TEL AVIV, Israel–(BUSINESS WIRE) AV Medical Technologies announced on 27 February 2017 that its Chameleon PTA balloon catheter has received FDA clearance for an expanded indication to include infusion of diagnostic or therapeutic fluids.
“The Chameleon balloon offers advantages for experienced operators as well as those training in dialysis access procedures,” commented John Ross of the Dialysis Access Institute in Orangeburg, USA. “We appreciate the efficiency that it provides to these cases as well as the peace of mind that comes with maintaining wire access throughout the cases.”
Based on AV Medical’s proprietary Supervision design, Chameleon allows operators to inject diagnostic or therapeutic fluids through the catheter at any time during the procedure, whether the balloon is inflated or deflated, all while maintaining wire position.
“This is an important milestone in the development of our Chameleon product,” said Limor Sandach, CEO of AV Medical. “The expanded indication reinforces Chameleon’s ability to combine multiple functions in a single device.”
The labeling for Chameleon now reads: The Chameleon PTA Balloon Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula. The Chameleon enables the infusion of diagnostic or therapeutic fluids. This catheter is not for use in coronary arteries or cerebral vasculature.