WATCHMAN FLX left atrial appendage closure (LAAC)Courtesy of Boston Scientific
Boston Scientific has initiated a study that will compare the Watchman FLX left atrial appendage (LAA) closure device’s safety and effectiveness to that of anticoagulants for reducing stroke risk in atrial fibrillation patients in a new trial.
The randomized, controlled OPTION trial will enroll 1,600 patients with non-valvular AFib who are suitable for oral anticoagulants (OAC) therapy and have recently had or will have an ablation. Patients at as many as 130 global sites will be randomized to receive the newest-generation Watchman FLX device or an OAC, inclusive of commonly prescribed direct oral anticoagulants or warfarin.
The primary effectiveness endpoint is all cause death, stroke and systemic embolism through 36 months, and the primary safety endpoint is non-procedural bleeding through 36 months.
"Beyond advancing the robust clinical literature supporting the Watchman therapy, findings from the OPTION trial have the potential to expand the number of patients with atrial fibrillation who can receive an alternative to life-long anticoagulants and thus avoid their potential side effects," Dr. Ian Meredith, AM, executive vice president and global CMO, Boston Scientific, said in a release. "The unique study design encompasses patients who will receive a Watchman FLX device either after or concurrent to an ablation procedure."
Watchman was a game-changer for the Marlborough, MA-based company. The firm’s acquisition of the technology was only five years removed from its disastrous merger with Guidant.
However, it wasn’t smooth sailing for Watchman on the regulatory pathway. FDA rejected it once, and even after a panel had recommended approval a second time, the agency requested a third panel review. This caused analysts to speculate that the technology could have a narrowed label restricting the manner of use.
But that wasn’t the case, and in 2015 Watchman received FDA approval. The device has been a strong revenue driver. Watchman FLX lacks approval in the U.S., however the device received CE mark in March of last year.
Previously, the Watchman FLX had CE mark in 2015, but halted sales of the technology after receiving reports of device embolization.