The U.S. Food and Drug Administration announced last week that it has chosen three products for patients with end-stage renal disease to participate in the second phase of its new Innovation Pathway. The new project is designed to speed up the approval process of new devices by engaging with innovators much earlier.

“We found ESRD a natural fit given that patients have few options” for treatment, said Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health. The agency said it chose to focus the second phase of the project on ESRD because it is a growing public health concern, and it is expensive to treat. And because it is managed almost entirely by medical devices, ESRD patients would benefit greatly from technological advances.

And many in the renal community agree. “Basically I’m cheering, because this is a drastic change in the way the FDA does business,” said Victor Gura, MD, the inventor of the artificial wearable kidney chosen for the FDA program, and an associate clinical professor at the David Geffen School of Medicine, University of California, Los Angeles. Gura told NN&I he had planned on getting the device approved in another country before applying for marketing approval from the FDA. The U.S. approval process is longer and more complex than most countries, he said. But the new Innovation Pathway “radically changes the whole picture,” Gura said. “Now pathway to approval is much quicker.”

The agency received 32 applications in response to a request for applications in January. “The response from innovators exceeded our expectations and demonstrates that there is a desire from developers of innovative technologies for earlier and more collaborative agency interaction,” said Shuren.

The Winners
The FDA selected the following three products for the program.

Wearable Artificial Kidney (WAK) in development by Blood Purification Technologies Inc. of Beverly Hills, Calif.
Gura said he has been working on this device for about 10 years. “More dialysis is better. I thought if we could miniaturize the big washing machines we use, we could implement more dialysis time,” he told NN&I. It is  designed to be worn as a belt and uses sorbent technology to offer continuous renal replacement therapy.

The device has already successfully dialyzed pigs and passed two human trials. The first U.S. trial will be conducted in Seattle in collaboration with Larry Kessler, MD, professor and chair of the Department of Health Services in the University of Washington School of Public Health, and Jonathan Himmelfarb, MD, director of the Kidney Research Institute, a collaboration between the University of Washington and Northwest Kidney Centers. “Seattle is the birthplace of chronic dialysis therapy. Long-term dialysis began here in Seattle; what better place to test the device?” Himmelfarb told NN&I.

Both Himmelfarb and Gura, though cautious, said they hope that the device can someday be worn by all ESRD patients. Gura said he hopes to create a world where ESRD patients are no longer tethered to dialysis machines and dietary restrictions.

“I am absolutely excited to begin clinical trials,” Gura said. “I’m like a kid in a candy shop.”

An implantable Renal Assist Device (iRAD) being developed by the University of California, San Francisco.
This device is being built and tested by 40 researchers in nine laboratories across the country under the guidance of Shuvo Roy, PhD, a bioengineer on the faculty of the UCSF School of Pharmacy. It aims to combine nano-scale engineering with advances in cellular biology to create an implantable device that would enable patients with chronic kidney failure to lead healthier and more productive lives, without external dialysis or immunosuppressant medication.
The UCSF artificial kidney, or implantable Renal Assist Device would include thousands of microscopic filters as well as a bioreactor to mimic the metabolic and water-balancing roles of a real kidney. “The new Pathway program is a clear signal to researchers that innovations in how we treat disease are needed and supported by the FDA,” said Mary Anne Koda-Kimble, PharmD, dean of the UCSF School of Pharmacy.

A Hemoaccess Valve System (HVS) designed by Greenville, S.C.-based CreatiVasc Medical.
In development by CreatiVasc, the Hemoaccess Valve System is designed to limit the flow of blood through the implanted AV graft to only when the patient is in dialysis. According to CreatiVasc, the system does the following:

  • Allows normal blood flow through the artery and vein at the AV graft site until dialysis is needed.
  • A valve can be activated in a variety of ways to open the flow of blood through the AV graft tube, allowing the patient access to the dialysis process. 
  • The valve system can then be flushed with saline and closed off when the dialysis session is completed, allowing for normal blood flow through the vein and artery.

“In an era where bundled payments for dialysis care has some believing that research and development may be stifled, this new ‘pathway’ may help to bring better technology to patients faster––and lead to improved quality of life.