Concept Medical Launches Groundbreaking Study for ISR Treatment with MagicTouch DCB

Surat : Concept Medical, a trailblazer in innovative drug delivery technologies with manufacturing facilities in Surat, has announced the commencement of a pioneering clinical study named “MAGICAL-ISR.” This study utilizes the revolutionary MagicTouch Sirolimus drug coated balloon (DCB) for managing in-stent restenosis (ISR) in coronary artery disease patients. The initiation of this study marks a significant milestone in the field of cardiovascular intervention.

Concept Medical, a frontrunner in cutting-edge drug delivery solutions, has launched a groundbreaking clinical study titled “MAGICAL-ISR,” aimed at revolutionizing the treatment of in-stent restenosis (ISR) in patients with coronary artery disease. The study employs the innovative MagicTouch Sirolimus drug coated balloon (DCB), representing a paradigm shift in coronary intervention techniques.

The MAGICAL-ISR study, initiated by Concept Medical, aims to evaluate the safety and efficacy of the MagicTouch Sirolimus DCB in treating ISR. The primary endpoint of the study focuses on assessing the proportion of patients who avoid Target Lesion Failure (TLF) within one year post-procedure. This study holds immense promise for improving patient outcomes and addressing the clinical challenges associated with ISR management.

The first patient enrollment for the MAGICAL-ISR study took place at the AtlantiCare Institute in Atlantic City, NJ, under the guidance of Dr. Said Ashraf (MD – Interventional Cardiology) and his esteemed team. The initiation of patient enrollment marks a significant milestone in the journey towards advancing cardiovascular care through innovative medical technologies.

MagicTouch Sirolimus DCB has garnered significant attention in the medical community, receiving a ‘Breakthrough Device’ designation from the US FDA and subsequent Investigational Device Exemption (IDE) approval. This recognition underscores the transformative potential of MagicTouch in addressing unmet clinical needs and improving patient outcomes.

Dr. Martin Leon, Study Chair and Founder of the Cardiovascular Research Foundation (CRF) in New York, expressed his enthusiasm for the MAGICAL-ISR study, highlighting its potential to usher in a new era of safe and efficacious drug-eluting balloon therapy for coronary artery disease patients. Dr. Leon’s endorsement underscores the significance of this clinical trial in shaping the future of cardiovascular intervention.

Dr. Manish Doshi, Founder & Managing Director of Concept Medical, emphasized the company’s unwavering commitment to innovation and patient safety. The entry of MagicTouch technology into the US market through the MAGICAL-ISR study signifies a pivotal step towards addressing critical unmet needs in ISR treatment and improving patient care on a global scale.

Concept Medical’s pioneering efforts with MagicTouch have set a new standard in coronary intervention, earning global recognition and acclaim. The MAGICAL-ISR study, alongside other ongoing IDE clinical trials, underscores Concept Medical’s dedication to advancing clinical excellence and fostering innovation in cardiovascular care.