Huasen been diddling on his "micro utter" for years but it just won't produce milk. It's a long boring story without a climax. He just keeps milking it.
the problem with this is if they get an indication range for vascular that has a lower limit in thickness range that cannot be crossed by surgeon (it is tough to get an exact tissue thickness measurement while firing lap) then they will never have the freedom to let the product launch widespread until the issue is resolved and as such this approval if attained adds no value in terms of sales......at least until the issue is corrected. Then after corrected they can sell without risk or reduced risk of deployment outside approved indication.....but that IFU will have a narrow indication relative to competitors (as a small gun 30mm x 5mm they need vasc all the way down as low as possible) and that could inhibit sales by customers who stick to indication ranges (so called smart surgeons) so they would then need to resubmit to expand the approved indicated range for marketing purposes. Or they could say well we are indicated for x but you can safely go x - y typically this is the case for the market however on the thicker end of the limit
May 6th conf call did not mention continued bleeding on the contrary Hausen implied it was corrected. Limited launch can be caused by several things.... If they are applying for vascular indication they will only get indication for that which is supported by data. Submitting data on vascular deployments that were hand picked rather than all clinical outcomes will only get them a very limited indication.....if you are saying they will get full vascular indication based on selective results then are you implying they are submitting only data that supports their request to FDA? and to control their own risk they will use selective surgeons who will quietly stay within the real secret indicated range because the actual approved (if approved) indicated range is not valid? I'm not sure what are you implying here?
where did you get this level of detail? They did not express this level of detail on the call or in PR. It seems a bit too concise to be pure conjecture. However it is par for the course with these guys....we have been saying we will modify this thing for 3 years but yep still doesn't work and we still need to modify....as I said before at any other company heads would roll with this kind of lack of execution. Broadfin didn't change a thing just got in the way.
They just submitted for "vascular indication" so if the bleeding isn't solved they wont get approval and they would not continue to use it in EU . Vascular is a subset of "white" it is the low end.
Listened to the call. I didn't expect too much as it takes quite a bit of time to make these changes. The call was pretty tame it was difficult to stay interested but Kotler asked a very detailed question. That question is not something he would know to ask unless he has been doing research or was prompted to ask it by a third party. I'm speculating more to the latter because he asked it incorrectly and was content with Bernard's answer which should have prompted a second question because it revealed a very distinct difference in their design. Don't let the naysayers persuade you that they don't have something good here they just need to draft the right team of folks to execute. Keep in mone this stuff is not high tech and in fact could be executed by moderately capable manufacturing houses. The design is clever yes and it is coveted. I would venture to speculate the big boys are just hoping cardiac fails at execution and by historical standards they have good odds it should happen The reason med device innovation lags mainstream innovation is because it's a closed market of a dominant few How many smart people out there ever see a surgeon work? See his challenges and difficulties? The select few geniuses and many idiots at the top firms get a first hand view but I would argue even they don't see it enough.
This 510K for vasc will not be as involved as previous (no clinical trial) and the redesign for blue could possibly just be a letter...to notify