Lotus Valve’s Return to Market in Europe Sees Further Delays

Boston Scientific announced late Tuesday that tests on the Lotus Valve and its delivery system have revealed further problems, prompting the company to delay plans to reintroduce its Lotus Edge Aortic Valve System in Europe and to postpone plans to initiate the premarket approval (PMA) process with the US Food and Drug Administration.

As previously reported by TCTMD, Boston Scientific elected to recall all Lotus valves worldwide back in February—the device holds CE Mark approval in Europe but is investigational in the United States—due to a faulty pin on the device delivery system. Several times in the past year, including at EuroPCR, company spokespeople and investigators for REPRISE III have said that the device had gone through extensive testing and would likely return to European and other markets late before the end of 2017.

On an investors call today, however, company executives acknowledged new information has come to light suggesting that while the valve itself is performing well, and clinical results remain “very good,” they continue to see problems with the delivery system. Only after finishing and analyzing these test results will the company have a clearer timeline for the device.

According to Mike Mahoney, chairman and chief executive officer at Boston Scientific, the company was conducting final design tests in the lead-up to TCT 2017.

“Unfortunately while completing the product testing required for our regulatory submissions, we did encounter some unexpected validation challenges, which will require additional attention from our internal teams,” he said. “As such, while we don’t yet know the full extent of the implications of the product testing results, we do know that we will be unable to meet our prior timeline guidance for US PMA filing by January 2018 and European relaunch by the first quarter of 2018. These results are surprising and recent, and we have moved as quickly as possible to inform investors and physicians that we will not be able to meet our previously communicated guidelines.”

Responding to questions on the call, Kevin Ballinger, executive vice president and global president of interventional cardiology for Boston Scientific, noted that the update provided during TCT reflected the “good, predictable performance test results” the company had been seeing prior to the meeting. “Unfortunately,” he added, “as the final tests were completed and analyzed, we saw elements of system performance that frankly didn’t meet our expectations and honestly surprised us a bit towards the end.”

Asked to speculate as to why Lotus seemed to be having difficulties not seen by the other major TAVR devices, Ballinger said: “The valve itself is performing well, the clinical results are very good, very favorable.”

Instead, he continued, it is “the sophistication and level of complexity of the mechanisms involved in the delivery system,” permitting operators to reposition and retrieve the valve as needed.

“This overarching design where the delivery system attaches to the valve, and you’re able to control each step of the procedure—that brings great things for Lotus in terms of physician control and function, but it’s proving to be a bit more challenging in terms of working through the final qualifications and verifications,” Ballinger explained.