The US Food and Drug Administration (FDA) has issued a MedWatch recall notice for all AFX Endovascular AAA Systems by Endologix following a voluntary recall action by the company in July. The notice, ...
Endologix is recalling all of its AFX endovascular abdominal aortic aneurysm (AAA) systems after continued reports of type III endoleaks. The US Food and Drug Administration (FDA) has identified this ...
Following discussions with the Food and Drug Administration, Endologix, Inc. (NASDAQ:ELGX) has issued updating information to physicians concerning the AFX Endovascular AAA System. The letter ...
Patients who have undergone endovascular aortic repair (EVAR) of abdominal aortic aneurysm (AAA) need lifelong surveillance, including imaging, the US Food and Drug Administration (FDA) advises.
An endovascular stent graft for abdominal aortic aneurysm (AAA) that has had a troubled safety history does not meet noninferiority compared with other commercially available options, according to the ...
Dr. Matt Thompson, Chief Medical Officer of Endologix Inc. commented, “On September 28, 2017, the FDA issued a letter to health care professionals (“HCPs”) regarding Type III endoleaks after ...
A voluntary hold on production of its top seller has been lifted, allowing for shipments to return to normal. Endologix shares collapsed 26% on Dec. 27 after management put a temporary hold on ...
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