Concept Medical has received FDA IDE Approval for a US Clinical Study of its MagicTouch AVF, its Sirolimus drug-coated balloon (DCB) catheter. Image courtesy: Concept Medical
April 2, 2024 — Medical device technology developer Concept Medical has announced it has been granted Investigational Device Exemption (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.
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, reported the company.
The FDA approval with an Investigational Device Exemption (IDE) permits a device to be shipped lawfully for the purpose of conducting investigations of the device without complying with other requirements of the Food, Drug, and Cosmetic Act (FD&C Act) that would apply to devices in commercial distribution.
According to the statement on the approval released by Concept Medical, this 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 United States. 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.
"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,” said Dr. Manish Doshi, Founder of Concept Medical, in a written statement. He added, “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.
Headquartered in Tampa, FL, the company reports that it 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.
More information: www.conceptmedical.com
Related coverage:
CONCEPT MEDICAL'S RECEIVES FDA APPROVAL FOR THE MAGICTOUCH-SIROLIMUS COATED BALLOON
June 13, 2024 
