Concept Medical enrolls first patient in ‘Magical-ISR’ IDE study in US

The MAGICAL-ISR IDE study aims to assess the safety & efficacy of this Sirolimus DCB in treating ISR, focusing on the proportion of patients avoiding TLF within 1 year post-procedure

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New Delhi: Concept Medical has commenced its ground-breaking IDE clinical study, “MAGICAL-ISR” using MagicTouch – Sirolimus Drug Coated Balloon (DCB), for the management of In-Stent Restenosis (ISR) in coronary artery disease (CAD).
MagicTouch in ISR indication had earlier been granted a ‘Breakthrough Device’ designation and later the Investigational Device Exemption (IDE) approval by US FDA. The first patient enrolment was done at the AtlantiCare Institute, Atlantic City, NJ, by Dr Said Ashraf (MD – Interventional Cardiology) and team.
The MAGICAL-ISR IDE study aims to assess the safety and efficacy of this Sirolimus Drug Coated Balloon (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 & Founder of Cardiovascular Research Foundation (CRF), New York.
Dr Manish Doshi, Founder & Managing Director of Concept Medical added, “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.”