On January 21, 2014, Jose L. Trani, MD, and Francis Caputo, MD, became the first in North America to treat abdominal aortic aneurysms (AAA) with a new-generation sealing system when they implanted the first, investigational Nellix® EVAS device from Endologix as part of a global, multi-center clinical trial. The procedure was performed on a 58 year old South Jersey man who was discharged less than 24 hours after his procedure and is doing exceptional.
Jeffrey P. Carpenter, MD, Chairman and Chief of Surgery for Cooper University Health Care in New Jersey, is the study’s global principal investigator. “The unique ability of Nellix to seal the entire aneurysm sac is breakthrough technology and is the first meaningful advancement in AAA repair since endovascular grafts were introduced in the late 1990s,” said Dr. Carpenter. “This is ground-breaking treatment, and we believe Nellix has the potential to dramatically change the way AAAs are treated universally.”
An aortic aneurysm is a bulge in a section of the aorta, the body’s main artery. The aorta carries oxygen-rich blood from the heart to the rest of the body. Because the section with the aneurysm is overstretched and weak, it can burst. If the aorta bursts, it can cause serious bleeding that can quickly lead to death. Each year, physicians diagnose approximately 200,000 people in the United States with AAA. Of those 200,000, nearly 15,000 may have AAA threatening enough to cause death from its rupture if not treated.
Risk factors for developing abdominal aortic aneurysm are those who have been diagnosed with atherosclerosis or hardening of the arteries, high blood pressure, smoking and those 60 years of age and older. AAA is more common in men than in women and having an immediate relative, such as a mother or brother, who has had AAA also increases the risk.
According to Dr. Carpenter, AAAs are typically treated in one of two ways. In a traditional (open) repair, a large incision is made in the abdomen and the abnormal vessel is replaced with a graft made of man-made material. This method involves major surgery and longer recovery times.
The other approach is called endovascular stent grafting. This procedure can be done minimally invasive, and results in shorter recovery times. However, endovascular stent grafting may develop leaks over time and requires frequent monitoring and possible repair over time.
The Nellix EVAS system is a new generation of AAA therapy because it is designed to seal the entire aneurysm with a biocompatible polymer. “Nellix is the first and only of its kind,” said Dr. Carpenter. “It was developed to simplify procedures, reduce re-interventions and expand the treatable patient population.”