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

Boston Scientific has announced plans for 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 its market reach and enhance the device's capabilities through ongoing clinical trials and potential label expansions.

Next-Generation Watchman Development

Angelo De Rosa, global president of Boston Scientific's Watchman business, disclosed that the company is developing a new iteration of the Watchman device designed to provide "stability and unprecedented adaptability to each possible anatomy." The company plans to begin enrollment for a U.S. investigational device exemption (IDE) study next year, with hopes to bring the device to market in the second half of 2027 or early 2028.

This announcement comes on the heels of the FDA approval for the third-generation Watchman FLX Pro in 2023, demonstrating Boston Scientific's commitment to continuous innovation in left atrial appendage closure technology.

Market Expansion and Clinical Trials

Boston Scientific foresees significant growth potential for its Watchman business, estimating the current market at $2 billion with an expected annual growth rate of 20%. The company aims to expand the device's indications to cover more than 20 million patients globally by 2030, up from the current 5 million patient base.

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 at Boston Scientific, stated that data from this study is expected in the first half of 2026. Positive results could potentially lead to label expansions, allowing the device to be used in patients who can tolerate long-term anticoagulants but may still benefit from having the Watchman as an option.

Concomitant Procedures and Reimbursement

The company has observed an increasing trend in concomitant procedures, with approximately 25% of Watchman cases in the U.S. being performed alongside ablation therapy for atrial fibrillation. This synergy aligns with Boston Scientific's efforts to grow its ablation business through its Farapulse pulsed field ablation system.

Supporting this trend, the Centers for Medicare and Medicaid Services (CMS) finalized a proposal last year to create a new inpatient payment code for combined left atrial appendage closure and cardiac ablation procedures when performed by the same physician during one operation. This development is expected to further facilitate the adoption of Watchman in conjunction with other cardiac interventions.