Exit of Boston Scientific’s Lotus Edge will shake up US transcatheter aortic valve replacement market

Following the news that Boston Scientific is immediately retiring its Lotus transcatheter aortic valve replacement (TAVR) programme;

Ashley Young, Senior Medical Devices Analyst at GlobalData, a leading data and analytics company, offers her view on the news:

“Due to its minimally invasive nature, TAVR is a good alternative for patients who are not suitable candidates for surgery due to their age, frailty or other factors. As such, TAVR has been exploding in popularity amongst physicians in recent years. Since its inception, the TAVR market has been dominated around the world by two major players: Edwards Lifesciences with its Sapien brand and Medtronic with its CoreValve brand.

“Boston Scientific received regulatory approval in Europe for its Lotus Edge TAVR device in 2016 and Food and Drug Administration (FDA) approval in April 2019. In 2019, once the device became commercially available, the company was able to capture a small amount of US market share – approximately 1.5% of the US TAVR market – leading to revenue of just under $30m for the company in the US alone. In the first three quarters of 2020, Boston Scientific’s US TAVR market share grew to 2.24%, bringing with it increased revenue, even in the face of the COVID-19 pandemic, according to GlobalData.

“However, the Lotus Edge device has faced issues in the past. In 2017, while the device was commercially available in Europe, Boston Scientific issued a voluntary recall over issues to do with its delivery system and locking mechanism. The device returned to market later in the same year. However, Boston Scientific has indicated that the current global recall is permanent, with no plans to return the Lotus device to market.

“Prior to this recall, GlobalData had predicted slowly increasing shares for Boston Scientific in the TAVR market as adoption rates for the Lotus Edge continued to climb. In light of this news, however, the forecasted market landscape for TAVR devices will now be different. GlobalData now predicts that the market shares gained by Boston Scientific will be returned to the two remaining competitors – Edwards Lifesciences and Medtronic – until other competitors enter the US market. GlobalData predicts that the US TAVR market could reach over $10bn by 2030.”

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