AngioDynamics (NSDQ:ANGO) celebrated 2 regulatory wins this week, an FDA 510(k) clearance for its Xcela Plus Port family and a nod from Canadian regulators for its Smart Port Power-Injectable Ports.
The Albany, N.Y.-based company is touting the U.S.-cleared port family alongside a new pressure-activated safety valve that was developed by company subsidiary Navilyst Medical. AngioDynamics calls these 2 combined technologies the 1st proximally-valved CT port system in the market, saying it plans to begin distribution in Q1 2014.
"With Xcela Plus Ports, we bolster our significant portfolio of vascular access products while meeting a large unmet need for a better valved port system," vascular access president Chuck Greiner said in prepared remarks.
In Canada, the SmartPort has already been made available to healthcare providers through an existing contract with HealthPRO, the national healthcare group purchasing organization.
AngioDynamics paid $372 million for Navilyst in early 2012, in a deal CEO Joe DeVivo told MassDevice.com at the time was a "reset button" for the company.