AV Medical Technologies Ltd. Receives FDA Clearance for its Chameleon™ Angioplasty Balloon Catheter

TEL AVIV, Israel.,  AV Medical Technologies Ltd. announced today that it has received U.S. Food and Drug Administration (FDA) clearance for the Chameleon™ angioplasty balloon catheter. With its Proximal Injection Port (PIP™) technology, Chameleon™ is the first and only angioplasty balloon catheter that allows for simultaneous balloon inflation and intravascular injection of fluids while maintaining guidewire access. PIP™ technology incorporates proprietary catheter construction that allows for targeted fluid delivery with an intuitive, easy to use design.

“I see the Chameleon™ as a significant advancement in balloon catheter technology,” said Dr. Anthony Verstandig, who led the first clinical trial and is Director of Interventional Radiology at Shaare Zedek Medical Center in Jerusalem. “The proximal injection of fluids provides important clinical advantages over standard balloon catheters. Injecting contrast without removing the guidewire, as well as the ability to opacify vessels both downstream and upstream against the flow of blood significantly reduces exchanges and results in a safer and more efficient procedure.”

AV Medical’s CEO, Mrs. Limor Sandach stated, “Our entire team is thrilled with this news. Chameleon™ represents the first product to include our proprietary Proximal Injection Port design. We look forward to bringing Chameleon™ to the dialysis access market in the United States. Over two million angioplasty balloon catheters are used annually to maintain dialysis access worldwide. This is an exciting advancement to catheter-based interventions and offers potential for development into additional products.”

Source: BusinessWire