CE Mark for AngioDynamics’ AngioVac

MIS device company, AngioDynamics has gained 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.

Background

The annual number of Venous thromboembolic event (VTE) -related deaths has been estimated at more than 500,000 across the European Union, making this a leading cause of morbidity and mortality. While so-called pharmacomechanical therapies and catheter-directed thrombolysis offer many benefits over anticoagulant therapy, the current standard of care, these treatments can cause major bleeding complications and a significant number of patients have contraindications.

Directly addressing the risk of comorbidities associated with other treatments 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. This enhances flow, prevents clogging of the cannula and facilitate en bloc removal of undesirable intravascular material.

Company comments

“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.”

“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.”

Source: AngioDynamics, Inc., Globe Newswire