A delay in returning its Lotus Edge Aortic Valve System to the market has cost Boston Scientific an estimated $3B loss in market capitalization.
A delay in returning its Lotus Edge Aortic Valve System to the market has cost Boston Scientific an estimated $3 billion loss in market capitalization.
Boston Scientific announced the delay on Tuesday and the company’s share prices dropped from $28.62 to $26.39. Shares continue to drop some this morning. As of 11:04 a.m., shares are trading at $26.17.
Boston Scientific first issued a voluntary recall of the valve system earlier this year due to concerns over the device’s locking system. The recall forced Boston Scientific to delay submission for marketing approval for the Lotus Edge device to the U.S. Food and Drug Administration. The device had been approved for use in Europe several years ago.
At the time of the recall, Mass Device noted that the company believed the problems with the device were caused by “an excess of tension in the pin mechanism introduced during the manufacturing process.” Mass Device noted that this was a similar issue that caused an earlier suspension of implants of its Lotus Edge valve system device.
The company initially aimed to return the device to the European market and filing the final Pre-Market Approval (PMA) module with the U.S. Food and Drug Administration by January 2018. However, the company announced Tuesday that it will not hit that goal. Instead Boston Scientific said it will provide an update on the status of the Lotus Edge Valve during its fourth quarter 2017 earnings conference call on Feb. 1, 2018. Boston Scientific said it is focused on manufacturing and regulatory milestones to support the long-term success of the Lotus platform.
“We continue to see value in the unique benefits of the Lotus Valve platform in treating patients with aortic stenosis,” Boston Scientific Chief Executive Officer Mike Mahoney 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.”
Boston Scientific said it will continue to work closely with the U.S. and European regulatory bodies to “share pertinent updates about these delays and impact to submission timing.” The company said the Lotus Valve delay is not expected to have a “material financial impact” to its fourth quarter or full year 2017 guidance.
Earlier this month, Boston Scientific initiated a voluntary recall of its 150mm Eluvia drug-eluting vascular stent, as well as its 180mm and 200mm Innova self-expanding stent system. The company said it was pulling these particular devices due to the number of complaints that it received relating to partial stent deployment.
Last year the company saw several FDA approvals, including two catheters that can be used with the Rhythmia Mapping System and approval for a suite of products deemed safe for use in MRI environments, including two new pacemakers and a pacing leads system.
