I received a lot of good feedback on my post regarding the Flair Stent Graft from BARD-Peripheral. I believe that it represents the new standard of management for dialysis access management when angioplasty has failed due to recoil, continued pressure gradient and obviously, dialysis vein ruptures. In my opinion, we now have a device which is not off-label for the dialysis access indication, it has randomized data to compare it to angioplasty. Favorable randomized data comparing angioplasty to bare stent technology is absent. The only unknown at present is pricing. It will be interesting to see the price point that BARD peripheral selects. It has to be priced comparably to the FLUENCY covered stent. Or I think that people may attempt to extrapolate the data and results to the FLUENCY device and use that instead.
The device is currently in a response phase in the FDA approval process which suggests that it could be approved anyday. Well informed resources suggest that BARD Peripheral would be surprised if they are not approved and selling the device by September 2008.
In other news: Angidynamics has voluntarily recalled it centros catheter. Apparently the catheter cuff was inadequately attached in some instances...Source
oh so funny!
Posted by: air max 90 | November 11, 2010 at 10:43 PM