Provider of minimally invasive medical devices used in image-guided procedures, AngioDynamics has obtained US Food and Drug Administration (FDA) approval for an expanded indication for 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.
AngioDynamics executive vice-president and chief commercial officer John Soto said since its introduction to company's portfolio in October 2012, the AngioVac cannula and circuit has shown strong market acceptance across the US due to its ability to improve patient outcomes and reduce the cost of treatment.
"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 US, where an estimated one million people are affected by venous thromboembolic disease (VTE)," Soto said.
The device will hopefully go a long way in reducing the incidences of venous thromboembolic events that cause close to 300,000 deaths annually across the US.
AngioDynamics president and CEO Joseph M DeVivo said products such as AngioVac represent company's commitment to pioneering new technologies that provide a clinical benefit to its customers.
"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 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.