PORTLAND, Maine — Maine Medical Center Research Institute has been chosen as one of 30 sites worldwide, and the only one in Maine, to serve as a clinical trial site for a new investigational stent graft device designed to be used for the repair of infrarenal abdominal aortic aneurysms.
This trial — EVAS FORWARD, sponsored by Endologix, Inc. — will evaluate the safety and efficacy of the Nellix™ EndoVascular Aneurysm Sealing system. The device is not commercially available in the United States, and will only be available at selected clinical study sites for investigational purposes.
“The Nellix EVAS system is a new generation of abdominal aortic aneurysm therapy designed to seal the entire aneurysm,” said Dr. Christopher Healey, who is leading the trial at Maine Medical Center, according to a press release. “Nellix is the first and only EVAS product, and was developed to simplify procedures, reduce re-interventions and expand the treatable patient population. Clinical experience outside of the U.S. with the device has been very promising — showing initial safety and feasibility of the device. We look forward to being a part of this important clinical trial.”
The aorta is the body’s main artery, carrying blood from the heart to the rest of the body. AAA is an enlarged and weakened section, or “ballooning” of the aorta below the renal arteries that is prone to rupture and often times death. Infrarenal AAA occurs below the renal arteries, in blood vessels that lead to the kidneys. Fortunately, many patients benefit from minimally invasive (endovascular) repair of the aorta using special stents that create a new pathway for blood flow away from the aneurysm. With EVAS, once the stents are in place, special endobags surrounding the stents are filled with a polymer material to protect the aorta while excluding and sealing the aneurysm from blood flow.
Patients and referring physicians interested in learning more about the EVAS FORWARD IDE Trial may contact Christopher Healey, M.D., Principal Investigator at 207-774-6368, or Study Coordinator Sue Mortenson, R.N. at 207-661-7646.
Endologix Inc. develops and manufactures minimally invasive treatments for aortic disorders. Additional information about the Company can be found at www.endologix.com