This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: Endologix PowerLink® System
Applicant: Endologix, Inc.
Address: 13900 Alton Parkway, Suite 122, Irvine, CA 92618
Approval Date: October 29, 2004
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf4/P040002a.pdf
What is it? The Endologix PowerLink® System includes an endovascular graft and its delivery system used to treat an abdominal aortic aneurysm (AAA) during a surgical procedure called endovascular repair. An AAA is a bulge or ballooning that occurs in the body’s largest artery (the aorta) as it passes through the abdomen. The bulge is caused by a thinning or weakening of the wall of the artery.
The Powerlink® System is a Y-shaped stent graft made out of a fabric tube of synthetic material called ePTFE. It is called a stent graft because it has a metallic structure (stent) attached inside the graft for full support.. The Powerlinkl® System is placed within the aorta to treat an AAA by sealing it off from the pressure of the artery.
How does it work? The Powerlink® System can prevent further growth and possible rupture of an AAA.
- The entire Powerlink® stent graft is compressed into a long, thin plastic tube called a delivery catheter.
- The surgeon inserts a thin wire into one the femoral arteries through a small cut in the groin area of the patient’s leg.
- The delivery catheter is inserted and advanced over the wire into position in the aorta.
- Once the tube is in position, the graft is released and expands to seal the aneurysm off from the rest of aorta.
When is it used? The Endologix PowerLink® System is used when a patient has an (AAA) and has been found to be an appropriate candidate for endovascular repair.
What will it accomplish? The Endologix PowerLink® System should benefit patients with an AAA by preventing further growth and rupture of the aneurysm. Because the surgeon makes smaller cuts, the Powerlink® System may result in:
- less discomfort
- a shorter hospital stay
- faster recovery
When should it not be used? Although there are no known contraindications for use, not all patients are candidates for treatment with an endovascular graft. The device should not be used in patients who are:
- unable to undergo the necessary preoperative and postoperative imaging and implantation studies
- sensitive to, or allergic to the device materials
Additional information: Summary of Safety and Effectiveness and labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p040002