Left atrial appendage (LAA)-implanted occlusion devices have been dominating the structural heart occluders market, which GlobalData forecasts to exceed $7 billion by 2033. Between 2015 and 2022, LAA-implanted occlusion devices experienced a highly aggressive compound annual growth rate of 25%, rising from $132 million to $1.79 billion. This exponential growth was chiefly driven by sales of Boston Scientific’s Watchman FLX device, which currently possesses a 94% market share of the LAA-implanted occlusion device market.
The Watchman FLX is a structural heart device that physicians implant in the LAA of patients with atrial fibrillation to prevent the formation of a blood clot that would lead to a stroke. Typically, physicians prescribe blood-thinners before deploying an LAA-implanted closure device. However, if patients have contra-indications against blood-thinners, LAA-implanted occlusion devices then become the recommended treatment.
Since receiving both FDA and CE mark approvals in 2019, the Watchman FLX has been implanted in over 300,000 patients, according to Boston Scientific’s 2022 financial report. But while the device is used aggressively in the US and Europe, such exponential growth cannot be assumed in other countries once the Watchman becomes commercially available there.
There is particularly strong opposition to its use in India, where doctors consider it a last resort for treating atrial fibrillation. Since its introduction in the country in 2017, only around 50 LAA closure procedures have been carried out, according to GlobalData’s estimates.
Doctors in India are generally opposed to the implantation of the Watchman device for the following reasons — the procedure’s expense, its associated adverse events and its complexity. Although the Watchman device has been extremely successful in the US and Europe, it has yet to make its mark in some countries.