Drug delivery technology provider Concept Medical has enrolled the first patient in investigational device exemption (IDE) MAGICAL-ISR study of its MagicTouch system.
MagicTouch is a sirolimus drug coated balloon (DCB) system designed to manage in-stent restenosis (ISR) in coronary artery disease.
The DCB has previously received both breakthrough device designation and IDE approval from the US Food and Drug Administration (FDA).
The enrolment of the first patient took place at the AtlantiCare Institute in Atlantic City, New Jersey.
MagicTouch is said to offer a controlled and sustained release of sirolimus during coronary intervention. It functions like a drug-eluting stent but without a permanent scaffold.
MAGICAL-ISR study is intended to evaluate the safety and effectiveness of this sirolimus DCB in treating ISR. It will focus specifically on patients who avoid target lesion failure (TLF) within one-year post-procedure.
The trial started under the guidance of Martin Leon, Azeem Latib, and Ajay Kirtane.
Study chair and New York-based Cardiovascular Research Foundation founder Martin Leon said: “We are thrilled to announce the first enrolment 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 US.”
The Florida-based Concept Medical claims that MagicTouch as the world’s first sirolimus drug-coated balloon. It has been used in Europe, Asia, Latin America, the Middle East, and all other regions internationally where the CE Mark is accepted.
Concept Medical founder and managing director Manish Doshi said: “The MagicTouch technology has been embraced globally, and its entry into the US market through this study, represents a critical step towards addressing the unmet needs in ISR treatment.
“Our commitment to innovation and patient safety is unwavering, and we anticipate this study will significantly impact how ISR is treated worldwide.”
