Concept Medical Scores Fifth US FDA IDE Approval for MagicTouch AVF in Haemodialysis Access Management

Surat : Concept Medical, a leading innovator in medical device technology  having its manufacturing facility based in Surat, Gujarat, has secured a crucial milestone with the US Food and Drug Administration (FDA) granting an Investigational Device Exemption (IDE) for its MagicTouch AVF. This Sirolimus drug-coated balloon (DCB) catheter is poised to revolutionize the treatment of stenotic lesions in Arteriovenous Fistula (AVF) for patients undergoing Haemodialysis management of Chronic Renal Failure.

This marks Concept Medical’s fifth consecutive US FDA IDE approval for its versatile MagicTouch product line, each addressing distinct clinical needs. The latest approval empowers the company to conduct pivotal clinical studies, gathering vital safety and efficacy data for the MagicTouch Sirolimus Coated Balloon in AV fistula applications. This data will be instrumental in securing a future Premarket Approval (PMA) application within the US market.

Chronic renal failure patients on Haemodialysis frequently encounter blockages within the arteriovenous fistula, a vital access point for the life-sustaining treatment. MagicTouch AVF presents a novel approach for managing these stenotic lesions, potentially enhancing patient outcomes in Haemodialysis. This approval reinforces Concept Medical’s unwavering commitment to developing cutting-edge solutions that improve patient care and quality of life by addressing stenotic arterial lesions.

Dr. Manish Doshi, Founder of Concept Medical, expressed his elation: “This approval signifies not only our unwavering pursuit of innovation but also a pivotal moment in transforming the treatment landscape for Haemodialysis patients. We are confident MagicTouch AVF will demonstrably improve patient care, and we eagerly anticipate the upcoming clinical trials.”

Concept Medical remains dedicated to pioneering solutions that address unmet patient needs. The company plans to initiate the AVF IDE clinical trial for MagicTouch SCB within the coming month and is actively enrolling participants for the ongoing US trials involving other MagicTouch product applications. With a steadfast dedication to fostering patient care through continuous innovation, Concept Medical remains committed to improving the lives of patients worldwide.