Boston Scientific Announces Fix for Lotus Edge TAVR Device Following Implantation ‘Pause’

A locking mechanism problem that led Boston Scientific to “pause” implantations of its Lotus Edge TAVR device has been fixed, the company confirmed today to TCTMD.

News of the fix was first published yesterday by Mass Device based on an analyst report from Barclays Capital. To TCTMD, Boston Scientific said they “have identified the issue and a solution—a combination of minor process and specification changes.” They further stated that they expect to submit a PMA to the US Food and Drug Administration (FDA) for Lotus Edge in the second quarter of 2017 and look to secure approval by the end of the year, with full commercial launch of the next-generation valve in the United States in early 2018. The device received CE Mark approval in the European Union in September 2016.

Boston Scientific stopped selling Lotus Edge in Europe soon after the device became available, and the company initiated a voluntary removal of field inventory when the locking mechanism issue came to light. According to Mass Device, Boston Scientific said they had received reports that the device could not be fully locked in some cases, resulting in failure to complete the TAVR procedure. In all cases, Boston Scientific said, the device was recaptured and patients were successfully treated with a new valve. The incidence of locking mechanisms issues with Lotus Edge was reported to be about 4%.

The resolution to the locking mechanism issue with Lotus Edge is unrelated to a recall of certain lots of the first-generation Lotus valve that followed at least three deaths and was reported by TCTMD in August 2016, a company spokesperson clarified to TCTMD. That recall was related to potential breakage of the release mandrel on Lotus Valve Systems manufactured prior to March of 2016.