FDA 510(k) Clearance For AngioDynamics Xcela Plus Port Family

Vascular device specialist AngioDynamics, has received FDA 510(k) clearance for the Xcela Plus Port family through its Navilyst company.

Background

In a press release, AngioDynamics says the Xcela Plus Port with Pressure Activated Safety Valve (PASV) Technology is the first proximally-valved Computed Tomography (CT) port in the market. Following this approval it is expected to be made available commercially in the U.S. during 2014.

The PASV valve technology has more than 10 years of clinical experience with ports and Peripherally Inserted Central Catheters (PICC). AngioDynamics tells us that in a randomized, prospective clinical study, ports with PASV valve technology were associated with significantly less nursing time and fewer instances of poor blood return as compared to non-valved ports. The bi-directional PASV valve is designed specifically to reduce blood reflux on the inside of the catheter and may reduce the need for heparin based care and maintenance, providing less patient risk and greater economic efficiency to the hospital.

Company comments

“With Xcela Plus Ports, we bolster our significant portfolio of vascular access products while meeting a large un-met need for a better valved port system,” said Chuck Greiner, Vice President of AngioDynamics’ Vascular Access Business. “This clearance builds on our promise to leverage differentiating technologies, and we look forward to further innovations such as the integration of our BioFlo technology into our port and dialysis product lines.”

Source: AngioDynamics, Inc., Globe Newswire