The FDA recently issued an alert regarding Boston Scientific’s Watchman product, a heart implant used to reduce risk of stroke in patients with non-valvular atrial fibrillation, which has been linked to 120 serious injuries and 17 deaths. The incident is likely to hurt sales for the company in the structural heart occlusion market, which was worth an estimated $4.7 billion in 2024 and is expected to reach $10.3 billion in 2034, according to GlobalData.
The specifics surrounding the incidents involve the access systems used during implantation procedures for sedated patients who had an increased risk of air entering the bloodstream.
Aidan Robertson, Medical Analyst, GlobalData, comments, “This development does not reflect well on Boston Scientific. While the measures to prevent further deaths are trivial, the harm caused to patients is quite significant and may result in a less favourable sales environment in the left atrial appendage closure device (LAA) space for the company.”
According to GlobalData, Boston Scientific currently dominates the structural heart occlusion market, occupying a share of approximately 57 per cent. Competitors such as Abbott Laboratories and AtriCure account for an estimated 21.7 per cent and 9.5 per cent of the market, respectively. More specifically, in the LAA device market, Boston Scientific accounts for a larger 72.6 per cent of the market, while Abbott and AtriCure hold 12.5 per cent and 11.2 per cent, respectively.
The overall structural heart occlusion market is expected to continue to expand due to the increasing population of older aged adults with congenital heart diseases. The expansion is also driven by a growing preference for minimally invasive structural heart procedures, which, in turn, is driving research and development spending with the goal of creating more technologically advanced products. However, some growth may be hindered due to restricted accessibility to these procedures due to high costs, especially in underdeveloped countries.
Robertson concludes, “Any major changes are not expected to occur in the hierarchy of the structural occlusion device market because of Boston Scientific’s dominance in this space. However, some negative impact is expected to sales because of the latest incidents, as they could provide an opportunity for competitors looking to increase their market shares as the patient population and healthcare community may look to safer products. As the market continues to grow, the shift away from the Watchman device towards alternative heart implants is expected to happen.”