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| Illustration of an AV fistula--Courtesy of NIH |
Startup TVA Medical boasted about a recent study that found its clinical-stage device to give chronic kidney disease patients vascular access to a hemodialysis machine was successful 97% of the time.
The company's everlinQ System enables minimally invasive creation of a long-lasting arteriovenous fistula (AVF), or a connection between an artery and a vein. Normally, blood flows from arteries to veins via the capillaries, but using an AVF, the capillaries are bypassed, explains the Mayo Clinic.
Naturally occurring AVFs require medical treatment, but they are also surgically created in the forearm prior to dialysis because there is no natural blood vessel near the skin that can handle the rapid flow of blood into and out of the body performed by a hemodialysis machine.
However, sewing together an artery and a vein, as is typically done, only works about half of the time, requiring repeat procedures and causing scarring. In addition, the AVFs that don't collapse often require reintervention in order to maintain the new blood vessel.
The everlinQ consists of two catheters that are inserted into the arm, and align magnetically inside the body. Then an electrode creates a hole in the artery and the vein using radiofrequency, creating a new blood vessel. Finally, the catheters are removed, and blood starts flowing directly into the vein. Once more blood begins to flow into the vein, it enlarges, allowing a nurse to enable hemodialysis with a needle, explains the Houston Chronicle in a recent profile of TVA Medical.
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| TVA's Billy Cohn |
In addition to the high success rate, the 33-patient study in the Journal of Vascular and Interventional Radiology found that 96% of the everlinQ patients had a functional AVF at 6 months; on average the AVFs enabled hemodialysis for 58 days.
"I look at this technology kind of like the Phillips screwdriver," TVA co-founder and device inventor Dr. Billy Cohn told the Houston Chronicle. "It didn't make the regular screwdriver obsolete, but it was a great advance with great advantages. If this device allows patients to get a fistula that lasts longer and allows them to access dialysis earlier, that will be an option that should be available in a lot of hospitals."
The everlinQ has a CE mark for use in Europe and is being studied in Germany, Canada, Australia and New Zealand. Cohn told the Chronicle he hopes to begin U.S. clinical trials of the device for FDA approval in 2016.
- read the release
- here's the study abstract
- here's the article in the Houston Chronicle
- get more about arteriovenous fistulas from the Mayo Clinic