FDA adds another artificial kidney to its Expedited Access Pathway program

Shuvo Roy holds a prototype of a surgically implantable artificial kidney.--Courtesy of Susan Merrell

A surgically implanted artificial kidney under development at the University of California, San Francisco (UCSF), has been accepted into the FDA's Expedited Access Pathway (EAP) for "breakthrough" technologies that debuted just 6 months ago.

Additionally, the coffee-cup-sized device received a $6 million grant from the National Institute of Biomedical Imaging and Bioengineering that is part of the National Institutes of Health. Researchers are aiming for the device to be a viable alternative to kidney transplants or dialysis for patients with end-stage kidney disease, the university said in a press release.

FierceMedicalDevices reported earlier this week that a neuromodulator made by PathMaker Neurosystems of Boston and a wearable artificial kidney from Blood Purification Technologies were the first devices accepted into the regulatory agency's EAP program. UCSF researchers learned in September their device was to be included in the fast-track program.

"We aim to conduct clinical trials on an implantable, engineered organ in this decade, and we are coordinating our efforts with both the NIH and the U.S. Food and Drug Administration," Shuvo Roy, a bioengineer at UCSF, said in a statement. Dr. William Fissell, a nephrologist at Vanderbilt University, is co-leading the development with Roy.

One of the two key components of the device is a silicon nanofilter that removes toxins, salts, some small molecules, and water from the blood. The design was based on manufacturing methods used in the production of semiconductor electronics and microelectromechanical systems. The second key component is a "bioreactor" that contains human kidney tubule cells embedded within microscopic scaffolding that perform metabolic functions and reabsorb water from the filtrate to control blood volume.

When surgically implanted, the artificial kidney is designed to be connected internally to the patient's blood supply and bladder and placed near the patient's own kidneys, which are not removed. The device won't require immunosuppresive therapy that is required following traditional kidney transplant surgery, the researchers said.

It's estimated there are about 600,000 people in the U.S. who suffer from end-stage renal disease, which has a mortality rate of 20%.

The FDA's expedited pathway was established for devices intended "to treat or diagnose a life-threatening of irreversibly debilitating disease or conditions" that offer a clinically meaningful advantage over approved alternatives. In addition, for an investigational device to earn EAP status, the agency must approve its data development plan.

- check out UCSF's release