The move follows a halt to unrestricted sales of the stent grafts and a voluntary recall of all existing inventory that the Irvine, Calif.-based company announced earlier this month.
“The notification from GMED is a regulatory action and is not in response to any new information beyond our recent FSN. This action is consistent with our previously articulated plans for the Nellix system and does not affect other Endologix products. We remain steadfast in our commitment to patient safety and believe in the transformational potential of Nellix,” Endologix chief medical officer Dr. Matt Thompson said in a press release.
The action came after data from Nellix publications left the company “concerned that outcomes are suboptimal when the system is used outside current instructions for use,” chief medical officer Dr. Matt Thompson said earlier this month.
To ensure the devices aren’t being used outside their indications, all cases will now be pre-screened by a panel of doctors and supported by the company’s clinical specialist, which aligns the company with guidelines issued by the European Society for Vascular Surgery, Endologix said.
Endologix added that it doesn’t expect the suspension to impact its previous financial guidance for 2019.
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