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The DermaPort Ported Vascular Access System (PVAS™) is indicated for long-term (greater than 30 days) vascular access for hemodialysis and apheresis. The system is inserted percutaneously and typically placed in the internal jugular vein of an adult patient. The subclavian vein is an alternate catheter insertion site.

The Ported Vascular Access System (PVAS™) has been developed to support central vascular access for hemodialysis and apheresis. This application is for the addition of a 15.5F catheter to the PVAS system and a dilating lead-in to replace the sheath during insertion. The PVAS port consists of a percutaneous tubular conduit, through which a standard 14.5F or 15.5F polyurethane hemodialysis catheter enters the subcutaneous tunnel. An integral seal surrounds the catheter and prevents microbial migration along the catheter. The PVAS port is enclosed by a silicone anchor that braces the assembly to the skin, and an associated brake holds the catheter in place within the port. A tissue integrating biomaterial surrounds the port, providing anatomical fixation and prevention of microbial migration in a manner analogous to the Dacron cuff of a tunneled catheter.

The DermaPort Percutaneous Vascular Access System (PVAS™) is indicated for long-term (greater than 30 days) vascular access for hemodialysis and apheresis. The system is inscrted percutaneously and the catheter is typically placed in the internal jugular vein of an adult patient. The subclavian vein is an alternate catheter insertion site.

The DermaPort Percutaneous Vascular Access System (PVAS) is designed to facilitate catheter placement, reposition, and exchange procedures while maintaining the catheter attachment, bacterial barrier, and fixation functions of the predicate catheter fibrous cuff. The main component of the PVAS is a metal port which is implanted into the subcutaneous tunnel at the catheter exit site on the chest wall. The hemodialysis catheter passes through the metal port which acts as a percutaneous conduit, into the subcutaneous tunnel, and then into the central venous system in the usual fashion. The metal surface of the PVAS port has a porous, tissue integrating coating which allows ingrowth of tissue to anchor the PVAS port. The PVAS port holds the hemodialysis catheter in place. The DermaPort Percutaneous Vascular Access System (PVAS) consists of the following types of components: - 1. Implanted Hemodialysis 14.5 F Catheter (24 cm, 28 cm or 32 cm lengths) - Guidewire; 0.038 inch (70 cm or 100 cm lengths) 2. - 3. 16F Tcaraway Set Griplock Hub - 4. 12F Polyethylene Dilator - న్. 14F Polyethylene Dilator - 6. Clear Female Dust Cover - 7. Injection Caps - 8. 18 GA x 2.7" Cyrolite Introducer Needle - 9. Tunneler with Tri ball tip - 10. Tunneler Sleeve - 11. DermaPort Blade - 12. Commercially available alcohol pad - 13. Commercially available adhesive wound dressing - 14. Peel-away Sheath - 15. DermaPort Percutaneous Vascular Access System (PVAS) Port The catheter is identical to the Hemolilow catheter, with the exception that the fabric cuff on the HemoFlow catheter is omitted. The HemoFlow catheter is cleared to market by the FDA via 510(k) number K994105. The Percutancous Vascular Access System (PVAS™) has been developed to support central vascular access for hemodialysis and apheresis. The PVAS port consists of a percutaneous tubular conduit, through which a standard 14.5F polyurethane hemodialysis catheter enters the subcutaneous tunnel. An integral seal surrounds the catheter and prevents microbial migration along the catheter. The PVAS port is enclosed by a silicone anchor that braces the assembly to the skin, and an associated brake holds the catheter in place within the port. A tissue integrating biomaterial surrounds the port, providing anatomical fixation and prevention of microbial migration in a manner analogous to the fabric cuff of a tunneled catheter.