February 26, 2017
Indication Expanded for AV Medical's Chameleon Balloon Catheter to Include Infusion of Diagnostic or Therapeutic Fluids
February 27, 2017—AV Medical Technologies, Ltd. announced that the company's Chameleon percutaneous transluminal angioplasty (PTA) balloon catheter has received clearance from the US Food and Drug Administration (FDA) for an expanded indication to include infusion of diagnostic or therapeutic fluids.
Based on AV Medical’s Supervision design, the Chameleon device allows for the injection of diagnostic or therapeutic fluids through the catheter at any time during the PTA procedure, whether the balloon is inflated or deflated, all while maintaining wire position.
According to the company, the FDA-cleared 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."
In the company's press release, John Ross, MD, of the Dialysis Access Institute in Orangeburg, South Carolina, commented, “The Chameleon balloon offers advantages for experienced operators as well as those training in dialysis access procedures. 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.”