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In the heart, there is a small sac like structure called the left atrial appendage. This can put patients in atrial fibrillation at a higher risk for stroke due to blood pooling in the appendage.

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This device works by sitting in the left atrial appendage to prevent blood clots from forming. After sitting in the atrial appendage, the device can allow the appendage to epithelialize and close up completely. It has been successfully placed in over 300,000 patients.

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The new and improved device was FDA approved in July of 2020.

The original device was created a few years prior, but many improvements such as different sizes so that it would be effective on all atrial appendages. One big update they made to the watchman was putting a polymer coating which "provided an 86% reduction in inflammation 3 days following the procedure (American College of Cardiology, 2023)."

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Boston Scientific's WATCHMAN, a device that's used to close the left atrial appendage, has done wonders for preventing the formation of clots that lead to stroke in many patients. Now the company has announced that its WATCHMAN FLX, a new and much improved version of the implant, won FDA approval. Already cleared in the European Union, the WATCHMAN FLX is indicated for patients with non-valvular atrial fibrillation (NVAF) for whom oral anticoagulants are not sufficient.

The new minimally invasive implant can be recaptured, repositioned, and redeployed until proper placement is achieved, or removed if the procedure proves too challenging. A new frame helps to achieve a better seal with the tissue, thereby reducing the chance of blood coming in or out of the left atrial appendage and producing a thrombus. Overall, the fully rounded design helps to navigate the implant into place and five different sizes allow for a precise fit, as well as for a wider array of patients to be treated.

"We've been very pleased with the real-world clinical outcomes and positive physician feedback for the WATCHMAN FLX device in Europe and are excited to extend availability of this next-generation technology to patients and clinicians throughout the U.S.," said Joe Fitzgerald, president, Interventional Cardiology, Boston Scientific, in the announcement. "Our WATCHMAN technology was the first FDA-approved LAAC device on the market and has been implanted in more than 100,000 patients worldwide, and now with the WATCHMAN FLX device, we are taking the clinical benefits of the technology to the next level for more patients while further differentiating our structural heart portfolio in the U.S."

Some results of a recent study of the WATCHMAN FLX, according to Boston Scientific:

Positive 12-month results from the pivotal PINNACLE FLX study, which evaluated the performance of the WATCHMAN FLX device as an alternative to long-term non-vitamin K antagonist oral anticoagulants (NOACs) and other OAC medications, were recently presented as a late-breaking clinical trial at Heart Rhythm Society 2020 Science. The study met its primary safety and efficacy endpoints with data demonstrating a low rate of major procedure-related safety events (0.5% at 7 days post procedure) and high rate of effective LAAC (100% with peri-device flow < 5mm at 12 months post procedure). Data also demonstrated a high implant success rate of 98.8%.

Here's a Boston Scientific promotional video for the WATCHMAN FLX:

Product page: WATCHMAN FLX

Flashbacks: Boston Sci's Next Generation WATCHMAN FLX Stroke-Preventing Device Cleared in EU; Boston Scientific's Unique WATCHMAN Stroke Prevention Device FDA Approved; WATCHMAN Left Atrial Appendage Closure Device Gets CE Mark for Expanded Use; Watching the Watchman (again)

Via: Boston Scientific

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Watchman FLX Next Gen Stroke Prevention Device Now FDA Approved

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Boston Scientific's WATCHMAN, a device that's used to close the left atrial appendage, has done wonders for preventing the formation of clots that lead to stroke in many patients. Now the company has announced that its WATCHMAN FLX, a new and much improved version of the implant, won FDA approval.

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This device eliminates the need for oral anticoagulation in patients with atrial fibrillation. This is significant because many patients are not great candidates for anticoagulation. If patients are a high bleeding risk, being on an oral anticoagulant can be life threatening. Patients could be unable to afford oral anticoagulants and potentially noncompliant because of that.

The watchman FLX is superior to other atrial appendage clips because it comes in different sizes to accommodate all different types of anatomy. It also has the lowest rate of low major adverse events.

One additional feature to the watchman FLX is that it has superior rates of the closure of the atrial appendage. After being placed, the skin is endothelialized and closes off the appendage. 100% of patients had a closed LAA within 12 months.

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The period after placing the device till the next seven days has a 0.5% chance (2/400) having a ischemic stroke.

There were no patients that required open heart surgery after placement of the device (due to error when placing the device).

There are minimal issues with placement of this device.

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This device is made by boston scientific. This is a large company that has made many innovations for modern medicine.

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Advancing Science for Life - US - Boston Scientific

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Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world.

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I think that this is a great device to decrease the need for oral anticoagulation. Anticoagulants can be so dangerous for patients and this eliminates the need for them with little risk. Especially for elder patients with atrial fibrillation, this is a great alternative option. Anticoagulants can put these patients at high risk for all types of bleeds and be very dangerous. Also, if the patient is needing any emergency surgery, anticoagulants can be a big problem.

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My personal strengths are achiever, maximizer, learner, focus, and significance.

My strengths will help the team because I like to increase my knowledge as much as I can to have the best outcomes. I have the stamina to get through a project and complete it with a goal in mind. I value being important to others therefore I work well in groups. I believe my strengths along with everyone else’s will make for a solid team.

Daisy (developer), Carter (communication), Angelica (analytical), Sheila (stragtegic), William (woo).

I have chose each of these individuals because I think this would make for a great team if we are trying to get our facility to take this device into its practice. Daisy will be good at helping everyone improve on skills like how they present the device. Carter will be useful to express all of the data we have found and communicate it in a way that is effective. William will compliment carter well by having a personality that is very likeable. When presenting, these two can be very pursuasive and effectively get the job done. Sheila and Angelica will be good team members to collect data and know what they want to see. This can mean comparing it to current data within and outside of the hospital. Sheila can effectively put together the data and information to present and be prepared for anything unexpected. I believe as a team, the 6 of us can evaluate if this product is something our facility could effectively use.

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Watchman FLXTM left Atrial Appendage Closure device. www.watchman.com. (n.d.-b). https://www.watchman.com/en-us-implanter/device/watchman-flx.html

FDA update: Watchman FLX pro left atrial appendage closure device receives FDA approval. American College of Cardiology. (2023, September 7). https://www.acc.org/latest-in-cardiology/articles/2023/09/07/12/43/fda-update-watchman-flx-pro-left-atrial-appendage-closure-device-receives-fda-approval#:~:text=The%20WATCHMAN%20FLX%20Pro%20device,with%20larger%20left%20atrial%20appendages.

Watchman FLX brief summary. www.watchman.com. (n.d.). https://www.watchman.com/en-us-implanter/brief-summary.html

Watchman Device. (n.d.). What to Expect Before, During and After the WATCHMAN Device Procedure. Retrieved January 17, 2024, from https://www.rwjbh.org/treatment-care/heart-and-vascular-care/tests-procedures/left-atrial-appendage-closure-laac-/what-to-expect/.

Overview watchman FLX LAAC Pinnacle Flx Ide Clinical Study. www.watchman.com. (n.d.-a). https://www.watchman.com/en-us-hcp/clinical-evidence/pinnacle-flx.html

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Scroll down to the bottom and click on patient education video.

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WATCHMAN LAAC Physician and Patient Resources for the Referral Process

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Referring your NVAF patients for WATCHMAN to an implanting physician is an easy 3-step process: educate, document, and send. Downloadable tools are available.