AV Medical Technologies has announced that it has received U.S. Food and Drug Administration (FDA) clearance for its Chameleon angioplasty balloon catheter.
According to AV Medical Technologies, the Chameleon’s PIP technology incorporates proprietary catheter construction that allows for targeted fluid delivery with an intuitive, easy to use design. AV Medical claims that PIP makes the Chameleon the first and only angioplasty balloon catheter to allow for simultaneous balloon inflation and in and intravascular injection of fluids while maintaining guidewire access.
Anthony Verstandig, who led the first clinical trial and is Director of Interventional Radiology at Shaare Zedek Medical Center in Jerusalem, claims “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, Limor Sandach states, “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.”