Norman Regional Announces Availability of Breakthrough New Treatment for Patients with Peripheral Artery Disease
Pantheris First-Ever Image-Guided Atherectomy Device Designed to Empower Physicians to Precisely Remove Plaque While Avoiding Disruption of Healthy Arteries
NORMAN, OK - Norman Regional’s HealthPlex is the first hospital in Oklahoma to offer a new treatment recently cleared by the U.S. Food and Drug Administration (FDA) to provide relief for patients suffering from the painful symptoms of peripheral artery disease, or PAD – a condition caused by a build-up of plaque that blocks blood flow in the arteries of legs or feet.
The device, Avinger’s Pantheris™ lumivascular atherectomy system, is an innovative image-guided therapy that, for the first time ever, allows physicians to see and remove plaque simultaneously during atherectomy – a minimally invasive procedure that involves cutting plaque away from the artery and clearing it out to restore blood flow.
Cardiologist Dr. Archana Gautam performed the state’s first procedure using this device on March 30, 2016 at Norman Regional’s HealthPlex.
Because the Pantheris device incorporates real-time optical coherence tomography (OCT) imaging on a therapeutic catheter – like having a small camera on the tip of the device – physicians are able to remove this plaque more precisely than ever before, with less risk of damage to the artery walls which can result in aggressive scarring that greatly increases the risk of restenosis, or re-narrowing of the artery. In the past, physicians have had to rely solely on X-ray as well as touch and feel to guide their tools while they try to treat complicated arterial disease.
For patients, this safe and more-precise treatment may potentially reduce the need for follow-up procedures and stents.
"Peripheral artery disease is a common, costly and deadly disease that greatly impacts quality of life, with patients experiencing cramping, numbness, discoloration and pain. When left untreated PAD can also led to amputation," said Dr. Gautam. "We are excited about the availability of the Pantheris technology, which is a significant step forward for the treatment of the condition, enabling a more precise removal of the plaque that is the cause of the symptoms of PAD."
Clinical results confirm that the technology is safe and effective: a 130-patient study showed a target lesion revascularization rate of just 8 percent, and not a single event of vessel perforation, clinically significant dissection or late aneurysm resulted from Pantheris. In addition, this radiation-free technology may help minimize radiation exposure to clinicians and patients by decreasing use of fluoroscopy.
Peripheral artery disease affects nearly 20 million adults in the U.S.(1) and over 200 million people globally.(2) PAD is caused by a build-up of plaque in the arteries that blocks blood flow to the legs and feet. Often dismissed as normal signs of aging, symptoms of PAD include painful cramping, numbness or discoloration in the legs or feet. PAD can become so severe and difficult to address with traditional treatments that patients and physicians often resort to undergoing invasive bypass surgeries, which can result in even higher health risks and lengthy, painful recoveries. In severe cases, patients often face amputation, the worst-case scenario associated with PAD.
Atherectomy is a minimally invasive treatment for PAD in which a catheter-based device is used to remove plaque from a blood vessel. Lumivascular technology utilized in the Pantheris system allows physicians, for the first time ever, to see from inside the artery during a directional atherectomy procedure by using an imaging modality called optical coherence tomography, or OCT. In the past, physicians have had to rely solely on X-ray as well as touch and feel to guide their tools while they try to treat complicated arterial disease. With the lumivascular approach, physicians can more accurately navigate their devices and treat PAD lesions, thanks to the OCT images they see from inside the artery.
About Norman Regional Health System
Norman Regional Health System is a multi-campus system that serves the healthcare needs of south central Oklahoma. It is currently comprised of an acute-care facility, Norman Regional, on Porter Avenue, and the Norman Regional HealthPlex, located on Interstate 35 and Tecumseh Road in Norman, OK. Norman Regional Hospital is licensed for 324 beds and offers a full range of services including emergency care, oncology, an intensive care unit, surgery and more. The Norman Regional HealthPlex campus is licensed for 136 beds. It features the services of cardiovascular, spine and orthopedics, women’s and children’s and more. The Norman Regional HealthPlex is also the home of the Chest Pain Center and the HealthPlex Heart Hospital. In 2016, the Health System is schedule to open a new facility in Moore, Oklahoma. Norman Regional Health System has grown to employ more than 2,700 people and have 356 physicians credentialed on the Medical Staff.
- The Sage Group releases New Estimates for the United States Prevalence of Peripheral Artery Disease (PAD) and Critical Limb Ischemia (CLI). The Sage Group. September 30, 2010. http://thesagegroup.us/pages/news/pad-cli-new-numbers-10.php.
- Fowkes FG, Rudan D, Rudan I, et al. “Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: a systematic review and analysis.” Lancet 2013; 382:1329.