Receiving the Watchman FLX - impressions and experience August 04, 2018 01:52PM |
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Re: Receiving the Watchman FLX - impressions and experience August 04, 2018 02:21PM |
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Re: Receiving the Watchman FLX - impressions and experience August 04, 2018 08:54PM |
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Re: Receiving the Watchman FLX - impressions and experience August 05, 2018 12:39AM |
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Re: Receiving the Watchman FLX - impressions and experience August 05, 2018 12:49AM |
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Re: Receiving the Watchman FLX - impressions and experience August 05, 2018 01:31AM |
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Carey
Thanks to all who participated. Who pays, Boston Scientific?
Yes. They only reimburse $80 per trip for travel, but they pay for everything else.
Re: Receiving the Watchman FLX - impressions and experience August 05, 2018 08:33AM |
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jpeters
"The 2-year suspension of the medical device tax by U.S. House and Senate, starting January 2018, has also provided temporary relief to the company, allowing it to make resources available for its future R&D programs."
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Re: Receiving the Watchman FLX - impressions and experience August 05, 2018 11:37AM |
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Re: Receiving the Watchman FLX - impressions and experience August 05, 2018 06:38PM |
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ln108
Hmmm. Now that Liz mentions it, I'm clear that Natale and colleagues recommend the Watchman FLX whole heartedly and without reservation. However, what I'm not clear on is whether it is fully FDA approved and covered by insurance outside of trials such as this one at Austin that a number of this group has been fortunate to participate in.
Re: Receiving the Watchman FLX - impressions and experience August 05, 2018 10:03PM |
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Re: Receiving the Watchman FLX - impressions and experience August 06, 2018 12:10AM |
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rocketritch
I thought the reason for the second trial of this device was because the original study was heavily weighted on the female persuation. And that this trial would be mostly or entirely men.
So far as it being done in several different locations would be due to random data collection required by the FDA and or including the European equivalent (EMA) .
I'm not sure as to how many implantations would be required for a second trial, but it could be in the hundreds.
Re: Receiving the Watchman FLX - impressions and experience August 06, 2018 01:46AM |
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Carey
Your understanding is correct. This trial is only open to men because previous trials were too heavily weighted with women. It's being offered in 10 centers with a total of 490 devices available for the trial.
Re: Receiving the Watchman FLX - impressions and experience August 06, 2018 12:19PM |
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jpeters
It's not hard to see why the BSX is trading at a PE of 413.95 and EPS of .08. Success amounts to hoping that the latest round of tests shows much lower embolization rate than before the recall, approval by the FDA, and then acceptance by the insurance industry....and if they need to change anything, repeat.... Think I'll stick with consumer staples.
Re: Receiving the Watchman FLX - impressions and experience August 06, 2018 12:38PM |
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rocketritch
The medical implant industry is very volatile. I'm not sure what the percentage of devices that make it to med trial evaluation to those that get tanked before they even get there is but I would wager the difference is in the range of 80/20 in favor of those getting tanked
Its a tough industry at best
Re: Receiving the Watchman FLX - impressions and experience August 06, 2018 02:06PM |
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jpeters
And then some unknown comes up after they're approved, requiring a recall, and the process starts all over again. They need to be subsidized, not taxed.
Re: Receiving the Watchman FLX - impressions and experience August 07, 2018 09:07AM |
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Re: Receiving the Watchman FLX - impressions and experience August 07, 2018 10:47AM |
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Re: Receiving the Watchman FLX - impressions and experience August 07, 2018 02:19PM |
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Re: Receiving the Watchman FLX - impressions and experience August 07, 2018 05:25PM |
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smackman
I have never heard about this free trial by Boston Scientific until now. I have had 2 Ablations with Dr. Natale, The last in June 2016. I am on a blood thinner for life and hate it.
How did you individuals find out about this? You must know someone.
Re: Receiving the Watchman FLX - impressions and experience August 09, 2018 06:19PM |
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Re: Receiving the Watchman FLX - impressions and experience September 11, 2018 02:50PM |
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Re: Receiving the Watchman FLX - impressions and experience September 12, 2018 12:35AM |
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Re: Receiving the Watchman FLX - impressions and experience September 13, 2018 02:03PM |
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AB Page
I had my 45 day...ok technically 40 day follow-up TEE this morning and the imaging showed it to be anchored properly and no leaks. Great news!
I will start clopidogrel and stop Eliquis when I return home, as well as continue the low dose aspirin. Dr. Natale seems to believe that Eliquis would be the better choice, but this is a study, so I will make the switch, until the six month mark in very early February, when the next follow-up will be. They weren’t certain if another TEE is required, but even if not, I think I would still like to have one as I am pretty conservative. Still can’t say enough good things about all the folks at St. David’s and TCAI. A big thanks to Shannon as well!
I asked Dr. Natale about early data and what they are seeing, and he said it looks really, really good so far, in fact no device related thrombus (thrombi?). Not sure if that is just St. David’s or for every participating site.