#United States #Tampa #Concept Medical #PAD Treatment #Sirolimus Balloon

Concept Medical's Declared Launch of the MAGICAL BTK Trial

Overview

Concept Medical Inc., known for its innovative approach in drug delivery technology, has taken an essential step forward with the successful enrollment of the first patient in its MAGICAL BTK (Randomized Controlled Trial of MagicTouch PTA – Sirolimus Coated Balloon Versus Standard Balloon Angioplasty in the Treatment of Below The Knee arterial disease) pivotal trial in the United States. This milestone was achieved at the Icahn School of Medicine at Mount Sinai, where Dr. Prakash Krishnan led the enrollment on January 16, 2025.

Significance of the Trial

This trial is an essential component of Concept Medical’s broader clinical program aimed at addressing peripheral artery disease (PAD) below the knee. The Food and Drug Administration (FDA) recently granted Investigational Device Exemption (IDE) approval for the MagicTouch PTA device, paving the way for this significant clinical study. The MAGICAL BTK trial aims to explore the safety and effectiveness of the Sirolimus coated balloon compared to standard angioplasty procedures in patients dealing with this debilitating condition.

Dr. Krishnan stated, “Enrolling the first patient in the MAGICAL BTK trial represents a substantial advancement in the care standard for below-the-knee PAD patients. This Sirolimus-coated balloon technology shows considerable promise for enhancing limb preservation and improving patient quality of life.”

Study Design and Objectives

The primary focus of the MAGICAL BTK trial is to measure primary patency over a 12-month follow-up period. The study will involve a diverse group of participants and will utilize a global, multi-center approach, thereby broadening the understanding of this therapy's efficacy across different demographics.

Leading this multinational effort is Prof. Sahil Parikh as Chairperson, supported by a panel of prominent Principal Investigators, including:

• - Dr. Eric Secemsky (Beth Israel Deaconess Hospital)
• - Prof. Brian DeRubertis (NY Presbyterian Weill Cornell Medical Center)
• - Prof. Edward Choke (Northern Heart Hospital)
• - Prof. Osamu Iida (Osaka Keisatsu Hospital)

Prof. Parikh commented, “The initiation of the MAGICAL BTK Trial opens new avenues for treating chronic limb-threatening ischemia, giving hope to the many patients at risk of limb loss due to compromised blood circulation in their legs.”

Global Reach and Future Implications

Sirolimus-coated balloon technology has already transformed the landscape of coronary and peripheral artery disease management, boasting positive trial outcomes across Asia and Europe. The MAGICAL BTK trial will not only engage U.S. patients but is also set to include participants from Asia, thereby enhancing the global patient cohort and facilitating a more comprehensive understanding of this therapy's benefits.

Dr. Manish Doshi, the Founder and Managing Director of Concept Medical, emphasized the company's dedication to innovative vascular interventions, claiming, “Starting the MAGICAL BTK study reinforces our commitment to providing evidence-based solutions to both clinicians and patients worldwide, redefining standards, and offering better outcomes for those impacted by PAD.”

Alongside launching the MAGICAL BTK trial, Concept Medical is also set to begin its MAGICAL SFA IDE trial to further investigate treatments for superficial femoral artery (SFA) conditions.

Conclusion

Concept Medical stands at the forefront of advancing therapies for critical vascular conditions, and through its proprietary drug delivery systems and clinical research initiatives, it seeks to improve patient care significantly. The successful initiation of the MAGICAL BTK trial is a testament to this commitment and marks a promising turn in the treatment landscape for patients suffering from peripheral artery disease. For more information, visit Concept Medical's website.