Expanded FDA clearance for AngioVac

Expanded FDA clearance for AngioVac

AngioVac, when combined with other manufacturers' filters, pumps and return cannula, comprise an extracorporeal bypass circuit.

March 22, 2014
Manufacturing Group
Contract Manufacturing Design/Engineering Devices/Implants/Equipment Industry/Regulations

Albany, N.Y. – AngioDynamics a leading provider of innovative, minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology, today announced the U.S. Food and Drug Administration (FDA) cleared an expanded indication for its AngioVac cannula for venous drainage during extracorporeal bypass for up to six hours to include removal of fresh, soft thrombi or emboli.

"Since its introduction to our portfolio in October 2012, the AngioVac cannula and circuit has shown strong market acceptance across the U.S. due to its ability to improve patient outcomes and reduce the cost of treatment," said John Soto, executive vice president and chief commercial officer. "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)."

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 AngioVac Cannula has a proprietary balloon-actuated, expandable, funnel-shaped distal tip to enhance flow, prevent clogging of the cannula and facilitate en bloc removal of undesirable intravascular material such as fresh, soft thrombi or emboli.

Venous thromboembolic events are a leading cause of morbidity and mortality, and the annual number of VTE-related deaths has been estimated at more than 300,000 across the U.S. Pharmacomechanical therapies and catheter-directed thrombolysis offer many benefits over the current standard of care, anticoagulant therapy; however, these treatments can cause major bleeding complications and a significant number of patients have contraindications. Removal of undesirable intravascular material may provide an effective alternative, minimizing the potential risks and comorbidities associated with these treatments.

"Products like AngioVac represent our commitment to pioneering new technologies that not only provide a clinical benefit to our customers, but also economic value," said Joseph M. DeVivo, AngioDynamics' president and CEO. "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."

Source: AngioDynamics