Sam Brusco, Associate Editor04.02.24
Concept Medical has received investigational device exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to begin a clinical study of its MagicTouch AVF Sirolimus drug-coated balloon (DCB) catheter to treat stenotic lesions of arteriovenous fistula (AVF) in hemodialysis management of chronic renal failure.
The company was previously granted four other FDA IDE approvals for the MagicTouch portfolio for other indications. The latest IDE approval allows the company to conduct pivotal studies to support MagicTouch’s premarket approval application in the U.S.
The multiple hemodialysis procedures needed to manage chronic renal failure often result in repeated blockage of the AVFs used for the procedure. MagicTouch AVF is a possible solution to manage such AVF stenotic lesions. The novel approach could boost outcomes in hemodialysis.
Dr Manish Doshi, founder of Concept Medical, said, "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 hemodialysis patients. We look forward to MagicTouch AVF's positive impact on patient care and are excited about the upcoming clinical trials."
The company expects to start the AVF IDE trial for MagicTouch SCB within the month. The company also said it’s on track to initiate enrollment for the other approved IDE trials of MagicTouch in the U.S.
The company was previously granted four other FDA IDE approvals for the MagicTouch portfolio for other indications. The latest IDE approval allows the company to conduct pivotal studies to support MagicTouch’s premarket approval application in the U.S.
The multiple hemodialysis procedures needed to manage chronic renal failure often result in repeated blockage of the AVFs used for the procedure. MagicTouch AVF is a possible solution to manage such AVF stenotic lesions. The novel approach could boost outcomes in hemodialysis.
Dr Manish Doshi, founder of Concept Medical, said, "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 hemodialysis patients. We look forward to MagicTouch AVF's positive impact on patient care and are excited about the upcoming clinical trials."
The company expects to start the AVF IDE trial for MagicTouch SCB within the month. The company also said it’s on track to initiate enrollment for the other approved IDE trials of MagicTouch in the U.S.