Topics include rules about pre-release of clinical trial data, safety and efficacy of the Watchman left atrial appendage (LAA) closure device, and market potential of LAA. The meeting featured several speakers including David Holmes, Beth Casteel, and Lawrence Biegelsen.EBSCO_AspMedical Device ...
PINNACLE FLX Clinical Study The PINNACLE FLX US IDE Trial was designed to establish the Procedural Safety and LAA Closure Efficacy with the WATCHMAN FLX LAAC Device. Study Design 400 patient, 29 US site, single arm, non-randomized trial evaluating WATCHMAN FLX for non-inferiority to safety and...
View real-world and clinical data Learn more about WATCHMAN Access resources Access WATCHMAN resources in the referring HCP download center Visit the download center Stay connected Receive monthly updates about the WATCHMAN Implant Sign up for updates ...
WASHINGTON, DC — New, longer-term data on the Watchman left atrial appendage occluder (Boston Scientific) studied in the PREVAIL trial points to an increased risk of ischemic stroke in atrial-fibrillation patients treated with this novel device, a finding that appears to be countered, in part,...
View real-world and clinical data Learn more about WATCHMAN Access resources Access WATCHMAN resources in the referring HCP download center Visit the download center Stay connected Receive monthly updates about the WATCHMAN Implant Sign up for updates ...
The PREVAIL trial, which was (supposed) to be presented here at the American College of Cardiology 2013 Scientific Sessions , was designed to give more data and offer additional safety data. The slides were made available, but due to an embargo break by Boston Scientific, the maker of Watchm...
If the leak is less than 3 mm in diameter, Suradi said he feels comfortable leaving it alone based on data from PROTECT-AF. However, for leaks larger than 3 mm, there are no data available to guide decision-making. At their center, they will perform extensive follow-up with TEE in pat...
Designated discussant Gerhard Hindricks, MD, a co-author of the updated 2020expert consensus statementon catheter-based left atrial appendage occlusion, congratulated the investigators on executing the largest LAAO trial thus far and said it is important because it "brings solid data to a field wh...