FDA Okays Clinical Trial for Artificial Kidney Device

Blood Purification Technologies has won U.S. Food and Drug Administration (FDA) clearance to begin human clinical trials of its Wearable Artificial Kidney (WAK). Testing will be conducted at several academic medical centers, including the University of Washington and other major universities, the company said in a statement. Specific trial dates were not disclosed.

The Beverly Hills, Calif.-based company is one of three institutions selected for the FDA’s “Innovation” program—a pathway designed to fast-track approvals for devices that treat end-stage renal disease (ESRD). The agency chose three finalists from a pool of 32 applicants and announced the winners in 2012. According to the FDA, more than 500,000 people in the United States suffer from ESRD, and costs associated with the disease topped $29 billion in 2009.

Other winning products include an implantable renal assist device being developed by scientists at the University of California, San Francisco, and a hemoaccess valve system designed by CreatiVasc Medical of Greenville, S.C.

Blood Purification Technologies’ WAK technology offers an alternative to traditional dialysis—a commonly used treatment for kidney failure. While the dialysis industry continues to thrive, the technology surrounding the procedure is antiquated, said WAK’s inventor, Dr. Victor Gura.

“Since its inception, more than 50 years ago, little has changed in the way we deliver dialysis with machines that immobilize patients for many hours,” he said. “On the other hand the WAK has the potential of radically changing the way dialysis is provided and might offer substantial cost reductions, and the hope of improving quality of life and decreasing mortality in dialysis patients.”