The Marlborough, Mass.-based company, which recalled the Lotus transcatheter aortic heart valve in February over issues with its locking mechanism, said it no longer expects the ensuing manufacturing and design specification changes to get the valve back on the market in Europe or allow the final filing in its pre-market approval bid with the FDA by January 2018.
“We continue to see value in the unique benefits of the LOTUS Valve platform in treating patients with aortic stenosis,” chairman & CEO Mike Mahoney said in prepared remarks. “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.”
Boston Scientific said it plans to deliver an update on the Lotus valve’s status during its fourth-quarter earnings call, slated for Feb. 1, 2018. The delay is not expected to affect its finances for the fourth quarter or full year, the company said, but investors reacted by sending BSX shares down some -7.4% yesterday.
The stock closed at $26.39 per share yesterday after Boston Scientific pulled out of its scheduled appearance at the Piper Jaffray healthcare conference in New York City, but rebounded somewhat this morning in pre-market trading, rising 0.7% to $26.58 apiece. The drop yesterday pared its market cap from roughly $39.1 billion to $36.2 billion.
Last February Boston voluntarily removed 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.”
At the time the company said it believed the issue to be 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.
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.