According a news report on Mass Device, Boston Scientific has “found a fix” for the problem with its next-generation transcatheter aortic valve implantation (TAVI) device. The company paused implantation of the device in October last year (in Europe, where the device has the CE mark) to investigate a potential problem its locking mechanism.
“Boston Scientific update on its Lotus TAVI programme was positive, as chief executive officer Mike Mahoney noted that Boston Scientific 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 USA. Specifically, Boston Scientific 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,” Barclays analyst Matthew Taylor wrote, Mass Device states, in a report to investors
Mass Device quotes Taylor as also saying that the structural heart revenue guidance was slightly below consensus of US$345 million but that he adds that the positive news on the Lotus Edge “outweighs this concern.”
Boston Scientific implanted about 200 of the Lotus Edge transcatheter aortic valve replacements in Europe, according Taylor, encountering about a 4% rate of “some issues with [the] locking mechanism of the valve.” Talyor notes, Mass Device reports, that “in these cases (incidence rate of ~4%), the device was recaptured and a new valve was implanted with no major adverse events”. The company the pulled the valve from the market while it investigated the locking mechanism issue.
Mass Device states that Boston Scientific has said it expects to see structural heart revenue of US$300 million for 2017, up from US$200 million this year, with contributions from its Watchman and Lotus/Lotus Edge devices.