Newswise — TOLEDO, Ohio, August 26, 2014 – 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 PantherisTM 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.
For more information about Jobst Vascular Institute, visit www.promedica.org/jobst.
About VISION and Avinger
VISION is a non-randomized, prospective, global, single arm clinical trial that is evaluating the safety and effectiveness of the PantherisTM catheter to perform directional atherectomy while using intravascular imaging to aid in the removal of plaque from diseased lower extremity arteries. As part of the trial, an independent group of physicians will review the angiography results to determine Pantheris’ efficacy and safety.
Avinger’s global product portfolio has helped physicians treat more than 20,000 patients suffering from PAD. Often dismissed as normal signs of aging, symptoms of PAD include painful cramping, numbness, or discoloration in the legs or feet. Hospitalization costs of PAD alone are estimated to exceed $21 billion annually, largely due to late detection and patients experiencing a decreased quality of life from invasive bypass surgery or amputation. To learn more about PAD, visit http://avinger.com/patients.
Founded in 2007 by renowned cardiologist and medical device entrepreneur Dr. John B. Simpson, Avinger seeks to radically change the treatment of vascular disease through the development of new technology and a new approach called lumivascular (lumi = light, vascular = artery). Lumivascular procedures use an interventional catheter system that incorporates light-based, radiation-free, intravascular imaging technology within the actual therapeutic device. This provides physicians with live, real-time, video-rate images of the inside of an artery during treatment, offering a variety of benefits for patients, physicians and hospitals. Ocelot, the first line of devices using lumivascular technology, has been commercially available since late 2012. This system is used to open totally occluded arteries in the legs. Avinger’s VISION trial is currently enrolling patients in the U.S. to evaluate the new lumivascular atherectomy catheter, PantherisTM.
Toledo, Ohio-based ProMedica is a mission-based, not-for-profit healthcare organization formed in 1986. ProMedica has more than 15,000 employees and nearly 1,900 physicians with more than 600 healthcare providers employed by ProMedica Physicians. Its 12 hospitals and more than 300 facilities offer comprehensive diagnostic, medical and surgical specialties in heart and vascular, oncology, orthopaedics, neurology, and women and pediatric services. ProMedica’s mission is to improve health and well-being, with a strong focus on wellness and clinical excellence, as well as innovative, community advocacy programs that address health-related issues such as hunger and obesity. For more information, please visit www.promedica.org.