The new labeling indicates AngioVac for up to 6 hours of extracorporeal bypass, during which the device helps remove clots and blockages from the blood. European regulators granted similar longer-term approval for AngioVac in October 2013.
AngioVac, which is comprised of a cannula and circuit, has been on the market since October 2012. The device pairs with existing filters, pumps and return cannula to form a total bypass system that provides drainage, filtering and re-infusion of blood.
"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," AngioDynamics president & CEO Joseph DeVivo said in prepared remarks.
The new clearance marks the 2nd FDA win for AngioDynamics this month, counting 510(k) clearance for the company’s BioFlo BioFlo DuraMax chronic hemodialysis catheter. AngioDynamics also announced last week that it would take charge of regulatory efforts for the Celerity tip location technology, which is owned by distribution partner Medcomp. The Celerity system was just rejected by the FDA, but AngioDynamics believes it can apply a little finesse and get the application back on track.
ANGO shares have been pretty flat over the past month and today’s AngioVac announcement did little to move them. The stock was trading at $15.54 as of about 12:25 p.m., an increase of 0.1% on the day. Shares have gained 0.3% over the last month, but are down 9.7% since the start of the year.