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Concept Medical's MagicTouch AVF Granted FDA IDE Approval for Clinical Study

Concept Medical's MagicTouch AVF Granted FDA IDE Approval for Clinical Study

Concept Medical, a company in innovative medical device technology, has received Investigational Device Exemption (IDE) approval from the US Food and Drug Administration (FDA) for its MagicTouch AVF, a Sirolimus drug-coated balloon (DCB) catheter. 

This approval marks a significant milestone in the company's efforts to initiate a clinical study for the treatment of stenotic lesions of Arteriovenous Fistula (AVF) in the Haemodialysis management of Chronic Renal Failure.

The MagicTouch AVF is designed to address the challenge of repeated blockages in arteriovenous fistulas, a common occurrence in patients undergoing haemodialysis for chronic renal failure. By offering a novel approach to managing stenotic lesions, Concept Medical aims to improve patient outcomes and enhance the effectiveness of haemodialysis treatment.

Dr. Manish Doshi, Founder of Concept Medical, expressed enthusiasm about the FDA IDE approval, stating, "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."

The approval allows Concept Medical to conduct pivotal clinical studies to gather safety and efficacy data for the MagicTouch Sirolimus Coated Balloon in AVF, supporting a future pre-market approval (PMA) application in the USA. This achievement underscores Concept Medical's commitment to excellence and innovation in addressing the unmet needs of patients undergoing haemodialysis.

Concept Medical has also received four other US FDA IDE approvals for its MagicTouch product portfolio for different indications, highlighting the company's dedication to advancing patient care through cutting-edge medical technology. With a focus on improving patients' lives worldwide, Concept Medical is poised to initiate the AVF IDE clinical trial for MagicTouch SCB in the coming months, along with enrolling participants for other approved IDE trials of the MagicTouch product in the US.

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More news about: global pharma | Published by Abha | April - 02 - 2024

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