MAGICAL-ISR IDE Study of Concept Medical’s MagicTouch Sirolimus DCB Begins Enrollment

April 19, 2024—Concept Medical announced the commencement of the MAGICAL-ISR investigational device exemption (IDE) clinical study. The first patient in the study was enrolled by interventional cardiologist Said Ashraf, MD, at the AtlantiCare Institute in Atlantic City, New Jersey.

MAGICAL-ISR is assessing the safety and efficacy of the company’s MagicTouch sirolimus drug-coated balloon (DCB) for the management of in-stent restenosis (ISR) in coronary artery disease.

Concept Medical stated that the MagicTouch device is designed to provide a controlled and sustained release of sirolimus without the need for implanting a permanent scaffold. MagicTouch for the ISR indication was granted the Breakthrough Device designation from the FDA and subsequently received the FDA IDE approval.

According to the company, the study will focus on the rate of freedom from target lesion failure at 1-year postprocedure.

The MAGICAL-ISR study was initiated under the guidance of study chair Martin Leon, MD; Azeem Latib, MD; and Ajay J. Kirtane, MD.

“We are thrilled to announce the first enrollment of the MAGICAL-ISR study featuring the MagicTouch sirolimus drug-eluting balloon (DEB) technology,” commented Dr. Leon in Concept Medical’s press release. “This momentous clinical trial will herald an era of safe and efficacious DEB therapy under a variety of clinical and anatomic circumstances to complement and improve the management of complex obstructive coronary disease for our patients in the United States.” Dr. Leon is Founder of the Cardiovascular Research Foundation in New York, New York.

The MagicTouch sirolimus DEB has received CE Mark approval and is available in Europe and other international markets where the CE Mark is recognized, stated Concept Medical.