Concept Medical, a renowned leader in innovative medical device technology, has achieved a significant milestone with the approval of its Investigational Device Exemption (IDE) for the MagicTouch AVF by the US Food and Drug Administration (FDA). This breakthrough designation marks the 5th IDE approval garnered by Concept Medical, further solidifying its position as a pioneer in advancing medical device solutions.

The MagicTouch AVF, designed specifically for the treatment of stenotic lesions of Arteriovenous Fistula (AVF) in the management of Chronic Renal Failure during haemodialysis, represents a groundbreaking approach to addressing a critical need in patient care. The approval paves the way for pivotal clinical studies aimed at gathering safety and efficacy data to support future pre-market approval (PMA) applications in the USA.

Dr. Manish Doshi, Founder of Concept Medical, expressed enthusiasm about the approval, emphasizing its significance in redefining the treatment landscape for haemodialysis patients. “This approval is not just a testament to our relentless pursuit of innovation but also marks a pivotal moment in our journey to redefine the treatment landscape for haemodialysis patients,” stated Dr. Doshi.

The MagicTouch AVF offers a novel solution for managing stenotic lesions of arteriovenous fistula, addressing a common challenge faced by chronic renal failure patients undergoing haemodialysis. By providing a unique approach to enhancing patient outcomes, Concept Medical continues to demonstrate its commitment to excellence and innovation in improving patient care and quality of life.

Concept Medical, headquartered in Tampa, Florida, with a global presence, specializes in developing innovative drug delivery technology for vascular and non-vascular diseases. With a focus on advancing patient care through innovation, the company remains dedicated to improving the lives of patients worldwide.

As Concept Medical prepares to initiate the AVF IDE clinical trial for MagicTouch SCB in the coming months, the company remains steadfast in its commitment to pioneering solutions that address the unmet needs of patients. With ongoing efforts to advance patient care through innovation, Concept Medical is poised to make a significant impact on the treatment landscape for chronic renal failure patients undergoing haemodialysis.

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