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AngioDynamics Announces FDA Clearance For Xcela Plus Port Family With PASV Technology

ALBANY, N.Y., June 27, 2013 (GLOBE NEWSWIRE) -- AngioDynamics (Nasdaq:ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology, announced it has received two key port product clearances. The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Xcela Plus Port family, with Pressure Activated Safety Valve (PASV) technology to Navilyst Medical, an AngioDynamics company. Additionally, AngioDynamics has received the Medical Device License from Health Canada to market and sell the Smart Port CT family of power-injectable ports, featuring Vortex port technology.

The Xcela Plus Port with PASV Valve Technology is the first proximally-valved CT port in the market and is expected to be available commercially during the Company's Fiscal Year 2014 first quarter. The PASV valve technology has more than 10 years of clinical experience with ports and PICCs. 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. i 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.

"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."

Smart Port is now officially available in Canada, and the launch supports an existing contract with HealthPRO, Canada's national healthcare group purchasing organization (GPO). HealthPRO is invested in Canada's public healthcare system by representing the purchasing interests of hospitals, provincial authorities and Shared Service Organizations (SSOs).

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