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March 14, 2019

Boston Scientific gets CE-Mark for WATCHMAN FLX device

Boston Scientific has secured the European CE-Mark for the next-generation WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device to reduce the risk of stroke in non-valvular atrial fibrillation (AF) patients.

Boston Scientific has secured the European CE-Mark for the next-generation WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device to reduce the risk of stroke in non-valvular atrial fibrillation (AF) patients.

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AF patients are at higher risk of experiencing a stroke compared to people with normal heart rhythm.

According to data, more than 90% of stroke-causing blood clots from the heart are formed in the left atrial appendage in non-valvular AF patients.

WATCHMAN is a permanent implant intended for closing the left atrial appendage in the heart to mitigate the stroke risk.

The new device is designed to fit a broad range of patients, including those with complex anatomies.

“The robust clinical evidence and successful commercial outcomes of the WATCHMAN device to-date reinforce the value of this procedure for all appropriate patients.”

It comes with a fully enclosed and rounded frame to enable implantation flexibility for customising the placement. Physicians will be able to fully recapture and reposition the device during the procedure.

The WATCHMAN FLX device’s frame allows for improved sealing within the left atrial appendage.

Boston Scientific Interventional Cardiology president Kevin Ballinger said: “The WATCHMAN device has been implanted in more than 75,000 patients worldwide and we are pleased that this next-generation technology has been granted European regulatory approval so that we can offer it to patients and clinicians throughout Europe.

“The robust clinical evidence and successful commercial outcomes of the WATCHMAN device to-date reinforce the value of this procedure for all appropriate patients.”

The company has commenced a limited market release of the new device in Europe, with plans for expansion of the commercialisation in the second half of this year.

Boston Scientific also intends to initiate patient enrolment in a post-approval registry at European sites in the coming months.

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GlobalData's APAC Medical Devices Industry Landscape – 2022 free study breaks down the APAC medical devices market by segment and region and includes insights on local and global competitors, pipeline product developments, clinical trials studies, and significant deals in the industry. The APAC medical device industry witnessed significant developments, launches, implementations, and adoption of new medical device technologies in the past decade, however the high cost of devices, regulatory hurdles, reimbursement pressure, and healthcare budget constraints have challenged market expansion across various territories and segments. APAC is the fastest growing regional market for medical device clinical trials, with China and Japan emerging as major clinical trial hotspots. The growth in medical device clinical trials in the APAC region is attributed to an increase in research partnerships between biopharma companies and clinical research organizations (CROs). This report also provides an in-depth analysis of the medical device market's opportunities and challenges, the influence of COVID-19 on the market, and government activities aimed to develop the APAC medical device market.
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