Israel based AV Medical said today it won FDA 510(k) clearance for its Chameleon angioplasty balloon catheter.
The company’s Chameleon catheter comes equipped with proximal injection port technology which the company claims make it the 1st and only angioplasty balloon catheter that allows for simultaneous balloon inflation and injection of intravascular fluids during guidewire access.
“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 2 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,” CEO Limor Sandach said in a press release.
The PIP technology allows for the injecting of contrast and other fluids while the guidewire is intact, the company said.
“I see the Chameleon as a significant advancement in balloon catheter technology. 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,” clinical trial leader Dr. Anthony Verstandig of Jerusalem’s Shaare Zedek Medical Center said in prepared remarks.
AV Medical, founded in 2012, seeks to “improve visualization during catheter-based intervention while minimizing procedural steps,” according to the company.