U.S. and Canada Clear for AngioDynamics’ Implantable Ports

Albany, N.Y.-based AngioDynamics Inc. has received two key port product clearances. The U.S. Food and Drug Administration has granted 510(k) clearance for the Xcela Plus Port family. The devices have pressure activated safety valve (PASV) technology made by Navilyst Medical, an AngioDynamics company. Health Canada also granted AngioDynamics its Medical Device License to market and sell the Smart Port CT family of power-injectable ports, which feature Vortex port technology.

The Xcela Plus Port with PASV valve technology is expected to launch in the first quarter of AngioDynamics’ fiscal year 2014. The PASV technology has been in use for more than a decade in various ports and peripherally inserted central catheters (PICC). 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, which would pose less patient risk and afford greater economic efficiency to the hospital.

“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,” said Chuck Greiner, vice president of the company’s 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.

Vortex port technology is designed to achieve better patient outcomes, fewer complications, more efficient use of nursing time and lower expenses. The port’s round chamber allows fluid to reach all surfaces in the chamber, helping eliminate dead spaces and resisting sludge buildup, while a tangential outlet creates an efficient flushing action to thoroughly cleanse the entire reservoir, claims the company. The most common complications associated with the use of vascular access ports are occlusions and thrombus formations. According to AngioDynamics, an average 73 percent reduction in occlusion rates has been shown with the use of Vortex technology, compared to conventional ports.

Implantable ports are medical devices implanted under the skin that facilitate long-term delivery of medication and access to a patient’s vascular system. The Smart Port CT family of power-injectable ports includes standard, low-profile and mini model options for repeated treatments such as chemotherapy, as well as for use with computed tomography (CT). Each model is made from lightweight titanium and is engraved for better identification. These ports, which also have FDA clearance and the CE mark from the European Union, are clinically indicated for power-injections up to 5mL/sec and a 300 psi pressure limit setting.

AngioDynamics makes minimally invasive medical devices.