Concept Medical, a leader in innovative drug delivery technologies, has announced the commencement of a groundbreaking clinical study named "MAGICAL-ISR." This study utilizes MagicTouch – a Sirolimus Drug Coated Balloon (DCB) – to manage In-Stent Restenosis (ISR) in patients with Coronary Artery Disease (CAD).

MagicTouch, previously granted a 'Breakthrough Device' designation by the US FDA, represents a significant advancement in coronary intervention. Unlike traditional stents, MagicTouch offers controlled and sustained release of Sirolimus without the need for permanent scaffolding.

The MAGICAL-ISR IDE study, initiated at the AtlantiCare Institute in Atlantic City, NJ, under the guidance of esteemed physicians Dr. Martin Leon, Dr. Azeem Latib, and Dr. Ajay J. Kirtane, aims to assess the safety and efficacy of MagicTouch in treating ISR. The primary focus is on evaluating the proportion of patients avoiding Target Lesion Failure (TLF) within one year post-procedure.

Dr. Martin Leon, Study Chair & Founder of Cardiovascular Research Foundation (CRF) in New York, expressed excitement about the study's launch, stating, "This momentous clinical trial will herald an era of safe and efficacious DEB therapy to complement and improve the management of complex obstructive coronary disease for our patients in the United States."

Dr. Manish Doshi, Founder & Managing Director of Concept Medical, emphasized the company's commitment to innovation and patient safety, stating, "Our entry into the US market through this study represents a critical step towards addressing the unmet needs in ISR treatment. We anticipate this study will significantly impact how ISR is treated worldwide."

Concept Medical's MagicTouch technology, recognized with the FDA's Breakthrough Designation status, has set a benchmark as the world's first sirolimus drug-coated balloon. The MAGICAL-ISR study, alongside other ongoing IDE clinical studies, underscores the company's dedication to clinical excellence and innovation in the field of coronary intervention.