Concept Medical enrolls first patient in “Magical-ISR” IDE study in the US, as reported by ET HealthWorld

Concept Medical, a leader in innovative drug delivery technologies, has initiated a groundbreaking IDE clinical study called “MAGICAL-ISR” using MagicTouch – Sirolimus drug-coated balloon (DCB) for managing in-stent restenosis (ISR) in coronary artery disease. The study aims to assess the safety and efficacy of Sirolimus DCB in treating ISR, with a focus on the proportion of patients avoiding Target Lesion Failure (TLF) within one year post-procedure.

The first patient enrollment for the MAGICAL-ISR study took place at the AtlantiCare Institute in Atlantic City, NJ, led by Dr. Said Ashraf and his team. MagicTouch represents a significant advancement in coronary intervention, providing a controlled and sustained release of Sirolimus without the need for a permanent scaffold.

Dr. Martin Leon, Study Chair, and Founder of Cardiovascular Research Foundation (CRF) in New York, expressed enthusiasm for the study, highlighting the potential for safe and effective DEB therapy in managing complex coronary disease. Dr. Manish Doshi, Founder, and Managing Director of Concept Medical, emphasized the global acceptance of MagicTouch and its impact on addressing unmet needs in ISR treatment.

The FDA’s Breakthrough Designation status for MagicTouch underscores its significance in the field. Concept Medical’s dedication to innovation and patient safety is evident in the MAGICAL-ISR study and other ongoing IDE clinical studies. This study marks a critical step towards advancing ISR treatment and improving patient outcomes worldwide.