The US Food and Drug Administration recently published an alert regarding Boston Scientific’s Watchman product, a heart implant used to reduce the risk of stroke in patients with non-valvular atrial fibrillation, as it has been linked to 120 serious injuries and 17 deaths. This is likely to hurt sales for the company in the structural heart occlusion device market, which was worth an estimated $4.7bn in 2024 and is expected to reach sales of $10.3bn in 2034, according to GlobalData, a leading data and analytics company.
This development does not reflect well on Boston Scientific. While the measures that Boston Scientific will need to take to prevent further deaths are trivial, which require the use of ventilation or control of patient breathing, the harm caused to patients is quite significant and may result in a less favourable sales environment in the left atrial appendage (LAA) closure device space for the company. The specifics surrounding the incidents involve the access systems used during the implantation procedures for sedated patients, which had an increased risk of air entering the bloodstream.
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The overall structural heart occlusion market is expected to continue to expand due to the fact that the population of older adults with congenital heart diseases is also increasing, as well as the growing preference for minimally invasive structural heart procedures. In turn, this 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 from high costs, especially in underdeveloped countries.
Boston Scientific currently dominates the structural heart occlusion market, making up approximately 57% of the market. Competitors such as Abbott Laboratories and AtriCure take up an estimated 21.7% and 9.5% of the market, respectively. In the LAA device market, Boston Scientific accounts for a larger 72.6% of the market while Abbot and AtriCure account for 12.5% and 11.2% of the market, respectively.
No major changes are expected to occur in the hierarchy of the structural occlusion device market because of Boston Scientific’s dominance in this space. However, these incidents could have a negative impact on the company’s sales. This could provide an opportunity for some of its competitors that are looking to increase their market shares, as the patient population and healthcare community may look to products with less of a connection to procedural deaths. As the market continues to grow, this shift away from the Watchman device towards alternative heart implants may be seen.
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By GlobalData
