Boston Scientific (NYSE:BSX) said today it plans to submit the final technical module for the FDA premarket approval application for its Lotus Edge aortic heart valve system by the end of next week.
The good news follows a long string of hurdles the Marlborough, Mass.-based company has faced with the Lotus over the past few years.
Last November, Boston Scientific announced news of a delay that resulted in a $3 billion drop in its market capitalization. Earlier that year in February, the company recalled the Lotus TAVR system over issues with its locking mechanism and said it didn’t expect to be able to get the device back on the market in Europe or to file for changes with the FDA by the beginning of 2018.
Boston paused Lotus implantations in October 2016 to investigate a locking mechanism issue but even though that problem was solved by January 2017, the next month the company voluntarily pulled all Lotus devices from global commercial and clinical sites “due to reports of premature release of a pin connecting the Lotus valve to the delivery system.”
This February, CEO Mike Mahoney confirmed that the Lotus will remain off the market for the rest of the year.
Today the company briefly announced progress towards new FDA approval of the valve in an SEC filing.
