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July 22, 2021

Boston Scientific’s LAAC device lowers ischemic stroke in trial 

No cases of device embolisation or pericardial effusion linked to the WATCHMAN FLX device were reported in the trial.

Boston Scientific has reported positive data from the PINNACLE FLX clinical trial of its WATCHMAN FLX Left Atrial Appendage Closure (LAAC) device in non-valvular atrial fibrillation (NVAF) patients.

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The prospective, non-randomised trial assessed the safety and efficacy of the device as a substitute to long-term oral anticoagulation treatment for lowering stroke risk in this patient population.

Non-vitamin K antagonist oral anticoagulants (NOACs) were included in the study as anticoagulation therapy.

The trial enrolled a total of 400 anticoagulant-eligible subjects in the US who sought a non-pharmaceutical alternative.

Data showed that the trial met the secondary efficacy goal with a 3.4% rate of systemic embolism or ischemic stroke incidence at 24 months versus the 8.7% performance goal.

As per the previously reported 12-month data, the trial met its primary safety and efficacy goals.

Furthermore, the latest results found that no trial subject reported device embolisation or pericardial effusion needing cardiac surgery, which is favourable with respect to earlier clinical trials.

Boston Scientific global chief medical officer Dr Ian Meredith said: “The final results of this pivotal study underscore how to design advancements of the WATCHMAN FLX device – which allow for improved anchoring, a faster, more effective LAA closure and compatibility with more complex anatomies – have translated into a safe, effective and durable option for patients with NVAF at increased risk for stroke and systemic embolism and an appropriate rationale to seek a non-pharmaceutical alternative.”

In March 2019, the WATCHMAN FLX device received CE mark, and it was approved by the US Food and Drug Administration in July last year.

Currently, two prospective, randomised controlled trials, OPTION and CHAMPION-AF, are evaluating the WATCHMAN FLX device in NVAF patients.

The OPTION trial is comparing the device to oral anticoagulants in patients undergoing a cardiac ablation procedure while CHAMPION-AF is assessing the device versus NOACs to prevent embolic stroke in wider anticoagulant-eligible patients.

Last month, Boston Scientific exercised its right to acquire the remaining 73% shares in medical device company Farapulse for an upfront payment of nearly $295m.

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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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