Concept Medical announced today that it commenced the FDA investigational device exemption (IDE) study of its MagicTouch system.
MagicTouch, a sirolimus drug-coated balloon (DCB), treats in-stent restenosis (ISR) in coronary artery disease (CAD). Dr. Said Ashraf enrolled the first patient in the MAGICAL-ISR study at the AtlantiCare Institute in Atlantic City, New Jersey.
The balloon offers a controlled and sustained release of sirolimus. It mirrors the capabilities of a drug-eluting stent but without the necessity of a permanently implanted scaffold. Concept Medical aims to assess the safety and efficacy of its DCB in the trial with a focus on patients avoiding target lesion failure (TLF) at one year post-procedure. The study began under the guidance of Dr. Martin Leon, Dr. Azeem Latib and Dr. Ajay J. Kirtane.
Concept Medical said that its MAGICAL-ISR study underscores its “dedication to clinical excellence and innovation.”
“We are thrilled to announce the first enrollment of the MAGICAL-ISR study featuring the MagicTouch sirolimus drug-eluting balloon technology. 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.” said Dr. Martin Leon, study chair and founder of Cardiovascular Research Foundation (CRF), New York.
