Bleeding Risks Still A Concern For Patients With Endologix Stent Grafts: FDA Advisory Panel
Company’s latest design fails to convince panel leakage issues have been fixed
The US agency’s Circulatory System Devices Panel found type III endoleaks are still a problem for abdominal aortic aneurysm patients treated with the newest Endologix stent graft, though for some the benefits still outweigh the risks. The panel advised that all patients, however, should continue getting annual screenings.
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Postmarket monitoring continues to show a consistent risk of type III endoleaks in patients with Endologix AFX grafts.
The US FDA has stopped publishing its list of approvals and denials of premarket approval applications (PMAs) and humanitarian device exemptions (HDEs) in the Federal Register on a quarterly basis. The agency says the change will save money and resources.
Biden Pledges A Billion COVID-19 Tests, Announces Plan Requiring Private Insurers To Pay For At-Home Diagnostics
The Biden administration announced on 13 January that it’s purchasing an additional 500 million COVID-19 tests to be distributed free to any American wanting one, bringing the total to 1 billion tests procured.