AngioDynamics has received the US Food and Drug Administration (FDA) clearance to market its AngioVac cannula for an extended indication.
The new labeling indicates AngioVac for up to six hours of extracorporeal bypass, during which the device helps remove clots and blockages from the blood.
The AngioVac cannula and circuit, when combined with other manufacturers’ filters, pumps and return cannula, comprise an extracorporeal bypass circuit that facilitates drainage, filtration and reinfusion of blood for up to six hours.
The expandable distal tip of the cannula is actuated by a balloon, and is funnel shaped to facilitate venous drainage when the balloon is inflated.
The novel funnel shape prevents intravascular material from clogging of the cannula and also allows for removal of extraneous material such as fresh, soft thrombi or emboli.
AngioDynamics president and CEO Joseph M. DeVivo said products like AngioVac represent company’s commitment to pioneering new technologies that not only provide a clinical benefit to its customers, but also economic value.
"This expanded indication allows us to grow awareness of the significant morbidity and mortality associated with VTE and the role AngioVac can play in meeting the significant need it presents," DeVivo added.
Earlier in October 2013, the company received CE Mark for AngioVac venous drainage cannula and cardiopulmonary bypass circuit for use during extracorporeal bypass for up to six hours and for removal of fresh, soft thrombi or emboli.