Watchman FLX Implant Report

Dear Friends,

I arrived home Friday afternoon after Watchman FLX procedure at Scripps La Jolla on Thursday. Dr. Douglas Gibson did the deed; Dr. Natale was superintending as my EP. It was pretty straightforward. The only hiccup was that there was some confusion--based on a report from the TEE I had a week ago--as to whether my LAA might be too small for the new Watchman FLX. So when I went in yesterday morning for the procedure, I was expecting to get the old Watchman. But Dr. Natale, Dr. Gibson, and Dr. Natale's NP had meanwhile huddled and reinterpreted the TEE images, and they said it looked like I was good to go with the smallest FLX device, which they in fact confirmed with the TEE that was part of the procedure itself. That's the way it turned out. I got the FLX, remained in the study, and all is thus far well. I guess the Dr. that initially read the original TEE got the measurements wrong.

So there's a single puncture scar in my groin, which seems to be healing nicely. So far, no bleeding, bruising, or hematoma. Through Friday, my head was still fuzzy, I think from the anesthesia, but otherwise I'm feeling pretty good, and as of now planning to go in for a light day at work on Monday.

Warm regards,

Lance

--Lance

Great news, Lance! Welcome to the club. :-)

Thanks, Carey. I appreciate your support, and your earlier reports!

--Lance

Good news, Lance. Thanks for sharing.
Now..... Onward!
Jackie

When will the Watchman FLX study be completed....and is it available for people not in the study....with EPs who have experience with it? Just wondering what the status is now. I may have the Watchman in my future.

Also....want to say that my User name in this forum was not meant to imply that I am part of the "Just Me Too movement". I chose it to mean that "Just me too has A-FIB" !

Thanks and good wises to all.

The clinical trial is scheduled to end June 2021. My understanding is they've already stopped accepting new patients into the trial, so it wouldn't surprise me if it was sooner than that. The purpose of the trial is to obtain FDA approval of the device, so that means it hasn't been approved yet so no, you wouldn't be able to get the device in the US without being in the trial. It is available in Europe, however, if you're feeling like a vacation.

Glad everything went well for you

Good job Lance!

What’s the difference between The Watchman and Thhe Watchman FLX? Thank you, Louise

Louise,

I'm not an expert, but the Watchman FLX is a new redesign of the older Watchman, generally referred to as "next-generation." It has a closed design, not like the open "umbrella" configuration of the older Watchman. It also has eliminated, or at least covered. the small top "bump" that was a structural element of the original device, and it has more hooks on the side to hold it in place.

The main advantage of the new design, I was told, is that it can be "recaptured" and repositioned during the intial insertion, so that the operator can seat it properly if it's not correctly positioned on the first try, without, as is currently the case, having to withdraw it completely and start again. Also, the lack of a bump at the top is supposed to minimize the chances of a device-related thrombus forming during the period when the device is not completely endothelialized (covered over with heart tissue).

The FLX is not yet approved by the FDA, and so is not generally available. A few members of this forum, including myself, received Watchman FLX devices as part of a study. See this thread on this forum.

There's not much information online yet about this new Watchman, perhaps because it's not yet FDA approved. But see:

Watchman FLX in Clinical Trial

Boston Scientific Receives CE Mark For Next-generation Watchman FLX LAA Closure Device

--Lance



Edited 1 time(s). Last edit at 01/08/2019 02:23AM by ln108.

Thank you, Lance. I wonder if I should wait for the new one...