Boston Scientific Announces FDA Approval of New Indication for WATCHMAN FLX and WATCHMAN FLX Pro as Part of Integrated Atrial Fibrillation Solution

Jul 21, 2025 22:15 CST Updated 22:15

Boston Scientific

Medical Device Manufacturer

Boston Scientific announces FDA approval of new indications for Watchman FLX and Watchman FLX Pro, allowingWatchman FLX and Watchman FLX ProFor non-valvular atrial fibrillation patients who have undergone catheter ablation, with the addition of a postoperative medication regimen in the device labeling.

This timeWatchman FLX and Watchman FLX Pro New Indications Approved Based on Boston Scientific'sOPTION Clinical Study. This clinical study confirmed:Compared with first-line oral anticoagulants (OAC, including direct oral anticoagulants (DOAC) (95%) and warfarin (5%)),Watchman FLXCan effectively reduceStroke Risk in Non-Valvular Atrial Fibrillation Patients After Cardiac Ablation (For specific study data, see "WATCHMAN FLX: Combined AF Ablation Shows Significantly Higher Safety Compared to AF Ablation + Oral Anticoagulants》）

WithWatchman FLX and Watchman FLX Pro Receive Approval for New IndicationsWatchman FLX and Watchman FLX Pro will become another strong growth driver for Boston Scientific.Engine, continue to keep Boston Scientific Corporation in double-digit high growth. AndWatchman andThe combined use of FARAPULSE will create a 1+1>2 effect, allowing Boston Scientific to take the initiative in the competition within the atrial fibrillation field.

Market Analysis

"We are pleased to see Boston Scientific officially expand its indications to cover patients post-ablation, marking an important milestone in validating the value proposition of Watchman in the combined application of left atrial appendage closure and pulsed field ablation (PFA). No adjustment to related performance forecasts is needed, and we reiterate our Buy rating."

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WATCHMAN FLX Pro

WATCHMAN FLX ProIt is a product designed for the permanent closure of the left atrial appendage to reduce the risk of stroke in patients with non-valvular atrial fibrillation (NVAF).

WATCHMAN FLX ProRetaining many excellent features of the WATCHMAN FLX, such as the fully rounded design, which allows physicians to safely access and operate within the left atrial appendage. It can be fully recaptured, repositioned, and redeployed for precise placement. The stent design enables optimal engagement between the device and tissue, ensuring long-term stability and faster, more complete sealing. At the same time,WATCHMAN FLX ProAlso optimized and upgraded based on the WATCHMAN FLX.Compared toWATCHMAN FLX，WATCHMAN FLX ProShanghai University Technology Upgrade:

Coating Technology

WATCHMAN FLX ProAdopted the HEMOCOAT coating technology. HEMOCOAT is a durable anti-thrombotic coating that reduces inflammation and leads to faster, more complete endothelialization.

HEMOCOAT Coating is a very thin coating applied toWATCHMAN FLX ProThe healing surface maintains the aperture and mechanical properties (<1μm) of the WATCHMAN FLX platform.

Preclinical studies have shown,WATCHMAN FLX ProInflammation Three Days Post-OperationDecreased by 86%. Postoperative Day 14Thrombus reduced by 70%. Endothelial tissue coverage increased by 50% at 45 days post-operation.

Radiopaque Marker

WATCHMAN FLX ProIncreasedThree new imaging markers designed to enhance positioning and anchoring performance.

According to the researchVisibility increased by 57%, allowing for more accurate positioning of the device and optimal sealing of the left atrial appendage. The addition of radiopaque markers also improved performance.Visualization during drag testing for instrument anchoring assessment and alignment.

Large Size

WATCHMAN FLX ProIn WATCHMAN FLXOn the basis of the existing options, a new diameter of 40mm has been added. This additional specification accommodates a wider range of patients' anatomical structures, allowing physicians to use the WATCHMAN technology to treat more patients.

WATCHMAN FLX ProApplicable to different sizes of the left atrial appendage (20mm - 40mm).

WATCHMAN FLX Pro Demonstration

Boston Scientific

Boston Scientific is a technology company dedicated to the medical field, and has been at the forefront globally. It has manufactured a wide range of medical devices and conducted extensive medical research that are widely used in many countries around the world. It is committed to innovating for life.We are committed to innovative medical solutions to improve the lives of patients worldwide.For more than 30 years, Boston Scientific has been leading the development of the global medical technology industry by providing a wide range of high-performance medical solutions to meet the urgent healing needs of patients and reduce healthcare costs.