Teleflex, a provider of medical devices for critical care and surgery, has announced the US Food and Drug Administration (FDA) 510(k) clearance of a full range of Polysite implantable ports for exclusive distribution in the US under its ARROW brand.
These ports have a low profile, hybrid design that combines a lightweight plastic body and a strong titanium reservoir, and will be available in both pressure injectable and non-pressure injectable options.
Teleflex specialty division president and general manager Linda Beneze noted the ARROW Polysite low profile hybrid ports will further broaden a product line that demonstrates the company’s commitment to enhance patient outcomes, improve safety and drive health economics in the area of interventional access.
"We are proud to add ARROW® Polysite® Ports to our portfolio," Beneze added.
The ARROW Polysite low profile hybrid ports have a lightweight body with an atraumatic profile designed to provide patient comfort, while the strong titanium reservoir is compatible with a range of cytotoxic drugs commonly used in chemotherapy and prevents needle ‘pitting’ experienced with plastic reservoirs.
The ports will be available in 6 Fr. Micro, 7 Fr. Mini, and 8 Fr. Standard sizes with attachable polyurethane catheter.
All sizes are pressure injectable up to 5mL/sec at 300psi and are MR conditional. Each ARROW Polysite port kit contains a Polyperf Safe safety huber needle. This patented positive pressure Huber needle has a removal system designed to reduce the risk of blood reflux and minimize catheter occlusion by maintaining positive flush pressure during one-handed needle removal.