Concept Medical Enrolls First Patient in “MAGICAL-ISR” IDE Study in US
Concept Medical has initiated the “MAGICAL-ISR” IDE clinical study in the US, utilizing the MagicTouch Sirolimus drug-coated balloon (DCB) for in-stent restenosis (ISR) management.
Concept Medical – FDA Approval
The study, granted ‘Breakthrough Device’ designation and FDA Investigational Device Exemption (IDE) approval, aims to evaluate the safety and efficacy of MagicTouch in treating ISR. Led by renowned physicians, the study focuses on patients avoiding Target Lesion Failure (TLF) within one year post-procedure.
MagicTouch offers controlled Sirolimus release without permanent scaffold implantation, marking a significant advancement in coronary intervention. This development reflects Concept Medical’s commitment to innovation and patient care.
Dr Manish Doshi, Founder & Managing Director of Concept Medical says, “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.”
Read More Business News
Table of Contents
