Design tweaks to the repositionable Lotus transcatheter aortic valve replacement (TAVR) system have taken longer than expected, as manufacturer Boston Scientific announced it is pushing back the newer-generation Lotus Edge's reintroduction in Europe and entry into the U.S. market.
Earlier this year, the company issued a voluntary recall of all Lotus devices (including Lotus Edge) due to an issue with release of the pin that connects the TAVR device to its delivery system. The recall came just after things were looking up for the Lotus Edge, when a new anchoring mechanism appeared to alleviate its high pacemaker rate.
When the in February, Boston Scientific said it expected to relaunch the newer-generation Lotus Edge in Europe and to file a U.S. premarket approval application by the fourth quarter of 2017.
But in a statement issued Tuesday, the company said that schedule was delayed, and doesn't plan to provide another update until Feb. 1, 2018.
"While we are disappointed in this delay to our timelines, we are working to carefully analyze and implement necessary modifications to pass our rigorous internal quality standards," said Mike Mahoney, chairman and chief executive officer of Boston Scientific, in a .
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