Boston Scientific (NYSE:BSX) has seen shares dip nearly 5% today after it announced a voluntary recall of all its Lotus Valve devices over issues with its locking mechanism, not expecting the platform to return to the market until the 4th quarter.
The Marlborough, Mass.-based company said it is removing all Lotus valve devices, including its Lotus with Depth Guard, from global commercial and clinical sites “due to reports of premature release of a pin connecting the Lotus Valve to the delivery system.”
Boston Scientific said it believes the issue is caused by an excess of tension in the pin mechanism introduced during the manufacturing process, the same issue that caused an earlier suspension of implants of its Lotus Edge valve system device, according to an SEC filing.
The company said it anticipates a return for the Lotus valve devices in the EU and other regions during the 4th quarter, with an anticipated PMA submission for its Lotus Edge valve system during the same quarter, with a hopeful approval and launch in mid-2018.
Shares have tumbled in response, down over 4% to trade at $24.15 as of 11:00 a.m. EST. Update – shares have risen slightly to close at $24.47.
Boston Scientific’s competitors have seen a positive day on Wall Street, with Edwards Lifesciences up 3.8% to close at $95.71 and Medtronic up 1.4% to close at $80.76.
The recall comes only days after the company presented new data from the Respond extension study of the Lotus valve with Depth Guard technology, with the company touting no deaths and low rates of paravalvular regurgitation.
Results from the trial indicated a 0% mortality rate upon discharge at 7 days. A total of 85.3% of patients in the trial reported no or trivial amounts of paravalvular leaks, while no moderate or severe PVLs were reported. Mild PVL was reported in 14.7% of patients.
In January, Boston Scientific had reportedly found a fix for its Lotus Edge heart valve after the company paused implantations of the device in October last year.
The company expects to submit a premarket application to the FDA in May, according to a Barclays report. The submission time would position Boston Scientific for approval by the end of the year, with a launch in early 2018.
Join us Oct. 8-10 for the 7th annual DeviceTalks Boston, back in the city where it all began.
DeviceTalks offers three days of world-class education, networking, and a technology exhibition featuring the leading companies in the industry.
Early Registration is now open.