Concept Medical has successfully enrolled the first patient in the MAGICAL BTK US investigational device exemption (IDE) pivotal trial, a press release reveals.
Following the recent IDE approval by the US Food and Drug Administration (FDA) for the MagicTouch PTA, this enrolment heralds the beginning of Concept Medical‘s peripheral clinical trial programme in the USA.
“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 arterial disease,” said Prakash Krishnan (Icahn School of Medicine at Mount Sinai, New York, USA), who enrolled the first patient. “Sirolimus-coated balloon technology has the potential to significantly enhance limb salvage and patient quality of life. I am honoured to be part of this landmark study and look forward to the meaningful clinical evidence it will generate.”
The MAGICAL BTK pivotal trial is designed to evaluate the safety and effectiveness of the MagicTouch PTA sirolimus-coated balloon compared to standard percutaneous transluminal angioplasty (PTA) for the treatment of below-the-knee (BTK) arterial disease. The primary endpoint, measured at 12 months, is primary patency.
This global, multicentre study is led by Sahil Parikh (Columbia University Irving Medical Center, New York, USA), with a panel of principal investigators including Eric Secemsky (Beth Israel Deaconess Hospital and Harvard Medical School, Boston, USA), Brian DeRubertis (NY Presbyterian Weill Cornell Medical Center and Cornell University Medical College, New York, USA), Edward Choke (Northern Heart Hospital, Georgetown, Malaysia), and Osamu Iida (Osaka Keisatsu Hospital, Osaka, Japan).
“The initiation of the MAGICAL BTK trial heralds a new era in the treatment of patients with chronic limb-threatening ischaemia 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,” stated Parikh.
A press release notes that sirolimus-coated balloon technology has already reshaped coronary and peripheral arterial disease management, with MagicTouch achieving positive results in large-scale trials across Asia and Europe. Now, with the MAGICAL BTK trial, US patients have the opportunity to benefit from this approach. Concurrently, the release continues, patient enrolment from Asia will broaden the global patient cohort, offering a more comprehensive understanding of the therapy’s benefits across diverse populations.
