- Citing the implementation of manufacturing and design changes, Boston Scientific (NYSE:BSX) will delay the commercialization of its LOTUS Edge Aortic Valve System. It expects to reintroduce the device in Europe next quarter and file the final PMA module in the U.S. by January.
- The company will update investors on the situation during its Q4 earnings call on February 1, 2018. It says the delay will not have a material impact on its Q4 or full-year guidance.
- The company voluntarily recalled LOTUS and LOTUS Edge earlier this year on reports of the premature release of a pin connecting the valve to the delivery system.
- Management will host a conference call this morning at 8:30 am ET to discuss the issue.
- Shares are off 1% premarket on light volume.
- Previously: Boston Scientific recalls Lotus Valves due to possible manufacturing defect; shares slump 7% (Feb. 23)
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