were not married. Never miss a story — sign up for to stay up-to-date on the best of what PEOPLE has to offer, from juicy celebrity news to compelling human interest stories. Thicke popped the question in December 2018. 'YES YES 1000x YES,' a pregnant Geary said at the time, sharing news of their engagement on social media. The model stood smiling in front of a Christmas tree as the 'Magic Touch' singer gave her a sweet smooch on the cheek for their Instagram announcement. She also included a video of Thicke proposing as the couple dined with loved ones. On April 24, Geary shared a black and white photo collage with Thicke on Instagram. "til the day we die 🤍" she captioned the images taken at the Malibu Beach House. Just weeks earlier, Geary gave a glimpse into dress shopping for her bridesmaids as she shared a carousel of images modeling different gowns. "Thank you so much @azaziebridal for the best day! My bridesmaids are so happy with their dresses! And thank you for letting me try on some dresses for fun 🤍 we honestly had so much fun and you guys went above and beyond. Thanks for taking care of all of us ♥️" she wrote. Read the original article on People
