FDA fast-tracks three new technology products

FDA announces plans to pilot end-stage kidney disease technology in new program

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.

The ESRD products will be the focus of the second version of the Innovation Pathway, first announced in 2011, to shorten the time and cost it takes for the development, assessment and review of medical devices, in particular breakthrough medical devices.

ESRD is the progressive loss in kidney function over a period of months or years. The kidneys play an essential role, filtering and removing waste from the body and producing hormones that are responsible for calcium absorption and red blood cell production.

The FDA chose ESRD because more than half a million Americans suffer from the disease. Management of the disease is largely dependent upon medical device technology, such as hemodialysis (process for removing waste products) equipment.

This info is from a recent press release by the FDA

Transplant Waiting Lists In Australia

In Australia the percentage of dialysis patients over 65 who are on a waiting list for a transplant is surprisingly low compared to many other countries. In the UK it is 48%, in France it's 49% and in the US its 33%. But in Australia it's just 18%. The numbers are slowly falling as well, despite an increase in the numbers having dialysis. Yet patients receiving a transplant have a longer survival rate than those on dialysis. An article on the Australian site 9News reports on this problem.

The reasons for this low rate aren't totally clear - are local doctors making a decision based on limited information? Under the current law a person must have an 80 per cent chance of surviving at least five years after a transplant to be considered. Is the survival chance being estimated wrongly and suitable patients ignored?

In the Northern Territory, the rate is unusually low - reported as being just 1% (!) by ABC.net.au just yesterday. And they say that one renal health worker in the Northern Territory says the situation amounts to institutionalised racism. Note that Indigenous Australians make up 32.5% of the population of the area (according to Wikipedia), and have reportedly had poor health treatment in many news reports over the years. So perhaps this is what the ABC.net news item is referring to. But whatever the cause, 1% being on a transplant waiting list is an extremely low figured compared to other countries!

Oil Services company decides to support Scottish dialysis charity

Aker Solutions is an international oil services company with a base in Aberdeen, Scotland. They have just announced that they will support two charities during 2012, one of which is the Kidney Dialysis Unit Stonehaven. The charity was brought to their attention when one of their IT support staff was diagnosed as suffering from chronic kidney disease. Since then the staff member, Julie Robertson, has been involved in several fund raising events, and is overwhelmed by the support her employer has given, culminating in this charity sponsorship.

Does your company have a charity policy? Do they they choose a different charity each year? Why not drop the hint about chronic kidney disease and dialysis units? Many of the bigger companies are quite happy to support charities in their local area (and not for the publicity it brings them either). Most will look at several and then, like Aker Solutions, make a decision on a couple to support for a year, then review things the next year, to spread their contributions around a bit, while providing a great deal of help to the chosen ones during their year or so of support. Staff members in situations like Ms Robertson often create a stir with their own work and trigger the company into action. Go on, try it yourself.