AV Medical Technologies Wins 510(k) Clearance for Balloon Catheter

The FDA has granted 510(k) clearance to Israel-based AV Medical Technologies for its Chameleon angioplasty balloon catheter.

The device features proximal injection port technology and is the first and only angioplasty balloon catheter enabling simultaneous balloon inflation and intravascular injection of fluids while maintaining guidewire access, the company says.

“The proximal injection of fluids provides important clinical advantages over standard balloon catheters,” says Dr. Anthony Verstandig, who led the first clinical trial of the catheter.

AV Medical Technologies is a developer of solutions to improve visualization during catheter-based interventions, while minimizing procedural steps. — Michael Cipriano