Dive Brief:
- Boston Scientific has gained approval for an updated version of its Watchman left atrial appendage closure (LAAC) device in the U.S.
- The U.S. Food and Drug Administration approval covers a device that has a new coating designed to reduce thrombus formation and other improvements over earlier Watchman products, which generated sales of $608 million over the first half of the year, analysts at RBC Capital Markets wrote in a research note.
- The analysts called the Watchman FLX Pro approval an “incremental positive” for Boston Scientific, which has faced competition from Abbott for the past two years.
Dive Insight:
While Boston Scientific no longer has a monopoly on the LAAC market, sales of its Watchman devices continue to accelerate. Global sales of the LAAC devices increased by 26% in the second quarter, making the product line a key growth driver for the medtech company. Boston Scientific has protected its franchise from competition by continuing to update the device.
Having reduced major adverse events and increased the success rate by moving from Watchman 2.5 to Watchman FLX, Boston Scientific has now laid the groundwork for further improvements by winning FDA approval for another update to its LAAC technology.
“One key enhancement is a specialized polymer coating that decreases device-related thrombus formation and promotes quicker, more controlled healing and endothelization of the device surface. We expect Watchman FLX Pro device launch to further improve the procedural performance and safety of the Watchman technology,” the RBC analysts wrote in a note to investors.
The analysts’ confidence in the updated device reflects the revised polymer and new visualization markers designed to facilitate precise device placement. Boston Scientific has preclinical data linking the device to significantly less thrombus and reduced inflammation in a canine model, and is studying the device in humans. A 1,000-subject post-market study is set to start in the coming weeks.