> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Urges Follow-up on Endovascular Aortic Repair
- URL: https://www.fdaweb.com/fda-urges-follow-up-on-endovascular-aortic-repair/
- Published: 2022-02-28T12:00:00.000Z
- Updated: 2026-09-14T17:34:28.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5151253

FDA has sent a [letter to healthcare professionals](https://www.fda.gov/medical-devices/letters-health-care-providers/fda-advisory-panel-recommendations-lifelong-surveillance-and-long-term-postmarket-data-collection?ref=fdaweb.com) that emphasizes the importance of lifelong surveillance, including imaging, for patients with abdominal aortic aneurysm (AAA) endovascular aortic repair (EVAR) using stent graphs. “Regular imaging surveillance, within 30 days of EVAR and annually thereafter, may help identify adverse events such as endoleaks, device migration, loss of patency, and failure of aneurysm sac regression before the occurrence of potentially serious and life-threatening adverse events,” the agency says.

FDA’s letter supports recommendations made during an 11/3/2021 Circulatory System Devices Panel of the Medical Devices Advisory Committee [meeting](https://www.fda.gov/advisory-committees/advisory-committee-calendar/november-2-3-2021-circulatory-system-devices-panel-medical-devices-advisory-committee-meeting?ref=fdaweb.com#event-materials) that discussed the long-term safety and effectiveness of endovascular stent grafts for AAA treatment, how to strengthen data collection on real-world device performance, and input on the outcomes that are most important to capture during long-term follow-up. The panel concluded that:

- EVAR continues to be a safe and effective treatment option for appropriately selected AAA patients.
- Patients should complete follow-up visits 30-days post implantation and lifelong annual follow-up thereafter. As is outlined in current professional society guidelines, a six-month follow-up visit should occur if concerns are identified from imaging at 30-day follow-up.
- A real-world surveillance system should be created to collect data through 10 years post-EVAR.

FDA notes that in the U.S., EVAR has largely replaced open surgery for AAA because of lower perioperative mortality rates (occurring within 30 days after surgery) compared with surgical repair. “However, this survival advantage is not maintained long-term; mortality rates are comparable between EVAR and open surgery three to five years after the procedure,” it says.