AV Medical Technologies said today it won expanded FDA 510(k) clearance for its Chameleon PTA balloon catheter designed for the infusion of diagnostic or therapeutic fluids.
The Chameleon is designed to allow operators to inject diagnostic or therapeutic fluids through the catheter during procedures, whether the balloon is inflated or deflated and while maintaining wire position, the Israel-based company said.
“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,” Dr. John Ross of Orangeburg, S.C.’s Dialysis Access Institute said in a prepared statement.
The device is now cleared with indications for use in percutaneous transluminal angioplasty of the femoral, iliac and renal arteries, as well as for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula.
“This is an important milestone in the development of our Chameleon product. The expanded indication reinforces Chameleon’s ability to combine multiple functions in a single device,” CEO Limor Sandach said in a press release.