Concept Medical's MAGICAL BTK IDE Trial Welcomes First Patient in USA, Advancing Peripheral Arterial Disease Treatment
In a groundbreaking advancement for the treatment of peripheral artery disease (PAD), Concept Medical Inc. proudly announces the enrollment of the first patient in its MAGICAL BTK investigational device exemption (IDE) trial. This clinical study focuses on the effectiveness of the MagicTouch PTA, a drug-coated balloon technology designed to improve patient outcomes for those suffering from below-the-knee arterial disease. Enrolled by Dr. Prakash Krishnan and his team at Mount Sinai's Icahn School of Medicine, this milestone paves the way for innovative treatment options in vascular health.
The recent approval by the U.S. Food and Drug Administration (FDA) for the use of MagicTouch PTA has opened the doors to clinical trials within the United States, and the initiation of the MAGICAL BTK trial marks a significant moment in this journey. With this trial, Concept Medical aims to evaluate the safety and efficacy of the sirolimus-coated MagicTouch PTA balloon compared to standard percutaneous transluminal angioplasty (PTA).
"The enrollment of the first patient in the MAGICAL BTK trial highlights a critical step toward enhancing the standard of care for patients with below-the-knee PAD," said Dr. Krishnan. He emphasized the potential of sirolimus-coated balloon technology to significantly improve limb recovery and overall patient quality of life. This study is pivotal as it focuses on clinically meaningful outcomes related to patients' health and mobility.
The MAGICAL BTK trial aims to assess primary patency at the 12-month mark, ensuring that significant clinical results are prioritized. Coordinated by an esteemed panel of leading researchers, including Professor Sahil Parikh, the study gathers insights from various healthcare professionals specializing in vascular treatments.
Professor Parikh expressed enthusiasm about the trial's launch, stating, "This represents a new era in treating chronic limb ischemia, offering hope to millions facing the risk of limb loss due to poor arterial circulation." The advantages of the MagicTouch technology have been documented in numerous large-scale trials across Asia and Europe, demonstrating its transformative impact on the treatment of both peripheral and coronary artery diseases. Now, with the initiation of the MAGICAL BTK trial, patients in the U.S. can benefit from this innovative therapeutic approach.
Alongside the MAGICAL BTK trial, Concept Medical is also actively enrolling patients for the MagicTouch SCB trial addressing coronary artery disease, showcasing the company's commitment to advancing patient care across a spectrum of vascular concerns.
Dr. Manish Doshi, founder and CEO of Concept Medical, underscores the company's dedication to innovation, stating, "Our steadfast commitment to improving patient outcomes drives us to push the boundaries of what's possible in vascular interventions." The launch of MAGICAL BTK reinforces their mission to provide cutting-edge, evidence-based solutions to both healthcare providers and patients worldwide.
Furthermore, the trial's allowance for patient enrollment from Asia enhances the global cohort diversity, presenting a comprehensive understanding of the benefits of this therapy for various population demographics.
Concept Medical, headquartered in Tampa, Florida, is focused on elevating patient care through advanced drug delivery technologies. The firm is renowned for its cutting-edge drug-coated balloon products, like MagicTouch, which are utilized extensively in treating coronary and peripheral artery disease.
With over a million patients treated globally using the revolutionary MagicTouch and Abluminus product lines, Concept Medical continues to set new standards in vascular therapy. The ongoing MAGICAL BTK study, coupled with the MAGICAL SFA IDE study for superficial femoral artery treatment, positions Concept Medical at the forefront of endovascular care innovation.
For further information, please visit Concept Medical's official website at www.conceptmedical.com.
The recent approval by the U.S. Food and Drug Administration (FDA) for the use of MagicTouch PTA has opened the doors to clinical trials within the United States, and the initiation of the MAGICAL BTK trial marks a significant moment in this journey. With this trial, Concept Medical aims to evaluate the safety and efficacy of the sirolimus-coated MagicTouch PTA balloon compared to standard percutaneous transluminal angioplasty (PTA).
"The enrollment of the first patient in the MAGICAL BTK trial highlights a critical step toward enhancing the standard of care for patients with below-the-knee PAD," said Dr. Krishnan. He emphasized the potential of sirolimus-coated balloon technology to significantly improve limb recovery and overall patient quality of life. This study is pivotal as it focuses on clinically meaningful outcomes related to patients' health and mobility.
The MAGICAL BTK trial aims to assess primary patency at the 12-month mark, ensuring that significant clinical results are prioritized. Coordinated by an esteemed panel of leading researchers, including Professor Sahil Parikh, the study gathers insights from various healthcare professionals specializing in vascular treatments.
Professor Parikh expressed enthusiasm about the trial's launch, stating, "This represents a new era in treating chronic limb ischemia, offering hope to millions facing the risk of limb loss due to poor arterial circulation." The advantages of the MagicTouch technology have been documented in numerous large-scale trials across Asia and Europe, demonstrating its transformative impact on the treatment of both peripheral and coronary artery diseases. Now, with the initiation of the MAGICAL BTK trial, patients in the U.S. can benefit from this innovative therapeutic approach.
Alongside the MAGICAL BTK trial, Concept Medical is also actively enrolling patients for the MagicTouch SCB trial addressing coronary artery disease, showcasing the company's commitment to advancing patient care across a spectrum of vascular concerns.
Dr. Manish Doshi, founder and CEO of Concept Medical, underscores the company's dedication to innovation, stating, "Our steadfast commitment to improving patient outcomes drives us to push the boundaries of what's possible in vascular interventions." The launch of MAGICAL BTK reinforces their mission to provide cutting-edge, evidence-based solutions to both healthcare providers and patients worldwide.
Furthermore, the trial's allowance for patient enrollment from Asia enhances the global cohort diversity, presenting a comprehensive understanding of the benefits of this therapy for various population demographics.
Concept Medical, headquartered in Tampa, Florida, is focused on elevating patient care through advanced drug delivery technologies. The firm is renowned for its cutting-edge drug-coated balloon products, like MagicTouch, which are utilized extensively in treating coronary and peripheral artery disease.
With over a million patients treated globally using the revolutionary MagicTouch and Abluminus product lines, Concept Medical continues to set new standards in vascular therapy. The ongoing MAGICAL BTK study, coupled with the MAGICAL SFA IDE study for superficial femoral artery treatment, positions Concept Medical at the forefront of endovascular care innovation.
For further information, please visit Concept Medical's official website at www.conceptmedical.com.
Topics Health）
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