Concept Medical’s MAGICAL BTK IDE Trial Begins Enrollment

January 16, 2025—Concept Medical Inc., announced the enrollment of the first patient in the pivotal MAGICAL BTK randomized controlled trial, which is being conducted in the United States under an FDA-approved investigational device exemption (IDE).

According to the company, the trial is evaluating the safety and efficacy of the company’s MagicTouch percutaneous transluminal angioplasty (PTA) sirolimus-coated balloon versus standard balloon angioplasty in the treatment of below-the-knee arterial disease. The trial’s primary endpoint is primary patency at 12 months.

Concurrent enrollment of patients in Asia will broaden the global patient cohort and provide a more comprehensive understanding of the MagicTouch PTA therapy’s benefits across diverse populations, advised the company.

Concept Medical stated that the global, multicenter MAGICAL BTK study is led by Sahil Parikh, MD, as Chairperson along with a panel of Principal Investigators that includes Eric Secemsky, MD; Brian DeRubertis, MD; Edward Choke, MBBS; and Osamu Iida, MD.

“The initiation 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 condition who are at risk for limb loss because of insufficient arterial circulation in their legs,” commented Dr. Parikh in the company’s press release.

The first patient in the trial was enrolled by Prakash Krishnan, MD, and his team at the Icahn School of Medicine at Mount Sinai in New York, New York, noted the company.

“The enrollment 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,” commented Dr. Krishnan in Concept Medical’s press release. “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.”

The press release noted that in addition to the MAGICAL BTK trial, the company is set to begin the MAGICAL SFA IDE trial for the MagicTouch PTA device in the treatment of the superficial femoral artery. The company is also actively enrolling an IDE study for the MagicTouch sirolimus-coated balloon in coronary artery disease. Peripheral and coronary artery disease management with MagicTouch has achieved positive results in large-scale trials across Asia and Europe, stated Concept Medical.