Device Dossier
SmartPort+ Titanium Implantable Port with Vortex Technology and BioFlo Catheter with Endexo Technology - Vascular port/catheter
Device Dossier for SmartPort+ Titanium Implantable Port with Vortex Technology and BioFlo Catheter with Endexo Technology - Vascular port/catheter…
- GMDN category: Vascular port/catheter
Intended purpose
The ports are indicated for patients who require long-term access to the central venous system for blood specimen withdrawal and administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products, as well as the administration and adequate removal of nuclear medicine. When used with power injectable needles, the ports are indicated for power injection of contrast media.
Functional description
SmartPort+ is a subcutaneously implantable venous access device consisting of a port body (with one reservoir) and a BioFlo catheter (single lumen, radiopaque, attached or detached). The port is accessed using a non-coring needle (Huber) which is passed through the skin and into the self-sealing silicone septum covering the reservoir. SmartPort+ is supplied with a number of components to assist in surgical implantation, including: introducer needle, peelable sheath introducer, guidewire, etc.