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FDA approves endograft stapling system
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The FDA has approved marketing of a system designed to repair failed or problematic aortic endografts, according to a press release.
“Leakage between the top end of the endograft and the aorta wall is a known complication of endograft implants that can be successfully treated,” Christy Foreman, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, said in a press release. “The Aptus Endostapling System provides a less invasive option than open surgery to access and repair these leaks.”
A cassette of nickel-cobalt corkscrew-shaped staples that is loaded into a long, thin, tube-like delivery catheter, the Aptus EndoStapling System (Aptus Endosystems Inc.) is for use in patients whose endovascular grafts have moved, exhibit endoleaks or are at risk for these complications. Inserted into an artery in the leg, the catheter is directed to the failed endograft where the staples are used around the top edge to anchor the device and repair the endograft-artery seal.
The FDA’s decision to approve marketing was based on data from 154 patients who were implanted with 810 endostaples and monitored with routine CT scans. By the end of 1 year, follow-up results showed that none of the endostaples fractured and no patients experienced endograft movement.
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