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Monday, December 06, 2010 10:22:05 AM
"Preliminary clinical data suggests that the Levacor VAD does not cause acquired von Willebrand Factor (vWF) deficiency, a condition that is linked to serious bleeding disorders(1) and that has been associated with the use of current VADs"
Although not directly compared to HTWR's device, I think it is important to note that it was recently reported that the incidence of stroke in the HTWR device "was higher than might have been expected with the smaller size of the device, both Aaronson & Yacoub said, and this is something that will require watching. "The trial is only 180 days: we await the longer-term results with extreme interest because if there is major advantage it's going to be seen later. We need to be really critical and look at the results as we go along and not just say 'Hurrah,' " says Yacoub. There are other issues, too, he added, "such as evidence of GI bleeding due to malformations in the gut, and they got that already by 180 days. Also you get changes in the blood itself, the von Willebrand factor, and that is because of the lack of pulsatility. But that doesn't prevent me from concluding that this is a landmark trial and this device is extremely promising."
So it appears that for those who have already declared HTWR the "winner", the race may not be over. Personally, I'm of the opinion that this is not a winner take all scenario and there will be a role for THOR, HTWR and WHRT in this market.
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