Watchman FLX Recommended by Natale

Friends,

I spoke to Dr. Natale yesterday here in San Diego about getting a Watchman device. He wants me to wait a month until the Watchman FLX is available here. The FLX seems to be a new, "second generation" version of the device. I was wondering if any among this distinguished group knows anything about this new version. Should I be concerned that it seems relatively newly available, and therefore, perhaps, untested?

I did some googling, and it seems that this new version has been available in Europe since 2015, but--somewhat worryingly--was withdrawn in the EU after Boston Scientific, the manufacturer, "receiving reports of device embolization," including one person dying from complications of "an infection suffered after the device was retrieved."

I'm not able to find anything on the further history, approval in the US, etc. I'd appreciate feedback from this group.

Obviously, having had two ablations from Dr. Natale, I'm aware that he wouldn't recommend it unless he was confident. Still, I'd like to know the full picture.

Thanks!

--Lance

The patients in the original clinical trials in the US were disproportionately female, so the FDA asked Boston Scientific to repeat the trial with men. I was approved for that trial, so next week I'll be in Austin to have a FLX implanted. I spoke with Drs. Natale and Rodney Horton at HRS2018 and they both enthusiastically endorsed the FLX. In Dr. Horton's words, he wouldn't hesitate to recommend it to his own friends and family members, and he's probably implanted more of them than anyone in the US. It's a better design in a number of ways and is easier to implant. Boston Scientific also addressed the device embolizations with several design changes. If you haven't already seen it, have a look at this article, and in particular the "Limitations" section, which describes the design changes they made. I also attended a webinar by Dr. Christopher Ellis of Vanderbilt who has extensive experience with left atrial appendage occlusion devices and he was equally enthusiastic about it.

I'm not in the least bit concerned about the device or the procedure. You don't get enthusiastic approval from people like Natale, Horton and Ellis when there are doubts or limitations.

Thanks, Cary. To the point and extremely helpful, as usual.

--Lance

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Carey
The patients in the original clinical trials in the US were disproportionately female, so the FDA asked Boston Scientific to repeat the trial with men. I was approved for that trial, so next week I'll be in Austin to have a FLX implanted. I spoke with Drs. Natale and Rodney Horton at HRS2018 and they both enthusiastically endorsed the FLX. In Dr. Horton's words, he wouldn't hesitate to recommend it to his own friends and family members, and he's probably implanted more of them than anyone in the US. It's a better design in a number of ways and is easier to implant. Boston Scientific also addressed the device embolizations with several design changes. If you haven't already seen it, have a look at this article, and in particular the "Limitations" section, which describes the design changes they made. I also attended a webinar by Dr. Christopher Ellis of Vanderbilt who has extensive experience with left atrial appendage occlusion devices and he was equally enthusiastic about it.

I'm not in the least bit concerned about the device or the procedure. You don't get enthusiastic approval from people like Natale, Horton and Ellis when there are doubts or limitations.

Congratulations on being accepted into the trial. I brought up the Watchman to Dr Natale following my ablation last week. He said it was too soon and that we would discuss it when I am back in January.

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rocketritch
I brought up the Watchman to Dr Natale following my ablation last week. He said it was too soon and that we would discuss it when I am back in January.

Yeah, if your LAA was isolated during the ablation then you're going to need to do a TEE at six months to check the flow velocity in your LAA and a few other parameters. If flow velocity is high enough and the other criteria are met, you can stop anticoagulants or drop down to a half dose. So it would be premature to do a Watchman now since you might not end up even needing one. And if you don't meet the criteria for stopping ACs, my understanding is he wants his patients to wait about a year before doing a Watchman. He wants to make sure you're afib is fully in remission and a touch up won't be needed before doing the Watchman.

That’s basically what he said.

It’s interesting to me that you were chosen to be part of then Clinical study. I was in the medical device field for several years. Did allot of R & D design work and manufacturing and was managing a project that was headed to clinical trials just before I left.

Hello Carey, I will also be at TCAI/St. David's next week for my Watchman FLX procedure on Thursday. My wife and I will arrive in Austin Tuesday afternoon and I have an Appt. with Dr. Natale at 12:00 on Wednesday followed by an echo and a CT in the afternoon. We feel as you do, that we are in the most capable and caring hands. After two Natale ablations, we are not anxious in the least and looking forward to getting that LAA occluded. Best wishes to you for safe travel to Austin and another excellent experience there.

Jerry and Deb Smith

Now we know who has the time slot after Carey and before me. I’ll be the dude with grey hair in the waiting room, or perhaps in the examining room next to you. I’m getting the Watchman Thursday also.

Andy

Well Andy you won't be the only gray haired dude, lol. I will be the gray haired dude next door. I will be watching for you and Carey and maybe we'll have a chance to say hello. Hope you have a safe and pleasant journey to Austin.

Jerry

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jsmith1015
Well Andy you won't be the only gray haired dude, lol. I will be the gray haired dude next door. I will be watching for you and Carey and maybe we'll have a chance to say hello. Hope you have a safe and pleasant journey to Austin.

Jerry

Very cool Jerry. Safe travels for you and your wife as well. Hopefully we’ll all have the chance to say hello, if not after our consults, then on the wing Thursday or Friday.

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jsmith1015
Hello Carey, I will also be at TCAI/St. David's next week for my Watchman FLX procedure on Thursday. My wife and I will arrive in Austin Tuesday afternoon and I have an Appt. with Dr. Natale at 12:00 on Wednesday followed by an echo and a CT in the afternoon.

Well, quite the party we've got going!

But are you sure about the 12:00 pm Wednesday appointment with Natale? Because if you are we've got a bit a problem. That's also my appointment time with him.

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Carey

Hello Carey, I will also be at TCAI/St. David's next week for my Watchman FLX procedure on Thursday. My wife and I will arrive in Austin Tuesday afternoon and I have an Appt. with Dr. Natale at 12:00 on Wednesday followed by an echo and a CT in the afternoon.

Well, quite the party we've got going!

But are you sure about the 12:00 pm Wednesday appointment with Natale? Because if you are we've got a bit a problem. That's also my appointment time with him.

Bring a good book

Well Carey, we both have an appt. for 12:00. Things usually go pretty smoothly at TCAI so I just go with the flow. I recall someone mentioning that Dr. Natale would be doing ablations that day so I'll bet he will see us between ablations. See you Wednesday. Jerry

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jpeters


Hello Carey, I will also be at TCAI/St. David's next week for my Watchman FLX procedure on Thursday. My wife and I will arrive in Austin Tuesday afternoon and I have an Appt. with Dr. Natale at 12:00 on Wednesday followed by an echo and a CT in the afternoon.

Well, quite the party we've got going!

But are you sure about the 12:00 pm Wednesday appointment with Natale? Because if you are we've got a bit a problem. That's also my appointment time with him.

Bring a good book

Since I’m after both of you, I’ll be sure to have my Kindle. Or we could just all 3 meet together!

Perhaps Dr Natale is going to meet with all of you at the same time so that he does not have to repeat himself. -

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JakeL
Perhaps Dr Natale is going to meet with all of you at the same time so that he does not have to repeat himself. -

There's probably a lot of truth in that.

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JakeL
Perhaps Dr Natale is going to meet with all of you at the same time so that he does not have to repeat himself. -

I would be ok with that. I’m not sure that any of us have questions that are not appropriate for the others, and maybe one of us has a question the other hasn’t thought of. I suspect HIPAA laws would prevent this. I certainly don’t mind my medical history being discussed among others in the same boat. I can certainly understand the need or desire for privacy too. I’m generally a very private person, but for this it’s unique and different.

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jsmith1015
See you Wednesday. Jerry

Apparently so! I find this rather amusing.

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Carey

See you Wednesday. Jerry

Apparently so! I find this rather amusing.

You'll be able to explore this and other feelings with your group on Wednesday

Anyone has experience with a Watchman already placed?