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The HeRO vascular access device is intended for use in maintaining long-term vascular access for chronic hemodialysis patients who have exhausted peripheral venous access sites suitable for fistulas or grafts. The HeRO vascular access device is indicated for end stage renal disease patients on hemodialysis who have exhausted all other access options. These catheter-dependent patients are readily identified using the K/DOQI guidelines as patients who: - Have become catheter-dependent or who are approaching catheter-dependency (i.e., have exhausted all other access options, such as arteriovenous fistulas and grafts). - Are not candidates for upper extremity fistulas or grafts due to poor venous outflow as determined by a history of previous access failures or venography. - Are failing fistulas or grafts due to poor venous outflow as determined by access failure or venography. - Have poor remaining venous access sites for creation of a fistula or graft as determined by ultrasound or venography. - Have a compromised central venous system or central venous stenosis (CVS) as determined by history of previous access failures, symptomatic CVS (i.e., via arm, neck, or face swelling) or venography. - Are receiving inadequate dialysis clearance (i.e., low Kt/V) via catheters. K/DOQI guidelines recommend a minimum Kt/V of 1.4.

The HeRO device is a non-autogenous (i.e., synthetic) vascular access composed of four components: a catheter component, a pre-connected graft assembly, a crimp ring, and a sleeve. The catheter component is made of radiopaque silicone and contains reinforcing filaments that impart kink and crush resistance. The catheter is provided in two different lengths (referred to as left side and right side) to accommodate anatomical variations. During surgery, the catheter length is sized to fit the patient by peeling back the nylon filament and cutting the catheter. The pre-connected graft assembly is a conventional ePTFE hemodialysis graft that has been attached to a titanium connector. The titanium crimp ring is used during surgery to secure the catheter to the graft assembly. The silicone sleeve is placed during surgery to impart kink resistance of the catheter at the connector and to cover the metal crimp ring in silicone. Additionally, a reusable stainless steel crimp tool is provided to compress the crimp ring for securing the catheter component to the graft assembly during surgery. The crimp tool is provided non-sterile and is steam sterilized before each use.