US-based invasive medical devices provider AngioDynamics has received 510(k) approval from the US Food and Drug Administration (FDA) for its Xcela Plus Port family with Pressure Activated Safety Valve (PASV).
Claimed to be the first proximally-valved CT port on the market, the Xcela Plus Port with PASV Valve Technology will be commercially available in the US in the first quarter of the company’s fiscal 2014.
AngioDynamics Vascular Access Business vice president Chuck Greiner said with Xcela Plus Ports, the company strengthens its portfolio of vascular access products, while meeting a large un-met need for a better valved port system.
"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," Greiner added.
During a randomised, prospective clinical study, ports with PASV valve technology were linked with significantly less nursing time and fewer cases of poor blood return as against non-valve ports.
Designed to reduce blood reflux on the inside of the catheter, the bi-directional PASV valve may also reduce the need for heparin-based care and cause less risk for patients.
This technology has more than a decade of clinical experience with ports and PICCs, the company claimed.
Meanwhile, AngioDynamics also received a license from the Medical Device License from Health Canada to market and distribute the Smart Port CT family of power-injectable ports that feature Vortex port technology.
AngioDynamics international senior vice president, general manager Stephen McGill said: "We are excited to be able to build upon our international successes with BioFlo PICC in the Canadian market with the introduction of Smart Port."
The Smart Port CT portfolio of power-injectable ports comprises regular, low-profile and mini model options for repeated treatments, such as chemotherapy, besides use with computed tomography (CT).
Each of the models come with a light-weight, titanium design and a CT-engraved port body to enable better identification.
These ports, which have received 510(k) clearance from FDA and are CE Marked for Europe, are indicated for power-injections up to 5mL/sec and a 300 psi pressure limit setting.