Concept Medical has announced the commencement of its investigational device exemption (IDE) clinical study, MAGICAL-ISR using the MagicTouch sirolimus drug-coated balloon (DCB), for the management of in-stent restenosis (ISR) in coronary artery disease.
MagicTouch had earlier been granted a breakthrough device designation in ISR and later IDE approval by the US Food Drug Administration (FDA). The first patient enrolment was done at the AtlantiCare Institute, Atlantic City (USA), by Said Ashraf and team.
The MAGICAL-ISR study aims to assess the safety and efficacy of this sirolimus DCB in treating ISR, focusing on the proportion of patients avoiding target lesion failure (TLF) within one-year post-procedure. The study was initiated under the guidance of Martin Leon (Columbia University, New York, USA), Azeem Latib (Montefiore Health Systems, New York, USA) and Ajay J Kirtane (Columbia University Irving Medical Center/NewYork-Presbyterian Hospital, New York, USA).
“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 United States,” said Leon, who is the study chair and founder of the Cardiovascular Research Foundation (CRF).
Manish Doshi, founder and managing director of Concept Medical 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.”
