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Medical Devices / Regulatory Affairs / Submissions and Approvals

FDA Expands Indication for AngioDynamics’ AngioVac Cannula

March 13, 2014

The FDA has cleared AngioDynamics’ AngioVac cannula for the removal of fresh, soft thrombi or emboli, the company said Tuesday. The new clearance adds to an earlier indication for up to six hours of venous drainage during extracorporeal bypass.

The 22F, coil-reinforced cannula is balloon-actuated and expandable, with a funnel-shaped distal tip that AngioDynamics says enhances the flow of blood and prevents clogging, while facilitating removal of intravascular material. According to the company, catheter-directed thrombolysis is superior to anticoagulant therapy; the ability to filter that material from blood “may provide an effective alternative, minimizing the potential risks and comorbidities.”

President and CEO Joseph DeVivo said the new indication will allow the devicemaker to “grow awareness of the significant morbidity and mortality associated with [venous thromboembolic disease],” which the company says kills 300,000 in the U.S. every year.

The cannula is used in conjunction with AngioDynamics’ cardiopulmonary bypass circuit, as well as filters, pumps and return cannulae manufactured by other companies. The bypass circuit was granted 510(k) clearance in April 2009. — Lena Freund

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