There’s a new program at the US Food and Drug Administration. One designed to afford innovative devices a speedier review process. This Innovation Pathway 2.0 program is designed for pre-market evaluations of medical devices, expediting the process without reducing the need or quality of safety and effectiveness reviews. And some 30 years ago, there was a similar process for smaller companies- it worked, then, too. (I know, we used it- twice!)
Right now, there are three products/technologies undergoing this new process. The process involves more open and close relations between the FDA and the device developers, to identify and solve scientific and regulatory issues, providing a clear roadmap to acquire product approval.
This new pilot program is aimed at the devices developed to treat ESRD (End Stage Renal Disease) – also known as chronic renal failure. The approval process will spread to other medical conditions, as the wrinkles are ironed out.
One of the 3 products undergoing this process is one reported here about two years ago. Dr. Shuvo Roy, who is now at the University of California, San Francisco, is still leading the effort. His implantable (in the gut) dialysis device (containing viable, live kidney cells) is expected to begin clinical trials by 2017.
The second device was developed by Dr. Victor Gura (UCLA), and licensed to Blood Purification Technologies, Inc. (Beverly Hills, CA). It is a wearable artificial kidney (ok, it’s currently 10 pounds), battery powered, contained in a belt around one’s waist. It is about to undergo clinical trials at the University of Washington (Seattle) and the Northwest Kidney Centers, withDrs. Kessler and Himmelfarb heading the effort.
The third device is a blood access device (Hemoaccess Valve System) invented by CreatiVasc Medical, Inc. (Greenville, SC). The device aims to replace the fistulae, arteriovenous grafts, and catheters that are used to afford an extracorporeal connection to the dialysis devices. It is one of the first new developments in this area in 30 years. The device actually turns the flow off to the graft when dialysis is not occurring, which reduces the risk of clotting, infections, and other complications.
Knowing how well this worked for us, we can only hope this Pathway keeps its doors opened- and opened to a variety of medical devices.
WOW How cool is that, and the implications of it…well I could see something like this in the future for diabetics with insulin production! I don’t think the general population realizes how hard dialysis is. I became great friends with a Nurse who was in charge of (under the doctors) chemotherapy clinical trials. She was one of my favorite people in the world, just wonderful. At the end of our first round of chemo/phase1 she told me that she was moving to dialysis. A year later when we returned to Taussig we found that she had come back to the cancer center. I pulled her aside and asked her why…she didn’t go into details, at least ones I can share, but the bottom line for her was that dialysis was more heart breaking than the chemo center. So a break through like this, is going to revolutionize treatment.
PS. I’m proud of you for breaking your soda habit 😉 The world needs you and people like you in it, so you have to take as good a care of yourself as possible. The world would be much less without you. <3
I recall the dialysis centers of old (pre-Federal funding) and those overseas well, Lisa. When treatments ran 6 to 12 hours thrice a week- that was a burden.
What most people do not realize (cognitively) is that, although dialysis is a “normal” practice, the effort removes the patients blood from his/her body 20 to 20 times an hour for three to four hours. And, this is effected in an outpatient setting, with one nurse for every 5-8 patients, and maybe 1 doc for every 50….
Just gives one pause for thought…
Roy
Wow, this is incredible news. I am so glad I found your blog. I learn something new every single day. Off to share as this is the kind of news one does not keep to themselves!
Kathie Hitt recently posted..Have You Identified Your Heroes?
Kathie-
I’m glad you found my blog, too! Thanks for your kind comments…
Roy
Thanks for the update. I am so thankful for people & companies who keeps innovating and improving our medical situations.
shawn recently posted..Outside Activities and Your Kids
Me, too, Shawn!
I like it even better when we are one of those companies 🙂
Roy
Dialysis equipment today is required to have a system that protects patients from blood loss in the event of venous needle dislodgement. The commonly accepted solution is to monitor by the venous pressure alarm, but a better solution has long been required. Even with the routine supervision of medical staff, the venous needle can still become dislodged.
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That is, indeed, true, Mike.
Do you have such an idea?