Dialysis Access Device Cleared by FDA

A new dialysis access device has been cleared by the U.S. Food and Drug Administration (USA) following an expedited review, which is granted when a device offers breakthrough technology, significant advantages over existing alternatives, and its availability is in the best interest of the patient.

Called LifeSite, the access device is implanted subcutaneously and accessed via the
buttonhole technique by inserting a standard dialysis needle. The system provides high flow rates, reduces the risk of infection, is unobtrusive, and can be used immediately following implantation since it requires no maturation time. LifeSite is the product of Vasca, Inc. (Tewksbury, MA, USA). The company notes that vascular access has long been called the Achilles heel of hemodialysis because of complications such as infection and thrombosis. LifeSite has received the CE Mark for both hemodialysis and peritoneal dialysis.

The LifeSite system is the first new development in dialysis access treatment in nearly a decade, representing a new alternative for vascular access, says Dr. Steven Schwab, Duke University Medical Center (Durham, NC, USA), chairman of the Dialysis Outcomes Quality Initiative (DOQI) Committee on Vascular Access.