AngioDynamics achieves CE approval for AngioVac

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AngioDynamics (Nasdaq:ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology, today announced EU CE Mark approval for its AngioVac venous drainage cannula and cardiopulmonary bypass circuit for use during extracorporeal bypass for up to six hours. Under the CE Mark approval the AngioVac cannula is also approved for removal of fresh, soft thrombi or emboli.

"The AngioVac cannula and circuit have shown great promise in improving patient outcomes and reducing the cost of treatment when dealing with the removal of soft thrombus," said John Soto, Senior Vice President of AngioDynamics' Global Peripheral Vascular Franchise. "CE Mark approval makes this powerful tool available to physicians across the EU."

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.

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 500,000 across the European Union.1 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. The en bloc removal of undesirable intravascular material may provide an effective alternative, minimizing the potential risks and comorbidities associated with these treatments.

"We recently exhibited the AngioVac cannula and circuit at the congress  of the Cardiovascular and Interventional Radiological Society of Europe (CIRSE), and the reception was very encouraging," said Stephen McGill, Senior Vice President and General Manager of AngioDynamics' International Business. "AngioDynamics has established itself as a leader and innovator in delivering minimally-invasive, image-guided solutions to interventional radiologists, vascular surgeons, cardiologists and surgical oncologists, and the AngioVac devices continue that tradition."

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