Boston Scientific, which earlier this year recalled its Lotus range of heart devices, said it was delaying the commercial release in the U.S. and Europe of its Lotus Edge aortic valve system. The news sent shares of the company tumbling 7.44% in trading Tuesday.
After last February’s voluntary recall of the Lotus and Lotus Edge devices following reports of problems with the locking mechanism, Boston Scientific revamped its design and manufacturing processes with the intent of re-introducing the product in the European market in early 2018 and applying for a PMA module with the FDA in January, the company said.
The company’s technology is used in TAVR, a minimally invasive procedure to replace a narrowed aortic valve that fails to open properly. Edwards Lifesciences is seen as a leader in the TAVR market, which analysts have pegged at surpassing the $5 billion mark by 2021.
An updated timeline for the Lotus Edge valve is expected to be addressed during the company’s fourth-quarter earnings call scheduled for Feb. 1, 2018.
"We continue to see value in the unique benefits of the Lotus Valve platform in treating patients with aortic stenosis," Mike Mahoney, chairman and CEO, said in a statement. “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."
The company said it is working with U.S. and European regulators and providing updates about the delays. Additionally, it said the delay won’t have a material financial impact on either fourth-quarter or full-year 2017 guidance.