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Concept Medical Receives US FDA IDE Approval for MagicTouch AVF in Haemodialysis Treatment

Concept Medical, a leading innovator in medical device technology, has announced the approval of an Investigational Device Exemption (IDE) for its US FDA Breakthrough designated MagicTouch AVF. This breakthrough device is designed for the treatment of stenotic lesions of Arteriovenous Fistula (AVF) in the management of Chronic Renal Failure during haemodialysis.

The company has received four previous US FDA IDE approvals for its MagicTouch product portfolio, making this latest IDE approval the fifth in quick succession. This milestone allows Concept Medical to conduct pivotal clinical studies to gather safety and efficacy data for the MagicTouch Sirolimus Coated Balloon in A.V. fistula, supporting a future pre-market approval (PMA) application in the USA.

Haemodialysis procedures, crucial for managing chronic renal failure, often encounter blockages in the arteriovenous fistula used for the procedure. MagicTouch AVF offers a novel approach to managing stenotic lesions of arteriovenous fistula, potentially enhancing patient outcomes in haemodialysis, a life-sustaining treatment for individuals with renal failure. This approval underscores Concept Medical’s dedication to excellence and innovation in managing stenotic arterial lesions, ultimately improving patient care and quality of life.

Dr. Manish Doshi, Founder of Concept Medical, emphasized the significance of this approval, stating, "This approval not only reflects our unwavering commitment to innovation but also represents a pivotal moment in our quest to redefine the treatment landscape for haemodialysis patients. We are excited about the positive impact MagicTouch AVF will have on patient care and eagerly anticipate the upcoming clinical trials."

Concept Medical is dedicated to pioneering solutions that address the unmet needs of patients. The company is poised to initiate the AVF IDE clinical trial for MagicTouch SCB in the coming month and is on track to begin enrolment for other currently approved IDE trials of the MagicTouch product in the US. With a steadfast focus on advancing patient care through innovation, Concept Medical remains committed to improving the lives of patients worldwide.

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