AngioDynamics Receives FDA Clearance for Expanded Cannula Indication

AngioDynamics has obtained U.S. Food and Drug Administration (FDA) approval for an expanded indication of its AngioVac cannula.
The expanded indication of AngioVac cannula for venous drainage during extracorporeal bypass for up to six hours includes removal of fresh, soft thrombi or emboli.

When combined with other manufacturers’ filters, the AngioVac cannula and circuit pumps and return cannula, comprising 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.

Its 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, the Latham, N.Y.-based company claims.

Since its introduction to the company’s portfolio in October 2012, the AngioVac cannula and circuit has shown strong market acceptance throughout the United States due to its ability to improve patient outcomes and reduce treatment costs, AngioDynamics executive vice president and chief commercial officer John Soto said.

“The expanded FDA clearance, which includes the removal of fresh, soft thrombi or emboli during extracorporeal bypass, makes this a more powerful tool for physicians in the U.S., where an estimated 1 million people are affected by venous thromboembolic disease (VTE),” he noted.

AngioDynamics executives hope the device will help reduce the incidences of venous thromboembolic events that kill close to 300,000 Americans annually.

“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,” President/CEO Joseph M. DeVivo said.

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.