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FDA approved clinical trial can improve patient outcomes and decrease need to restent after AAA event
BRIGHTON, MA, May 15, 2014 – St. Elizabeth’s Medical Center, a part of the Steward Health Care System and teaching affiliate of Tufts University School of Medicine, is the first hospital in Massachusetts to implant the innovative EndoVascular Aneurysm Sealing (EVAS) from Nellix™ as part of the EVAS FORWARD investigational trial. EVAS is the next generation abdominal aortic aneurysm (AAA) therapy intended to treat more anatomies than currently approved endovascular stent graft devices, and is the only technology whose operating principle is centered around sealing the aneurysm sac. The device is not commercially available in the United States, and will only be available at a few selected clinical study sites throughout the U.S., for investigational use.
AAA is when the large blood vessel (aorta) that supplies blood to the abdomen, pelvis and legs becomes abnormally large or balloons outward. An abdominal aortic aneurysm can develop in anyone, but is most often seen in males over age 60 who have one or more risk factors, including emphysema, high blood pressure and/or cholesterol, obesity, and smoking. The larger the aneurysm, the more likely it is to rupture and break open. The outcome is usually good if an experienced surgeon repairs the aneurysm before it ruptures. When an abdominal aortic aneurysm ruptures, it is a true medical emergency. Less than 80 percent of patients survive a ruptured abdominal aneurysm.
“AAA is life-threatening. With appropriate intervention, either open abdominal aortic aneurysm repair or minimally invasive stent graft repair, and subsequent lifestyle adjustments, prognosis is good,” said Nikhil Kansal, MD, FACS, chief of the Center for Vascular and Endovascular Surgery at St. Elizabeth’s Medical Center. “As a minimally invasive surgeon with expertise in current stent technology, I see many patients that need to be re-treated in the years following the initial intervention. With the advanced technology of EVAS, our goal is to minimize the need for re-interventions and less post-procedure patient monitoring. This benefits the patient by decreasing the need for future hospitalizations, and may also diminish the need for multiple follow-up visits with the vascular surgeon.”
Patients who have suffered a previous AAA, or who have been referred to a specialist for a suspected AAA, may be a candidate for this new stent. For more information, contact the Center for Vascular and Endovascular Surgery at St. Elizabeth’s at 617-779-6524.
About St. Elizabeth’s Medical Center
St. Elizabeth’s Medical Center is a major academic medical center affiliated with Tufts University School of Medicine. Areas of medical excellence include vascular and endovascular surgery, cardiology, neurosciences, general and robotic surgery, bariatric surgery, women’s health, high-risk obstetrics, bone and joint health, hematology/oncology, pulmonary medicine and emergency medicine. St. Elizabeth’s is a member of Steward Health Care, which is the second largest health care system in New England. Visit St. Elizabeth’s online at Steward.org/St-Elizabeths.
About Endologix, Inc.
Endologix Inc. develops and manufactures minimally invasive treatments for aortic disorders. Additional information about the Company can be found at www.endologix.com.