Endologix has recalled 5,403 stent graft devices distributed in the U.S. since August 2015. These devices have attributed in 47 cases of polymer leak and three deaths.
About the Endologix Stent Graft
According to reports, the Endologix stent graft is an endovascular aneurysm repair device. Unlike other devices of its kind, the Endologix uses a liquid polymer intended to create a low-profile graft with durable aortic seals that adapt to the anatomy of each patient. However, the design also exposes patients to the risks of polymer leaks, according to the company.
The Dangers of the Endologix Stent Graft
In 2018, the Endologix attributed to 47 cases of polymer leak and three deaths to excessive catheter manipulation and other user errors. Last month, Endologix revised its position in an Urgent Medical Device Correction, saying that “a material weakness adjacent to the polymer fill channel” is causing the leaks when it comes under pressure.
According to the company’s statement published Monday:
- 112 patients have suffered an adverse event linked to the fault or a little less than 1% receiving the device.
- 5 patients have died.
- Other patients have suffered multi-organ failure, cardiac arrest, tissue necrosis, and other events.
- The failure rate rose from 0.65% to 0.88% over the past two years.
The FDA’s Response
Despite the failure rate, all Endologix devices will remain on the market. The FDA is asking doctors to factor the risk of polymer leaks into their assessments of the pros and cons of Ovation iX and other approaches. Endologix is advising doctors to monitor for sudden low blood pressure as a possible sign that the polymer is leaking.
Endologix is also working on a newer Alto graft which won FDA approval in March. The company is hoping to transition to Alto by November. CEO John Onopchenko believes that the Alto will “meaningfully decrease polymer leak rates.”
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