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Boston Scientific study shows benefits of Watchman atrial appendage closure
Boston Scientific has announced positive findings of a real-world data analysis conducted among patients fitted with its Watchman left atrial appendage closure device.
The EWOLUTION registry evaluated 1,025 patients with non-valvular atrial fibrillation and a high risk for stroke and systemic embolism, examining Watchman's safety and efficacy performance one year after implantation of the device.
An 84 percent reduction in annual stroke rates was associated with the product, as compared to predicted rates of untreated patients with similar risk profile, as well as a reduction of 48 percent in major bleeding rates compared to those treated with warfarin.
More than 70 percent of the patients were deemed unsuitable for short or long-term anticoagulation at the time of Watchman implantation, with around half experiencing transient ischaemic attacks, ischaemic stroke, vascular disease and a history of major bleeding.
Dr Kenneth Stein, senior vice-president and chief medical officer for Boston Scientific's rhythm management and global health policy division, said: "We are pleased to see that these real-world results reinforce the positive outcomes observed in our clinical trial programme, despite the registry patients being older and sicker than those enrolled in our previous trials."
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