TAMPA, Florida., January 17, 2025 /PRNewswire/ — Concept Medical Inc.a global pioneer in innovative drug delivery technologies, is proud to announce the successful recruitment of the first patient in the “MAGICAL BTK” study (randomized controlled trial of MagicTouch PTA – Sirolimus Coated Balloon versus Standard Balloon Angioplasty in the treatment of arteries below the knee). disease) US Pivotal Investigational Device Exemption (IDE) Trial. The first patient was registered by Dr. Prakash KrishnanMDand his team at Icahn School of Medicine at Mount Sinaimarking a crucial step in advancing treatment options for patients suffering from below-the-knee peripheral artery disease (PAD).
Following the recent IDE approval by the United States Food and Drug Administration (FDA) for MagicTouch PTAthis recruitment announces the start of Concept Medical’s peripheral clinical trial program in the United States. With the IDE study underway for MagicTouch SCB In the area of coronary heart disease, Concept Medical is now actively participating in two clinical trials in the United States involving coronary and peripheral interventions, an unprecedented achievement aimed at improving patient outcomes and expanding treatment choices.
“Enrollment of the first patient in the MAGICAL BTK trial represents an important step forward toward improving the standard of care for below-the-knee disease in patients with peripheral artery disease,” said Dr. Prakash KrishnanMD, Icahn School of Medicine at Mount Sinai. “Sirolimus-coated balloon technology has the potential to significantly improve limb salvage and quality of life for patients. I am honored to be part of this landmark study and look forward to the meaningful clinical evidence it will generate.
The pivotal MAGICAL BTK trial is designed to evaluate the safety and effectiveness of the MagicTouch PTA sirolimus-coated balloon compared to standard percutaneous transluminal angioplasty (PTA) for the treatment of below-knee arterial disease. The primary endpoint, measured at 12 months, is primary patency, ensuring that trial results focus on meaningful clinical outcomes. This global, multicenter study is led by Prof. Sahil Parikh (President)with a distinguished panel of principal investigators, including Dr. Eric Secemsky (Beth Israel Deaconess Hospital and Harvard Medical School), Prof. Brian DeRubertis (Weill Cornell Presbyterian Medical Center of New York and Cornell University Medical College), Professor Edward Choke (Northern Heart Hospital), And Prof. Osamu Iida (Osaka Keisatsu Hospital).
“The launch 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 disease who are at risk of limb loss due to insufficient arterial circulation in their legs, “ declared Prof. Sahil Parikh.
Sirolimus-coated balloon technology has already reshaped the management of coronary and peripheral artery disease, with MagicTouch achieving positive results in large-scale trials across Asia And Europe.. Now, thanks to the MAGICAL BTK trial, American patients have the opportunity to benefit from this revolutionary approach. At the same time, the recruitment of patients Asia will expand the global patient cohort, providing a more comprehensive understanding of the therapy’s benefits in 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 procedures” said Dr. Manish Doshi (Founder and Managing Director). “The launch of MAGICAL BTK once again confirms our commitment to delivering next-generation, evidence-based solutions to clinicians and patients around the world. Our goal is to redefine current standards, ensuring better outcomes and quality of life for people affected by PAD.
With the start of the MAGICAL BTK and MAGICAL SFA IDE trials for the treatment of the superficial femoral artery (SFA), Concept Medical is poised to revolutionize endovascular care. The company’s distinctive technology platform has already improved the management of coronary heart disease, and now, by extending its reach to peripheral interventions, Concept Medical strengthens its leadership position in the advancement of drug delivery solutions patient-centered.
About Concept Medical
Concept Medical Inc.whose headquarters are at Tampa, Floridahas a global presence and is dedicated to improving patient care through cutting-edge research and development in drug delivery technologies. Its proprietary platforms are designed to deliver pharmaceutical agents to vascular luminal surfaces with unparalleled precision. Concept Medical is the developer of MagicTouch family of sirolimus-coated balloons (SCBs) — the first and most widely used SCB technology in the world — well recognized for its versatility and effectiveness in the treatment of coronary and peripheral arterial diseases. The revolutionary MagicTouch And Aluminum The product lines have been used to treat more than one million patients worldwide, setting a new standard in vascular therapy.
For more information, please visit www.conceptmedical.com.
SOURCE Medical Concept
