Atherosclerosis

TAMPA, Fla., Jan. 20, 2025 /PRNewswire/ -- Concept Medical Inc. (CMI), a global leader in innovative drug-delivery technology across vascular interventions, proudly announces the successful completion of patient enrolment in the SirPAD Trial, with over 1,250 patients now enrolled. Continue Reading Concept Medical proudly announces that over 1,250 patients have successfully enrolled in the SirPAD Trial. The SirPAD (Major adverse limb events in patients with femoro-popliteal and below-the-knee peripheral arterial disease treated with either sirolimus-coated or uncoated balloon) randomised controlled trial is the world's largest study evaluating the treatment of Peripheral Artery Disease (PAD) using the MagicTouch PTA Sirolimus Coated Balloon (Concept Medical Inc.) versus uncoated balloons and one of the largest device studies ever performed for PAD. More than 1,250 patients have been enrolled and will be followed up at 12 months to assess the primary outcome of major adverse limb events (MALE). Final results are expected by Q1-Q2 2026. SirPAD is an investigator-initiated, multi-centre, randomized, open-label trial that aims to determine whether the MagicTouch PTA sirolimus-coated balloon is non-inferior to plain old balloon angioplasty (POBA). The trial will also explore the potential for superiority. Principal Investigators Prof. Dr. med. Nils Kucher and Prof. Dr. med. Stefano Barco, from the University Hospital Zurich, who leads this ambitious study, said, "Sirolimus-coated balloons represent a promising technology in treating symptomatic PAD, supported by evidence primarily from studies with surrogate endpoints. While trials like SIRONA and ongoing studies such as SirPAD are expanding knowledge, robust data from randomized controlled trials with clinical outcomes are needed to guide treatment and shape future guidelines. This result, having been able to randomize so many patients in a PAD device study, is unprecedented and we are very thankful to all investigators and patients for having supported the trial" on achieving the significant milestone of enrolling 1,250+ patients and successfully completing this phase of the study. With sirolimus-coated balloons gathering global momentum and MagicTouch PTA at the forefront, SirPAD is a crucial milestone in expanding the evidence for PAD treatment options. While patients with PAD have limited therapeutic avenues, SirPAD aims to bolster data supporting sirolimus-coated balloon technology. This large RCT was critical to evaluating treatment alternatives, and its year-long follow-up will provide much-anticipated answers. "At Concept Medical, we are committed to generating robust clinical evidence to support our innovative technologies. Following the successful completion of SIRONA—the largest superficial femoral artery (SFA) trial comparing our device against paclitaxel drug-coated balloons (DCBs), which demonstrated non-inferiority—we are proud to announce the completion of enrollment for another historical milestone: the largest randomised clinical trial for peripheral all-comers patients, completed enrolment of 1250+ patients. With this achievement, Concept Medical continues to lead the way with the most extensive and advanced clinical trial program in the field, reinforcing our position as a global pioneer in patient-centric vascular innovations," said Dr. Manish Doshi, Founder & Managing Director of Concept Medical. About Concept Medical 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 (SCBs)—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: Logo: SOURCE Concept Medical WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

TAMPA, Fla., Jan. 16, 2025 /PRNewswire/ -- Concept Medical Inc., a global pioneer in innovative drug delivery technology, is proud to announce the successful enrolment of the first patient in the "MAGICAL BTK" (Randomized Controlled Trial of MagicTouch PTA – Sirolimus Coated Balloon Versus Standard Balloon Angioplasty in the Treatment of Below The Knee arterial disease) U.S. Investigational Device Exemption (IDE) pivotal trial. The first patient was enrolled by Dr. Prakash Krishnan, MD, and his team at the Icahn School of Medicine at Mount Sinai, marking a crucial milestone in the advancement of treatment options for patients suffering from peripheral artery disease (PAD) below the knee. Continue Reading First patient enrollment in MAGICAL-BTK IDE Study in the United States. Following the recent IDE Approval by the U.S. Food and Drug Administration (FDA) for MagicTouch PTA, this enrolment heralds the beginning of Concept Medical's peripheral clinical trial program in the United States. With the ongoing IDE study for MagicTouch SCB in coronary artery disease, Concept Medical is now actively enrolling in two U.S. clinical trials in both coronary and peripheral interventions—an unprecedented achievement aimed at improving patient outcomes and expanding therapeutic choices. "The enrolment of the first patient in the MAGICAL BTK trial represents an important stride toward improving the standard of care for below-the-knee disease in patients with peripheral artery disease," said Dr. Prakash Krishnan, MD, Icahn School of Medicine at Mount Sinai. "Sirolimus-coated balloon technology has the potential to significantly enhance limb salvage and patient quality of life. I am honored to be part of this landmark study and look forward to the meaningful clinical evidence it will generate." The MAGICAL BTK pivotal trial is designed to evaluate the safety and effectiveness of MagicTouch PTA Sirolimus Coated Balloon compared to standard percutaneous transluminal angioplasty (PTA) for the treatment of below-the-knee arterial disease. The primary endpoint, measured at 12 months, is primary patency, ensuring that the trial's findings focus on meaningful clinical outcomes. This global, multi-center study is led by Prof. Sahil Parikh (Chairperson), with a distinguished panel of Principal Investigators including Dr. Eric Secemsky (Beth Israel Deaconess Hospital and Harvard Medical School), Prof. Brian DeRubertis (NY Presbyterian Weill Cornell Medical Center and Cornell University Medical College), Prof. Edward Choke (Northern Heart Hospital), and Prof. Osamu Iida (Osaka Keisatsu Hospital). "The initiation of the MAGICAL BTK Trial heralds a new era in the treatment of patients with chronic limb-threatening ischemia and offers hope to the millions of patients with this condition who are at risk for limb loss because of insufficient arterial circulation in their legs," stated Prof. Sahil Parikh. Sirolimus-coated balloon technology has already reshaped coronary and peripheral artery disease management, with MagicTouch achieving positive results in large-scale trials across Asia and Europe.. Now, with the MAGICAL BTK trial, U.S. patients have the opportunity to benefit from this breakthrough approach. Concurrently, patient enrolment from Asia will broaden the global patient cohort, offering a more comprehensive understanding of the therapy's benefits across diverse populations. "At Concept Medical, our unwavering commitment to innovation and patient care drives us to push the boundaries of what is possible in vascular interventions," said Dr. Manish Doshi (Founder & Managing Director). "The start of MAGICAL BTK further validates our dedication to bringing next-generation, evidence-based solutions to clinicians and patients worldwide. Our goal is to redefine current standards, ensuring better outcomes and improved quality of life for those affected by PAD." With the MAGICAL BTK trial and the MAGICAL SFA IDE trial for superficial femoral artery (SFA) treatment set to begin, Concept Medical is poised to revolutionise endovascular care. The company's distinctive technology platform has already elevated the management of coronary artery disease, and now, by expanding its reach into peripheral interventions, Concept Medical reinforces its leading position in advancing patient-focused, drug-delivery solutions. About Concept Medical 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 (SCBs)—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 - Logo - WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

BEAUFORT, S.C.--( BUSINESS WIRE )--A new report published by THE SAGE GROUP reviews recent calcium research and quantifies the number of CLI patients with calcified leg arteries. “Almost all CLI patients have arterial calcification. Calcification is associated with symptoms, increased amputation and higher mortality. In patients undergoing endovascular revascularization, the presence of calcium creates numerous challenges, including increased procedural complications,” stated Mary L. Yost, President. “Both intimal artery calcification (IAC) and medial artery calcium (MAC) are found in the lower limb arteries. While equally prevalent in the femoropopliteal and infrapopliteal arteries, the type of calcification varies by vascular territory. MAC is more prevalent in the arteries below-the-knee,” Yost elucidated. Characterized by severe linear vascular calcification, MAC is primarily found in the media but can also involve the intima. On plain X-rays, it shows up as a railroad track pattern. Located in the intima, IAC appears as dots or patchy areas of calcification. According to Ms. Yost, “Coronary artery calcium has been studied extensively. However, much less is known about calcium in the lower limbs. With the recent publication of studies investigating calcium in peripheral artery disease (PAD) patients, this knowledge gap has been reduced. In particular, research has focused on MAC, which predominates in the leg arteries, but not in the coronary arteries.” “MAC is now considered an independent cause of PAD,” Yost stated. “MAC, a nonatherosclerotic disease, is strongly associated with aging, diabetes and chronic kidney disease.” “In CLI patients, MAC predicts mortality, as well as major and minor amputation,” she continued. About the Report: Calcium in Peripheral Artery Disease: Characteristics, Consequences and Prevalence by Vascular Territory and by Type Of Calcium This report reviews the characteristics, consequences and prevalence of calcium in PAD and CLI. The prevalence and severity of calcium in CLI patients and limbs is estimated for the 2020-2040 period. The percent prevalence of calcium is estimated for three vascular territories: aortoiliac, femoropopliteal and infrapopliteal. Estimates by type of calcium, medial and intimal, in each vascular territory are included. Additional information: https://www.thesagegroup.us/reports/calcium-in-peripheral-artery-disease-characteristics-consequences-and-prevalence-by-vascular-territory-and-by-type-of-calcium/ THE SAGE GROUP, a research and consulting company, specializes in arterial and venous disease in the lower limbs. Additional information: www.thesagegroup.us .