Concept Medical's MagicTouch AVF Granted US FDA IDE Approval for Fifth Clinical Study in MagicTouch Portfolio

2 April 2024

Concept Medical has recently received FDA IDE Approval for its Sirolimus drug-coated balloon (DCB) catheter, known as the MagicTouch AVF. This approval allows the company to embark on a clinical study aimed at treating stenotic lesions of Arteriovenous Fistula (AVF) in managing Chronic Renal Failure through hemodialysis. Notably, this marks the fifth consecutive IDE approval for Concept Medical's MagicTouch product portfolio in the United States.

With this latest regulatory milestone, Concept Medical is empowered to conduct pivotal clinical trials to gather essential safety and efficacy data for the MagicTouch Sirolimus Coated Balloon in treating AVF stenotic lesions. These trials will provide critical support for future pre-market approval (PMA) applications in the US market.

The significance of the MagicTouch AVF lies in its potential to address the challenges associated with stenotic lesions of arteriovenous fistula, a common occurrence in patients undergoing multiple hemodialysis procedures for chronic renal failure management. By offering a novel approach to managing these lesions, the MagicTouch AVF holds promise in improving patient outcomes in hemodialysis, a vital life-sustaining treatment for individuals with renal failure.

Concept Medical's achievement of FDA IDE Approval underscores its unwavering dedication to excellence and innovation in managing stenotic arterial lesions. This commitment reflects the company's broader mission of enhancing patient care and quality of life through cutting-edge medical technologies.

Looking ahead, Concept Medical is poised to initiate the AVF IDE clinical trial for MagicTouch SCB promptly. Additionally, the company remains on track to commence enrollment for other approved IDE trials of the MagicTouch product in the US market. With a steadfast focus on advancing patient care through innovation, Concept Medical continues to demonstrate its commitment to improving the lives of patients worldwide.