The Marlborough, Mass.-based company expects to submit a premarket application to the FDA in May, according to a Barclays report. The submission time would position Boston Scientific for approval by the end of the year, with a launch in early 2018.
Boston Scientific said it expects to see structural heart revenue of $300 million for 2017, up from $200 million this year, with contributions from its Watchman and Lotus/Lotus Edge devices.
Barclays analyst Matthew Taylor said the structural heart revenue guidance was slightly below consensus of $345 million, but added that the positive news on the Lotus Edge “outweighs this concern.”
“BSX’s update on its Lotus TAVR program was positive, as CEO Mike Mahoney noted that BSX has identified the fix for its Lotus Edge product and there is no change to expectations for a late 2017 approval and early 2018 launch of Lotus in the US. Specifically, BSX has identified minor process and specification changes that will correct its Lotus issues and expects to submit its PMA for Lotus in the US in 2Q17 (May) and will be back in Europe selling Edge in 3Q17,” Taylor wrote in a letter to investors.
In October, Boston Scientific paused implantations of its next-generation Lotus Edge replacement heart valve in Europe to investigate a locking mechanism issue.
The company implanted about 200 of the Lotus Edge transcatheter aortic valve replacements in Europe, according to Barclays analyst Taylor, encountering about a 4% rate of “some issues with [the] locking mechanism of the valve.”
“In these cases (incidence rate of ~4%), the device was recaptured and a new valve was implanted with no major adverse events,” Taylor wrote in a note to investors.
The company pulled Lotus Edge from the market in Europe, where it won CE Mark approval last September, so it can figure out the problem.