FDA Innovation Pathway 2.0 Begins with Kidneys
Three products, that include a wearable artificial kidney, have been chosen to participate in the FDA’s Innovation Pathway 2.0.
These products have been selected from a pool of 32 applications ranging from an artificial kidney to devices that assist kidney function. The submissions came after the FDA launched a system designed to help quicken the process of taking medical technology to the patients.
The products, called in for a review by FDA, were for patients with end stage renal disease (ESRD) - a chronic kidney failure that affects nearly 2 million people worldwide.
US has about 570 000 patients with end-stage renal disease. The cost of treatment reaches almost $40 billion each year. Kidney transplantation which is the most effective treatment in this case is almost impossible with its high cost and the shortage of kidneys available for transplant. The procedure comes with an additional risk of the body rejecting a new organ.
According to Organ Procurement and Transplant Network, in 2011 only 16,821 kidneys were available for transplant. This means that 92,000 patients were on ‘waiting-list’ that year.
FDA‘s approval of innovative devices that replicate the function of kidneys could potentially lead to improving lives of thousands of patients who suffer from economic burden of treatments like dialysis.
Medicare alone covers some 75% of ESRD health care costs, which in 2009 jumped to $ 29 billion.
“The response from the innovators exceeded our expectations and demonstrates that there is a desire from developers of innovative technologies for earlier and more collaborative agency interaction.” Said Jeffrey Shuren, M.D., Director of the Centre for Devices and Radiological Health (CDRH)
The program hopes to build ties with innovators and speed- up the process of bringing new medical devices. FDA has been criticized in the past for not doing enough in encouraging new technologies.
Interestingly, a majority of the 32 applications received for this program came from small businesses or academic institutions.
One of the products chosen by the FDA for review is the ‘Implantable Renal Assist Device’ that is being developed at the University of California. Shuvo Roy, PhD, bioengineer at the University, says that this device brings nanotechnology and knowledge of cellular biology to help patients avoid immune suppressant medication or external dialysis. It is reported that this device would include thousands of microscopic filters as well as bioreactor to mimic the metabolic and water- balancing roles of real kidney. The developers are hopeful that FDA’s program would help the project get enough grants (approx $ 20 million).
