By Peter Laird, MD
The first projects of the new FDA Innovation Pathway went into effect today with the announcement of three pilot programs for ESRD.
Innovation Pathway aims to reduce time and cost of bringing safe and effective, breakthrough technologies to patients
Three products for patients with end stage renal disease (ESRD) have been chosen to participate in the FDA’s Innovation Pathway, an evolving system designed to help medical devices reach patients in a safe, timely and collaborative manner.
The FDA selected three from 32 product applications ranging from an artificial kidney to devices that assist kidney function that were submitted in response to a January 2012 request from FDA’s device center.
The three products are:
- An implantable Renal Assist Device (iRAD) being developed by the University of California, San Francisco.
- A Wearable Artificial Kidney (WAK) in development by Blood Purification Technologies Inc. of Beverly Hills, Calif.
- A Hemoaccess Valve System (HVS) that has been designed by Greenville, S.C.-based CreatiVasc Medical.
The majority of the 32 applications came from small, start-up business or academic institutions.
Dr. Victor Gura invented the Wearable Artificial Kidney (WAK) and has already successfully tested this device prototype in Italy and London. (here and here) With 168 hours of total dialysis per week, it achieved creatinine clearances of 40 ml/min. The importance of a creatinine clearance this high is this is the level that is predicted to allow children with ESRD to grow normally, which was one of Dr. Gura's goals in developing this device.
The FDA Innovation Pathway is a welcome addition to the renal community and adds a new layer of market place developments that will push the entire industry to a new level never seen before. With current weekly Kt/V goals of 2.0, this device will push the limits to over 7.0, equivalent and at times exceeding the creatinine clearances of patients with renal transplants. I look forward to the brave new world of renal disease medical devices now coming to the forefront of renal replacement technology that has stagnated for several decades.
The FDA Innovation Pathway promises reduce the death and suffering associated with the standard in-center treatments. The large dialysis organizations (LDO's) will need to reply in kind as renal replacement therapies now enters a new generation of device innovations. The promise of living independently and unshackled from the burdens of renal disease may soon become the standard treatments for those unfortunate to have irreversible loss of renal function. The news from Washington D.C. today begins a new era of dialysis therapies that the renal community shall surely welcome.