BSX’s Anticipated Lotus Valve Relaunch: Not before 2019



BSX’s latest announcement on Lotus relaunch

Boston Scientific released its 4Q17 and 2017 earnings results on February 1, 2018. During its earnings release, the company announced that it expected to relaunch its Lotus device in European and US markets in 2019.

BSX’s Lotus TAVR (transcatheter aortic valve replacement) system helped it enter the attractive TAVR market space with exceptional opportunity for growth. The company added another TAVR device, Acurate, to its portfolio following the completion of its acquisition of Symetis in May 2017. For acquisition details, read Boston Scientific Completes Its Acquisition of Symetis.

Edwards Lifesciences’ (EW) Sapien family of valves is the market leader in the TAVR space. Medtronic’s (MDT) CoreValve is the only other FDA-approved TAVR device on the market. Abbott Laboratories’ (ABT) Portico is another TAVR device undergoing trials. It’s expected to launch in 2019.

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BSX’s Lotus recall developments

The Lotus Edge device received a CE mark and launched in Europe in September 2016. However, the device’s sales were suspended in October 2016 due to manufacturing defects. In January 2017, the company announced that it had found the fix and would soon reintroduce the product into the market. However, BSX’s Lotus valves were recalled in February 2017 owing to a fault in the device’s locking mechanism. The company stated that it was working on the required fixes and expected to relaunch the device in Europe and file a PMA (premarket approval) application in the United States in 4Q17. This application will likely be approved by mid-2018.

A few months later, the company announced a further delay and stated that the expected relaunch would be in 1Q18. However, on November 28, 2017, it announced a further delay in the relaunch of the device, which triggered a stock price fall of 7.5% on the day followed by another 1.5% fall the next day. The Health Care Select Sector SPDR ETF (XLV), however, registered a rise of ~0.73% in its price on November 28. XLV has ~1.1% of its total holdings in BSX.

For more details on this development and Wall Street’s reaction, read What’s behind Boston Scientific’s Recent Stock Fall?

In the next article, we’ll take a look at Boston Scientific’s 4Q17 and 2017 sales results.


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