Avinger Enrolls First PAD Patient in VISION Global Clinical Trial
VISION Trial Evaluates First Ever Imaging Atherectomy Catheter to Treat Patients Suffering from Peripheral Artery Disease
TOLEDO, Ohio & REDWOOD CITY, Calif.--(BUSINESS WIRE)--Avinger Inc., pioneer of the lumivascular approach for treating vascular disease announced today that Dr. John Pigott of Jobst Vascular Institute, Toledo, OH, enrolled the first patient in VISION. VISION is a global IDE clinical trial, approved by the FDA to evaluate Avinger’s PantherisTM catheter for the treatment of Peripheral Artery Disease (PAD). It is estimated that PAD affects 12 million people in the US alone.
“We are convinced that Avinger’s Pantheris catheter will be a major step forward for our patients and for the entire medical community as the increased precision allowed by direct visualization is immediate and significant”
The PantherisTM system combines directional atherectomy capabilities with real-time intravascular visualization to remove plaque from blocked arteries. The minimally invasive catheter is designed to remove plaque, while avoiding the disruption of normal arterial wall structures. Despite other attempts in the industry, this has never been accomplished until now.
“While today is a big day for Avinger, it’s an even bigger day for physicians and hospitals looking for better ways to treat patients suffering from vascular disease. Today we are one step closer,” said Dr. John B. Simpson PhD MD, Avinger’s founder and CEO. “We designed Pantheris to help physicians better understand what is going on inside the artery as they are treating it. There isn’t a physician on the planet that doesn’t want more information about their patients’ disease state with the ability to act on it in real time.”
“For the first time ever, I am able to visualize the inside of the artery and selectively remove plaque without disrupting the healthy portion of the vessel. This has the potential to revolutionize the treatment of vascular disease,” said Dr. John Pigott.
“We are convinced that Avinger’s Pantheris catheter will be a major step forward for our patients and for the entire medical community as the increased precision allowed by direct visualization is immediate and significant,” said VISION Co-Principle Investigators Drs. William Crowder and J. Gray Bennett of St. Dominic Hospital, Jackson MS.
More about VISION
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.