Concept Medical Launches Revolutionary MAGICAL BTK Clinical Trial for PAD Treatment in the US
Launch of the MAGICAL BTK Trial by Concept Medical
Concept Medical Inc., renowned for its cutting-edge drug delivery technology, recently made headlines with the enrollment of its first patient into 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) trial, indicating a major advancement in peripheral artery disease (PAD) treatment options. This pivotal moment took place at the Icahn School of Medicine at Mount Sinai, under the guidance of Dr. Prakash Krishnan, MD, who leads a dedicated team in this groundbreaking research effort.
The enrollment follows a significant approval from the U.S. Food and Drug Administration (FDA) for MagicTouch PTA, marking the official commencement of Concept Medical's clinical program targeting PAD in the United States. This trial stands alongside the company's existing IDE study focused on coronary artery disease, representing an unprecedented dual approach in clinical trials within the vascular intervention field.
Dr. Krishnan emphasized the importance of this enrollment, noting, "The initiation of the MAGICAL BTK trial represents a crucial step towards enhancing the standard of care for patients suffering from below-the-knee arterial disease. The use of Sirolimus-coated balloon technology may greatly improve limb salvage rates and the overall quality of life for patients. He expressed his honor at being part of this pioneering study that promises to yield valuable clinical insights.
The MAGICAL BTK trial will primarily assess the safety and efficacy of the MagicTouch PTA Sirolimus Coated Balloon compared to traditional angioplasty methods for treating below-the-knee arterial disease. Notably, the primary endpoint is focused on primary patency as measured over a 12-month period, ensuring that outcomes are clinically significant. The study is being conducted across multiple centers globally, led by a coalition of outstanding researchers.
Professor Sahil Parikh, chairperson of the trial, articulated the significance of the MAGICAL BTK study, stating, "The initiation of this trial marks a pivotal change in the treatment landscape for patients grappling with chronic limb-threatening ischemia. It offers renewed hope for the millions at risk of limb loss due to inadequate blood circulation in their lower extremities.”
The innovative technology developed by Concept Medical — specifically, the Sirolimus-coated balloon — has already transformed management strategies for coronary and peripheral artery diseases, with substantial positive outcomes documented in trials across Asia and Europe. U.S. patients will now have the opportunity to benefit from this new treatment protocol through the MAGICAL BTK trial, while patient enrollment in Asia will contribute to a robust global data set, offering a diverse insight into the therapy's efficacy.
Dr. Manish Doshi, the founder and managing director of Concept Medical, stated, “Our relentless pursuit of innovation in patient care propels us to extend the horizons of vascular interventions. The unveiling of the MAGICAL BTK trial validates our mission to provide next-generation, evidence-based solutions to both clinicians and patients globally.”*
Looking forward, the company plans to expand its clinical research horizon, with other trials like the MAGICAL SFA IDE trial for superficial femoral artery treatments also set to launch soon. Concept Medical aims to redefine the standards of endovascular care, making strides in both coronary and peripheral interventions and further solidifying its leadership position in producing patient-centric drug delivery technologies.
About Concept Medical
Headquartered in Tampa, Florida, Concept Medical Inc. is committed to enhancing patient care through innovative research and development in drug delivery technologies. The company's proprietary platforms excel in accurately delivering pharmaceutical agents across vascular luminal surfaces, establishing itself as a leader in creating effective solutions for artery disease treatment. The MagicTouch series of Sirolimus Coated Balloons (SCBs) is now recognized globally for its remarkable versatility and outcomes in vascular interventions, having been utilized in the treatment of over a million patients worldwide. For more detailed information, please visit their website at www.conceptmedical.com.
Topics Health）
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