AngioDynamics Gets FDA Clearance For Pulmonary Embolism Treatment
By Will Feuer
AngioDynamics said the U.S. Food and Drug Administration has cleared its AlphaVac F18 system for the treatment of pulmonary embolism, a kind of blood clot that the company says affects about 900,000 people in the U.S. every year.
AngioDynamics' AlphaVac system was already cleared by the FDA for the removal of thromboemboli from the venous system. The company said the expanded clearance for the treatment of PE broadens the applicability of the device and treatment options for patients.
The expanded clearance comes after a clinical trial reached its primary endpoints and showed a meaningful, favorable reduction in clot burden, said Juan Carlos Serna, AngioDynamics senior vice president of scientific and clinical affairs.
Write to Will Feuer at Will.Feuer@wsj.com
(END) Dow Jones Newswires
April 04, 2024 07:21 ET (11:21 GMT)
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