Georgetown Endovascular Specialist Performs First US Procedure with Aptus Endovascular AAA Repair System
Washington, DC - July 25, 2006 - David H. Deaton, MD, Chief of Endovascular Surgery at Georgetown University Hospital, performed the first procedure in the United States to utilize a novel and promising new endovascular graft system for the repair of an abdominal aortic aneurysm (AAA) on July 19, 2006. The patient, a 69-year-old male, enrolled as the first subject of an FDA approved clinical trial (the STAPLE-1 trial) designed to demonstrate the safety and feasibility of this new minimally invasive type of aneurysm repair, one that staples the endograft to the wall of the aorta, unlike current methods.
The patient who was treated lost both of his parents to AAA, a leading cause of sudden death. As a result of his family history he was keenly aware of the danger represented by AAA and was quick to seek vascular consultation at Georgetown University Hospital when his primary care physician detected his aneurysm after an ultrasound test.
This individual is the first of up to 25 potential patients slated for enrollment in the initial phase of this clinical trial, being conducted at five medical institutions in the United States.
Endovascular graft repair of aortic aneurysms has been approved in the United States since 1999. While widely accepted as a less invasive and safer procedure, the long term durability of current endografts has been a subject of great debate. Shifting, or migration, of the endograft has been responsible for late failure in some cases and has diminished the widespread applicability of this otherwise promising technique. Additionally the size of the device was often too large for the blood vessels that were to be used, resulting in denial of the patient for the minimally invasive repair.
The current endograft system, manufactured by Aptus Endosystems, Inc., is the first endovascular device to be attached to the aorta with individual staples that reproduce the suture fixation used in open surgical repair of AAA. The capability to deliver the staples separately, and where the surgeon determines necessary, makes it possible to provide a much smaller delivery system for the endograft. It also secures the endograft in place in a manner essentially identical to the grafts used in open surgical repair that have proven long term results. "The innovations of the Aptus aneurysm repair system represent a potential revolution in the applicability and durability of endovascular aneurysm repair. This is the first endovascular technology that allows us to repair the aorta using the principles which are the foundation of the very successful open surgical repair that has been the standard of care over the last 50 years", comments Dr. Deaton.
Georgetown University Hospital, and the team of vascular surgeons in the Division of Vascular Surgery, was chosen as the site for the initial procedure to be performed in the United States as a result of their involvement in the development of the device in cases done outside the U.S. and during the pre-clinical phase of the system's development.
Dr. David Deaton, of Georgetown, and Dr. Takao Ohki, of Montefiore Medical Center in New York, were part of a team of specialists who worked over the last two years on the device's design, and performed the first human implants of the device last summer in Venezuela. Both patients treated at that time had successful outcomes and continue to do well.
AAA is 80-90% fatal if left untreated and is the 3rd leading cause of sudden death in the United States, responsible for 30,000 deaths each year, according to The Society for Vascular Surgery.
"The problem with AAA is that it doesn't cause any symptoms until they rupture, which results in death in most patients. Awareness and screening for abdominal aortic aneurysms is vital if they are to be detected and treated successfully." said Dr. Deaton.
Endovascular grafts, often referred to as "stent" grafts, are a minimally invasive technique of repairing AAA first approved for general use in the United States in 1999. The weakened and dilated portion of the aorta is replaced by an artificial artery made of either polyester or polytetrafluoroethylene (also known as Teflon®). Placement of this conduit removes pressure exerted by normal blood flow on the diseased area of the aorta, thus preventing rupture.
"When they are discovered, we can usually fix them with a minimally invasive procedure, a single night stay in the hospital, and a < 1% mortality rate. The difference in the outcome is tremendous," said Dr. Deaton.
Dr. Deaton is a foremost expert in the area of endovascular surgery and is a member of numerous vascular societies and Editorial Boards.