Concept Medical today announced it received FDA investigational device exemption for its MagicTouch AVF Sirolimus drug-coated balloon (DCB) catheter.
The IDE allows the Tampa, Florida-based company to start a clinical study to treat stenotic lesions of arteriovenous fistula (AVF) in the hemodialysis management of chronic renal failure.
“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,” Founder Manish Doshi said in a news release.
Concept Medical’s clinical study will gather safety and efficacy data for the MagicTouch AVF in arteriovenous fistula to support a future premarket approval application in the U.S.
More about the device
The drug-coated balloon has Nanolute technology that improves the lipophilicity and bioavailability of Sirolimus. The drug is coated on the unfolded balloon, then navigated to the needed location in the body where it inflates with 100% surface area coated. MagicTouch AVF can refold for a better crossing profile, according to the company.
Concept Medical designed the device to address repeated blockages of the AVF in patients with chronic renal failure who have to have multiple hemodialysis procedures.
