Initial clinical results with the LifeSite Hemodialysis Access System

The LifeSite Hemodialysis Access System is a subcutaneous valve with an internal pinch clamp that is actuated with a standard 14-gauge dialysis needle, connected to a single lumen cannula placed in the central venous circulation for hemodialysis (HD).

The LifeSite System (2 valves) was implanted in 23 patients with immediate dual-needle HD use. The cannulas were placed in either the jugular or the subclavian veins and were connected to the subcutaneous valves located in the upper chest area.

The mean duration of device survival for the LifeSite System was 6.8 +/- 0.97 months. During this period, the device achieved prescription HD blood flow rates averaging 384.7 +/- 78.5 mL/min with a venous pressure of 223.2 +/- 60.3 mm Hg. After 125 patient months, device removal because of infection was at a rate of 2.5 per 1000 days, and there were no devices removed because of poor flow. The average Kt/V for these patients was 1.51.

This preliminary clinical study has validated the applicability of the LifeSite Hemodialysis Access System as an access for HD. It is easily implanted and easily used, provides safe and effective dialysis, and is well accepted by patients. It should be especially useful as a bridge device to allow for maturation of a native fistula and will provide an alternative for long-term use in patients in whom a peripheral dialysis access is not feasible.