News | Left Atrial Appendage (LAA) Occluders | July 22, 2020

FDA Clears Next-generation Watchman FLX Left Atrial Appendage Occluder

New stroke risk reduction technology designed to advance procedural performance and safety, treat wider range of patients with non-valvular atrial fibrillation

The U.S. Food and Drug Administration (FDA) has approved Boston Scientific's next generation Watchman FLX Left Atrial Appendage Closure (LAAC) Device.

July 22, 2020 — The U.S. Food and Drug Administration (FDA) has approved Boston Scientific's next generation Watchman FLX Left Atrial Appendage Closure (LAAC) Device.

The Watchman FLX is indicated to reduce the risk of stroke in patients with non-valvular atrial fibrillation (NVAF) who need an alternative to oral anticoagulation therapy by permanently closing off the left atrial appendage – the area of the heart where stroke-causing blood clots commonly form in NVAF. 

The redesigned device is built on the most studied and implanted LAA occluder device in the world. It features a new, fully rounded design that offers physicians the ability to safely enter, and maneuver within, the left atrial appendage. It is the first LAA occluder that can be fully recaptured, repositioned and redeployed for precise placement, and the new frame design allows for optimal device engagement with the tissue for long-term stability and a faster, more complete seal. The Watchman FLX device is available in broader size options than the previous generation device and can treat a wider range of patient anatomies.

"The device sizes have much more overlap among each other, which allows for higher compression ratio by 10-30 percent, which allows me to choose among the devices in a more precise manner. That helps with choosing the right device for the anatomy rather than trying to fit a device into the appendage," explained Devi Nair, M.D., an electrophysiologist at St. Barnards Medical Center, Jonesboro, Ark. 

Closeup of the Watchman FLX LAA occluder showing the securement spikes to prevent embolization of the device.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%.

"Built upon the success of the Watchman platform and thousands of patient-years of clinical research, the next-generation Watchman FLX device is designed to offer increased ease of use for physicians and improved procedural outcomes for patients, including reduced complication risk and healing time," said Dr. Ian Meredith, AM, global chief medical officer, Boston Scientific. "We've set the bar high and look forward to bringing these benefits to a wider range of U.S. patients with NVAF who need an alternative to the bleeding risk and lifestyle challenges associated with long-term use of blood thinners."

Additional clinical research using the Watchman FLX device for patients with NVAF will continue via enrollment in the OPTION trial – comparing the device to oral anticoagulants in patients who also undergo a cardiac ablation procedure – as well as in the CHAMPION-AF trial, which will study a broader OAC-eligible patient population in a head-to-head fashion to compare the device against NOACs.

"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. "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."

The company announced CE mark for the next-generation Watchman FLX device in March 2019 and will immediately commence a limited launch of the device in the U.S. 

For more information: www.watchman.com/implanter

See an overview and demonstration video of the new LAA occluder: https://www.multivu.com/players/English/8707351-boston-scientific-watchman-flx-device-fda-approved/

Related Content on the Watchman FLX LAA Occluder:

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

Occluding the Left Atrial Appendage (LAA)

Update for LAA Occluder Technology News and Trends

PINNACLE FLX Study of New Watchman FLX LAA Occluder Meets Safety and Efficacy Endpoints 

Watchman FLX in Clinical Trial at MedStar Heart and Vascular Institute

Boston Scientific Initiates OPTION Trial of Watchman FLX

 

 

Related Content

Rhythm Therapeutics gene, stem cell, therapy for atrial fibrillation.
News | Atrial Fibrillation | April 19, 2021
April 19, 2021 — National Heart, Lung, and Blood Institute (NHLBI) has awarded a grant for $462,689 to Rhythm Therape
Medtronic's DiamondTemp Ablation (DTA) system is FDA cleared to treat patients with recurrent, symptomatic paroxysmal atrial fibrillation (AF) and who have been unresponsive to drug therapy. The DiamondTemp system is the first FDA-approved, temperature-controlled, irrigated radiofrequency (RF) ablation system with diamonds currently available to deliver ablations.

Medtronic's DiamondTemp Ablation (DTA) system is FDA cleared to treat patients with recurrent, symptomatic paroxysmal atrial fibrillation (AF) and who have been unresponsive to drug therapy. The DiamondTemp system is the first FDA-approved, temperature-controlled, irrigated radiofrequency (RF) ablation system with diamonds currently available to deliver ablations.

News | Atrial Fibrillation | January 29, 2021
January 29, 2021 — The U.S.
Patients with atrial fibrillation are at far greater risk of a catastrophic COVID outcomes, so steps should be taken to reduce AFib risks in addition to precautions against COVID like making, hand washing and social distancing. Images include an electromap from an AF ablation procedure and a COVID-19 from the CDC. 

Patients with atrial fibrillation are at far greater risk of a catastrophic COVID outcomes, so steps should be taken to reduce AFib risks in addition to precautions against COVID like making, hand washing and social distancing. Images include an electromap from an AF ablation procedure and a COVID-19 from the CDC. 

Feature | Atrial Fibrillation | January 27, 2021 | By John D. Day, M.D., T. Jared Bunch, M.D., and Matthew D. LaPlante
In our most challenging and distressing days, it is nice to think about a post-COVID-19 world. 
ECG with paroxysm correct form of atrial flutter. Getty Images

ECG with paroxysm correct form of atrial flutter. Getty Images

News | Atrial Fibrillation | December 23, 2020
December 23, 2020 — The American College of Cardiology (ACC) and the American Heart Association (AHA) has made two up
The three-year clinical outcomes of the mHealth Screening to Prevent Strokes (mSToPS) study evaluated the detection of silent, or previously undiagnosed, atrial fibrillation (AF) in moderate-risk individuals using the FDA-cleared Zio by iRhythm ambulatory monitoring patch. The results support the clinical value of early screening and targeted detection in moderate-risk populations. #AHA #AHA20 #AHA2020

The three-year clinical outcomes of the mHealth Screening to Prevent Strokes (mSToPS) study evaluated the detection of silent, or previously undiagnosed, atrial fibrillation (AF) in moderate-risk individuals using the FDA-cleared Zio by iRhythm ambulatory monitoring patch. The results support the clinical value of early screening and targeted detection in moderate-risk populations.

News | Atrial Fibrillation | November 16, 2020
November 16, 2020 — The three-year clinical outcomes of the mHealth Screening to Prevent Strokes (mSToPS) study evalu
The Medtronic SEEQ mobile cardiac telemetry system, pictured here, and the Icentia CardioSTAT cardiac rhythm monitoring device both found in reased rates of post-operative atrial fibrillation in the SEARCH-AF trial presented at the American Heart Association annual meeting. #AHA #AHA20 #AHA2020

The Medtronic SEEQ mobile cardiac telemetry system, pictured here, and the Icentia CardioSTAT cardiac rhythm monitoring device both found in reased rates of post-operative atrial fibrillation in the SEARCH-AF trial presented at the American Heart Association annual meeting.

News | Atrial Fibrillation | November 16, 2020
November 16, 2020 — Atrial fibrill...
The Medtronic Arctic Front cryoballoon balloon was used a a front-line treatment of AF in the EARLY-AF trial. It was found to be better than anti-arrhythmic drugs in preventing the recurrence of abnormal heart rhythm (atrial tachyarrhythmia, atrial fibrillation), and improve patient well-being.  #AHA #AHA2020 #AHA20

The Medtronic Arctic Front cryoballoon balloon was used a a front-line treatment of AF in the EARLY-AF trial. It was found to be better than anti-arrhythmic drugs in preventing the recurrence of abnormal heart rhythm (atrial tachyarrhythmia, atrial fibrillation), and improve patient well-being.  

News | Atrial Fibrillation | November 16, 2020
November 16, 2020 – Doctors from the Mo...