Sunday, April 22, 2012

New Devices for Dialysis Patients

Treating patients with End Stage Renal Disease or chronic kidney failure costs the nation almost $40 billion each year for treatment. The most effective treatment is kidney transplantation but those organs are in short supply and last year only 16,000 kidneys were available for transplant leaving many patients on the waiting list, according to the Organ Procurement and Transplant Network. 

Researchers at the University of California at San Francisco are developing an implantable artificial kidney for dialysis patients. The research project has been selected as one of the first research projects to undergo more timely and collaborative review at FDA.  The research at UC San Francisco combines nano-scale engineering with the most recent advances in cellular biology to create an implantable Renal Assist Device (iRAD).

Shuvo Roy, PhD, leading the artificial kidney research at the university has met with possible investors and granting agencies seeking funds expected to be $20 million for artificial kidney clinical trials that are targeted for 2017.

To help researchers and companies cope with regulatory hurdles, FDA launched the “Innovation Pathway” program, a pilot program to address innovative device development for ESRD. FDA selected ESRD as a topic because management of the disease is largely dependent upon medical device technology including hemodialysis equipment.

To begin the selection of research projects, on April 9th, FDA chose the UC San Francisco product and two other products from 32 product applications that were submitted ranging from an artificial kidney to devices that assist kidney function. The majority of the 32 applications came from small, start-up businesses, or academic institutions.

To be selected, the product had to involve an innovative technology, use a novel approach to solve a technological problem, and very importantly, further FDA’s in-house technical/clinical expertise.

FDA’s subject matter experts, management, and members of the innovation subcommittee of the Center Science Council discussed each application internally, held an initial teleconference with each candidate to better understand the device technology, the impact on public health, the possible regulatory impact, and the product’s stage of development.

Blood Purification Technologies Inc. (BPTI) in Beverly Hills also selected has developed a Wearable Artificial Kidney (WAK). The company has exclusive worldwide rights to the technology and plans to move quickly to commercialize it. BPTI seeks to raise $20 million to complete product development and design, testing, and final approval. 

The third product selected was the Hemoaccess Valve System (HVS) designed by CreatiVasc Medical located in Greenville, South Carolina. HVS has undergone extensive testing and FDA has approved CreatiVasc’s system for human clinical trials which are now underway.

Applicants from the ESRD Innovation Challenge are now going to participate in FDA’s Center for Devices and Radiological Health (CDRH) “Innovation Pathway 2.0” program set to deepen the collaboration between FDA and innovators earlier in the process prior to pre-market submission. The program will also serves as a living laboratory to test new tools and methods for breakthrough devices that may also be applied to other technologies.