Aug 23 (HeartCenterOnline) - A system for repairing abdominal aortic aneurysms (AAA) that was recalled earlier this year is back on the market. Guidant Corporation recently announced that its ANCURE Endograft System has received FDA approval for full market release. The system was recalled in March 2001 after an internal audit by Guidant revealed some potential problems with the device.

An aortic aneurysm is the dilation, bulging or ballooning out of part of the wall of the aorta, the blood vessel that carries oxygen-rich blood from the heart to the body. The thoracic aorta supplies the upper body and the abdominal aorta supplies the lower body. An abdominal aortic aneurysm is an aneurysm that occurs somewhere along the abdominal aorta, which travels the entire length of the abdomen. Abdominal aortic aneurysms are the most common type of aortic aneurysms, comprising up to 75 percent of cases.

Guidant's ANCURE Endograft System is a catheter-based treatment for repairing abdominal aortic aneurysms and preventing a ruptured aneurysm. Ruptures are painful events that cause massive internal bleeding and are fatal in 80 percent of cases.

While small abdominal aortic aneurysms may be treated with medication, those larger than 5 centimeters may often require surgery. Traditional surgery requires a long incision to open the abdomen. The bulging section of the aorta is then excised (surgically removed), and the remaining blood vessel is reconnected.

Catheter-based treatments, such as ANCURE, are another option. This approach enables physicians to reach an aneurysm through a catheter rather than requiring an incision to open the abdomen. Once the aneurysm has been reached via a catheter, the ANCURE system can be used. The ANCURE system involves a patch of synthetic material that is placed across the aneurysm and anchored on either end by wire hooks that attach to the vessel wall. The entire device is called an endograft or stent-graft and it provides a channel for blood to flow through the vessel without entering the aneurysm. Other systems use different types of materials or different methods of securing the endografts in the aorta. The procedure is also known as endoluminal aortic stent-grafting or endovascular repair.

The ANCURE Endograft System was originally approved for marketing in the U.S. in September 1999. The FDA sent a letter to physicians in April 2001 explaining the reasons behind the March recall. The letter states that an internal Guidant audit found a series of potential problems, including a failure to report manufacturing changes, adverse events and device malfunctions to the FDA. "The manufacturer told FDA that an internal audit revealed problems with their complaint handling system, manufacturing quality systems, documentation procedures and training," reads the FDA letter.< p> The Guidant press release announcing the FDA approval included the following statement from Guidant's President of Endovascular Solutions Beverly Huss: "We are extremely pleased about beginning the full commercial release of our ANCURE system. We are prepared to return the ANCURE system to the market this quarter. We also appreciate the FDA's cooperation in working with us to return this important therapy to physicians and patients."

More information can be found by visiting the following HeartCenterOnline topic centers and encyclopedia articles:
Aortic Aneurysm
Catheter Based Procedures
The Aneurysm Center
The Cardiac Catheterization Center

Other news articles of interest can be found at the following links:
An update on the endovascular approach to treating aneurysms (May 25, 2001)
Endovascular grafts improve outcome in ruptured aortoiliac aneurysms (Nov 9, 2000)
American Heart Association issues aneurysm guidelines (Oct 30, 2000)
New technique may cut abdominal aneurysm deaths (July 4, 2000)

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