Concept Medical Announces First Patient Enrollment in the MAGICAL BTK IDE Trial, Launching its PAD Clinical Program in the United States

     "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."

TAMPA, Fla., 16/01/2025 (informazione.news - comunicati stampa - salute e benessere)

    

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 , with a distinguished panel of Principal Investigators including and

     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.

      said .

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.

, 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 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 and 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.

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