Summary
Boston Scientific Corp. (BSX) announced on February 23, 2017, a voluntary global removal of all Lotus™ Valve devices, including those with Depth Guard™, from commercial and clinical use. This action is due to reports of a premature release issue with a pin connecting the valve to its delivery system, which the company attributes to excess tension during manufacturing. The company anticipates a return of the Lotus™ Valve platform to markets in Europe and other regions by the fourth quarter of 2017. Furthermore, Boston Scientific plans to file a U.S. Premarket Approval (PMA) submission for its next-generation Lotus Edge™ Valve System in the fourth quarter of 2017, targeting a mid-2018 U.S. launch. Investors should monitor the progress of these timelines and the company's ability to resolve the manufacturing issue.
Key Highlights
- 1Voluntary global removal of all Lotus™ Valve devices due to a premature release issue with the delivery pin.
- 2The issue is attributed to excess tension in the pin mechanism introduced during the manufacturing process.
- 3Company expects the Lotus™ Valve platform to return to market in Europe and other regions in Q4 2017.
- 4U.S. PMA submission for the next-generation Lotus Edge™ Valve System is planned for Q4 2017.
- 5U.S. launch of the Lotus Edge™ Valve System is anticipated for mid-2018.
- 6The announcement includes forward-looking statements regarding timelines, subject to potential risks and uncertainties.