AngioDynamics Receives FDA Clearance for Xcela Plus Port Family With PASV Technology

AngioDynamics

, 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,