Well, what we’ll discuss today is pretty amazing.

But, I need to explain a few things to you first, so you can see how amazing it really is.

Way back when- probably before many of you were born- back in late 1959, early 1960- I got intrigued by dialysis.  A process that could make it possible for folks whose kidneys had failed- due to disease, due to calamity or catastrophe- to continue living.   Back then, the system involved one of two sorts of devices.

 

 

 

Willem Kolff, MD, had pioneered dialysis using what was popularly called twin-coil dialyzers.  The best way to visualize this is to think of a washing machine.  And, around the central pedestal is a coil of membrane.  (I actually found a picture of one of the original devices Pim developed- along with the membrane coils to share here.)

 

The other device was a flat-plate unit.  Basically, it was a slab of grooved polypropylene with two membrane sheets and then another slab of the polypropylene.  Actually, the layer was often duplicated, so there were two blood-filled chambers and four saline filled chambers.  (I found a picture to share with you for this one, too.)

My work centered about the flat-plate unit.  I had not a clue (nor a whit of interest) in developing a new membrane.  My efforts were involved with the saline solutions and how to increase solute transport through and across the membrane, thereby cleansing the blood more efficiently and rapidly.

Back then the membranes were comprised of Cuprophane, a cellulosic material that wasn’t highly biocompatible, nor did it allow for rapid transport across the membrane.  But, my developments would work better if and when someone made a better membrane.

Cuprophane allowed small solutes – things like urea and creatinine- to transport across the membrane.  With time, other membranes improved the dialyzability of these compounds.  But, there are a bunch of other waste materials that kidney patients need removed- most of them are what are called middle molecules (which basically means they are bigger than urea and creatinine- but smaller than complex proteins)- and we don’t often know exactly what they are.

Over time, many membranes were developed.  And, now, transport of excess water from the blood is well-managed.  Which is why dialysis can now be completed in under four hours.  Back when I started, dialysis dragged on for 12 hours or more.  (My development knocked the time needed down to 6, which was a pretty dramatic improvement.)  But, those middle molecules still didn’t cross the membranes well.

But, membrane development has been pretty static for about two decades.  In the 1970’s, dialysis innovation centered on biochemical indicators- how well urea was removed from the body.  And, while new devices were introduced,  most of the developments in dialysis have been incremental.  Which means when someone thinks they have a “better idea”, the FDA (Food and Drug Administration) lets the inventor (or company) file a 501(k) application.  That application means that the device is very similar to what is already on the market and this is an incremental change.

Given that history, telling you that Baxter just got a de novo (completely new) medical device approval from the FDA should tell you that this is a completely different concept. And, it’s such a change that Baxter is calling the dialysis delivered with their invention “expanded hemodialysis therapy” (HDx).

What’s different?  This new membrane provides better capability to remove the middle molecules from the patients’ blood.  The difference between hemodialysis (HD) and HDx is simply using Baxter’s Theranova membrane in place of what was used before. In other words, this switch of membranes (with its enhanced middle molecule clearance) combines high permeability and selectivity for toxins that dialysis should remove from the body- but still retains the essential proteins (and albumin levels)within the patient’s blood.

Baxter claims this membrane more closely mimics the filtration afforded by natural kidneys- the ones that haven’t failed.  And, clinical data seems to support this.  Dr.  Daniel Warner (Tufts), along with Luke Falzon, Line Skoufos, Angelito Bernardo, Werner Beck, Mengqi Xiao and Ha Tran (all Baxter employees)  published test results in the Clinical Journal of the American Society of Nephrology.  

172 patients (mean age, 59, 61%, 40% Black)  on maintenance hemodialysis were randomized to receive treatment with either the Theranova 400 or a high-flux dialyzer.  (The dialyzers look identical on the outside- it’s the membrane within that makes the difference.) The monitored parameter for the study was the reduction ratio (removal capability) for lambda free light chains after 24 weeks of treatment.  Within 4 weeks, it was obvious that the removal was substantially improved using the Theranova units (39% v. 20% for high flux); the results remained similar after 24 weeks (33% v. 17%).  Moreover, the removal of complement factor D, TNF-alpha, and beta-2-microglobulin  (middle molecules, all) was improved with Theranova,when compared to high flux dialysis.

This is good news, indeed.

 

19 years ago, I traveled from New York City (after pigging out on Broadway and off-Broadway shows to celebrate my birthday) to National Airport.  The last shuttle flight.  Only to see a plane on my way to Rosslyn (VA) where it didn’t belong- heading East over Northern Virginia to hit the Pentagon.  That’s when I learned I took the last flight from LaGuardia and that  the World Trade Center had been the target for two planes hijacked by the deranged terrorists.  An attack on US soil- the first since Pearl Harbor.

Of course, we’ve been hit this year with a plague.  Compounded by one who is more interested in his own money and gains than the US citizenry.

We’ve survived the first attack.  May we successfully survive the newest terror reign- of the virus and TheDonald.