Boston Scientific Unveils Plans for Next-Generation Watchman Device, Targets Market Expansion

Boston Scientific has announced its plans to develop a new version of its Watchman device, aiming to launch the next-generation system in late 2027 or early 2028. The company also revealed strategies to expand the market for its left atrial appendage closure technology, including potential label expansions and increased use in concomitant procedures.

Next-Generation Watchman Device in Development

Angelo De Rosa, global president of Boston Scientific's Watchman business, stated that the company is working on a version of Watchman that "will provide an answer, stability and unprecedented adaptability to each possible anatomy." The development of this new device underscores Boston Scientific's commitment to innovation in the field of stroke risk reduction for patients with atrial fibrillation.

Boston Scientific plans to begin enrollment for a U.S. investigational device exemption (IDE) study next year. This study will be crucial in gathering the necessary data for regulatory approval and eventual market launch.

Market Expansion and Label Extension

The company sees significant growth potential in its Watchman business, estimating the current market at $2 billion with an expected annual growth rate of 20%. Boston Scientific aims to expand the indications for Watchman to cover more than 20 million patients globally by 2030, a substantial increase from the current 5 million patients served.

A key component of this expansion strategy is the ongoing Champion-AF study, which compares the Watchman implant to blood thinners over a five-year period. Brad Sutton, chief medical officer of AF Solutions, stated that the company expects data from this study in the first half of 2026. Positive results could lead to a label expansion, allowing Watchman to be used in patients who can tolerate long-term anticoagulants but may benefit from having the device as an option.

Concomitant Procedures and Reimbursement

Boston Scientific reported an increasing trend in the use of Watchman during concomitant procedures, particularly in patients undergoing ablation for atrial fibrillation. Approximately 25% of Watchman cases in the U.S. are now performed alongside ablation therapy.

Supporting this trend, the Centers for Medicare and Medicaid Services recently finalized a proposal to create a new inpatient payment code for left atrial appendage closure and cardiac ablation when both procedures are performed by the same physician during one operation. This development is expected to further boost the adoption of Watchman in combination with other cardiac procedures.