PRNewswire
Tampa (Florida) [US], April 2: Concept Medical has been granted ‘IDE Approval’ from the U.S. Food and Drug Administration (FDA) for MagicTouch AVF, its Sirolimus drug-coated balloon (DCB) catheter, to initiate a clinical study for the treatment of stenotic lesions of Arteriovenous Fistula in the Haemodialysis management of Chronic Renal Failure.
Concept Medical a leader in innovative medical device technology, has announced approval of an Investigational Device Exemption (IDE) for its US FDA Breakthrough designated MagicTouch AVF for the treatment of stenotic lesions of Arteriovenous Fistula (AVF) in the Haemodialysis management of Chronic Renal Failure.
The Company has been granted four other US FDA IDE approvals for its MagicTouch product portfolio for different indications. The latest IDE approval for the AVF indication is their 5th in quick succession.
This US FDA IDE approval allows Concept Medical to conduct pivotal clinical studies to gather safety and efficacy data for the MagicTouch Sirolimus Coated Balloon in A.V. fistula & support a future pre-market approval (PMA) application in the USA.
The multiple haemodialysis procedures necessary for the management of chronic renal failure patients often result in repeated blockages of the arteriovenous fistula used for the procedure. MagicTouch AVF is proposed for managing such stenotic lesions of arteriovenous fistula, offering a novel approach that could potentially enhance patient outcomes in haemodialysis, a life-sustaining treatment for those with renal failure. This latest approval underscores Concept Medical’s commitment to excellence and innovation in managing stenotic arterial lesions that improve patient care and quality of life.
Dr Manish Doshi, Founder of Concept Medical, stated that, “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. We look forward to MagicTouch AVF’s positive impact on patient care and are excited about the upcoming clinical trials.”
Concept Medical is committed to pioneering solutions that address the unmet needs of patients. The Company eagerly anticipates initiating the AVF IDE clinical trial for MagicTouch SCB in the coming month and are on track to begin enrolment for the currently approved other IDE trials of the MagicTouch product in the US. With a focus on advancing patient care through innovation, Concept Medical remains dedicated to improving patients’ lives worldwide.
About Concept Medical.:
Concept Medical is headquartered in Tampa, Florida, and has a global presence. CM specializes in developing innovative drug delivery technology for vascular and non-vascular diseases, utilizing a unique combination of technology & products with proprietary coating technology that delivers pharmaceutical agents across luminal surfaces of blood vessels.
For more information, please visit [www.conceptmedical.com]
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