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# Unibody Endografts Don’t Beat Older Ones: Study
- URL: https://www.fdaweb.com/unibody-endografts-dont-beat-older-ones-study/
- Published: 2023-03-23T12:00:00.000Z
- Updated: 2026-09-14T18:21:47.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5154053

FDA-funded research conducted by the Smith Center for Outcomes Research at Boston’s Beth Israel Deaconess Medical Center has determined that newer unibody aortic stent grafts failed to outperform the older non-unibody devices through a median follow-up period of 3.4 years. A medical center [media statement](https://www.newswise.com/articles/bidmc-research-guides-fda-action-on-common-medical-device?ref=fdaweb.com) says the findings support instituting a longitudinal program for monitoring safety events related to aortic stent grafts.

“There was a suggestion of persistent harm associated with unibody devices compared with non-unibody devices,” said principal investigator **Eric Secemsky**. “In the SAFE-AAA study, the unibody endografts failed to meet noninferiority compared with non-unibody endografts. Our study provides an important example of how real-world data can be used to monitor the safety of products already on the market, and help support regulatory decision-making.”

The researchers looked at data from 87,163 Medicare beneficiaries who underwent aortic stent grafting at more than 2,000 U.S. hospitals between 2011 and 2017\. Following the patients’ outcomes for a median period of 3.4 years, they looked at mortality from all causes after endovascular stent grafting, whether patients’ aneurysms ruptured after their procedures, and whether patients needed secondary intervention after their procedures.

The team reported that at least one of the conditions occurred in 74% of unibody device-treated patients versus 65% of non-unibody device-treated patients. In a subgroup of patients who underwent the procedure more recently, to correspond to the market release of the newest unibody endograft, the incidence of the end-point conditions was 38% among unibody device-treated patients versus 33% among non-unibody device-treated patients.

“The SAFE-AAA analysis evaluating unibody systems to comparator devices confirmed safety issues associated with unibody endografts but also suggests potential concerns with the newest iterations of the devices,” Secemsky said. “Because endovascular aneurysm repair has become the dominant intervention to treat an abdominal aortic aneurysm, it is important that the endograft device class as a whole be closely scrutinized for adverse safety events. Especially with concerns over specific device designs, enhanced surveillance programs can greatly improve the understanding of device safety.”

As a result of the study findings, in conjunction with previous studies and device safety data, FDA has approved an updated device label that includes the possible long-term risks associated with certain unibody devices. The agency also has recommended that healthcare providers consider using alternative devices when possible. And it required the manufacturer to conduct a long-term market safety study.

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