Leg pain, difficulty walking, numbness or weakness in the legs, sores on toes, feet or legs that just won’t heal – people often attribute these symptoms to aging but they could be signs of a serious condition called peripheral artery disease (PAD).
An estimated 12 million people in the United States suffer from PAD, a circulatory problem in which plaque narrows arteries reducing blood flow to the legs, heart and brain. Left untreated, it could lead to amputation, heart attack and stroke.
The VISION clinical trial evaluates the Avinger Pantheris catheter for the treatment of PAD. The catheter allows vascular surgeons to see inside arteries as they cut away the plaque that narrows them. The first three procedures done in the U.S. using the Pantheris catheter were performed by John Pigott, MD, FACS, a vascular surgeon at Jobst Vascular Institute at ProMedica Toledo Hospital.
“The ability to visualize the artery in real time allows surgeons to target the plaque without damaging the artery, which can cause re-blockage,” said Dr. Pigott. “This will make procedures much more precise and improve patient outcomes.”
Current treatments to remove plaque involve inserting a balloon or stent to open narrow arteries or using X-ray images before surgery to determine what needs to be cut and what should be left alone. Both the traditional and clinical trial techniques are outpatient procedures done under local anesthesia while the patient is awake and no rehabilitation is required.
“This has the potential to revolutionize the treatment of vascular disease,” said Dr. Pigott.
The Avinger Pantheris catheter is an investigational device that is not approved for sale in the United States.