Boston Scientific is developing a next-generation Watchman device for left atrial appendage closure, aiming for a U.S. launch in late 2027 or early 2028. The device is designed to offer enhanced stability and adaptability across a wide range of cardiac anatomies. The company plans to begin enrollment for a U.S. investigational device exemption study next year.
Watchman helps reduce stroke risk in atrial fibrillation patients by sealing the left atrial appendage, a key source of blood clots. Boston Scientific’s current Watchman FLX Pro was FDA-approved in 2023. Future growth is expected from label expansion and concomitant procedures, with the Watchman market, currently valued at $2 billion, projected to grow 20% annually.
The Champion-AF trial, comparing the device to long-term blood thinners over five years, is expected to report data in H1 2026. Positive results, along with guideline and reimbursement updates, could expand the device’s potential patient population from 5 million to over 20 million by 2030. About 25% of the U.S. Watchman implants are now performed alongside ablation procedures.
07-10-2025