In the market for left atrial appendage closure (LAAC) devices, Boston Scientific Corp.'s WATCHMAN device currently enjoys a monopoly in the US as the only endocardial device on the market. Other companies with endocardial LAAC devices in development or on the market OUS were very happy to see WATCHMAN receive FDA PMA approval in March 2015, as BSX is blazing a regulatory and reimbursement trail that will help open up the market and serve as a foundation for other companies looking to bring their devices to the US market.
While the path to commercial success with LAA closure in the US could bring significant rewards for manufacturers, as well as for patients, challenges remain. Over the next decade, the...
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