Concept Medical, a pioneer in innovative drug delivery technologies, having its manufacturing facilities in Surat announced the commencement of its groundbreaking IDE clinical study, “MAGICAL-ISR” using MagicTouch – Sirolimus drug coated balloon (DCB), for the management of in-stent restenosis (ISR) in coronary artery disease. The first patient enrollment was done at the AtlantiCare Institute, Atlantic City, NJ, by Dr Said Ashraf (MD - Interventional Cardiology) and team.
MagicTouch in ISR indication, had earlier been granted a 'Breakthrough Device' designation and later the Investigational Device Exemption (IDE) approval by the US FDA. 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 esteemed physicians Dr Martin Leon, Dr Azeem Latib and Dr Ajay J. Kirtane.
MagicTouch represents a revolutionary advancement in coronary intervention, offering a controlled and sustained release of Sirolimus, akin to a drug-eluting stent but without the necessity of implanting permanent scaffold. "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." expressed Dr Martin Leon, Study Chair and Founder of Cardiovascular Research Foundation (CRF) , New York.
Dr Manish Doshi's remarks
Dr Manish Doshi, Founder & 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."
Concept Medical has set a benchmark with MagicTouch, the world's first sirolimus drug coated balloon, which has been widely adopted internationally and honoured with the FDA's Breakthrough Designation status. The MAGICAL-ISR study, alongside other ongoing IDE clinical studies, underscores the company's dedication to clinical excellence and innovation.
