MARLBOROUGH, MA — Final testing of the Lotus aortic valve and its delivery system has identified issues that will delay the Lotus Edge relaunch in Europe and premarket approval (PMA) submission in the US, Boston Scientific has announced.
All Lotus valves were voluntarily recalled in February because of reports of early release of a pin connecting the transcatheter valve to the delivery system, but expectations were that they would resurface possibly by year's end.
"Unfortunately, while completing final product testing required for regulatory submissions, we did encounter some unexpected validation challenges, which will require additional attention," and thus "we will be unable to meet our prior timeline guidance for US PMA filing by January 2018 and European relaunch by first quarter of 2018," Boston Scientific chairperson and chief executive officer Mike Mahoney said during an investors' call today.
Boston Scientific president of interventional cardiology Kevin Ballinger said that a recent update showed that "the valve design itself is performing well; the clinical results are very good, very favorable" and that the company has been able to resolve the early pin release issue.
"It's not that issue per se, but I would say in general it is still part of that kind of overarching umbrella of how the valve attaches to the delivery system and then how the delivery system controls each step of the procedure," he added.
Asked why the Lotus valve design has been so difficult compared with other transcatheter aortic valves, Ballinger said, "The sophistication and level of complexity of the mechanisms that are involved in the delivery system yield the enhanced functionality of the Lotus, namely the respositionability and retrievability, but they do also in all honesty provide a level of challenge and a level of design elements in Lotus that other products might not see."
Market projections for 2018 were offered during the call both with and without the Lotus valve, prompting questions about whether the company might eliminate the Lotus program and focus instead on the Acurate Neo valve (Boston Scientific/Symetis), which received CE mark in Europe in 2014 but remains investigational in the US.
"It's certainly not our intention," Ballinger said. "Our dual-valve strategy we think is the right strategy. We've talked a lot about how these two valves certainly position themselves in a complementary fashion. So our intention and focus right now is working day and night through these issues."
He noted that the second half of 2018 is a "realistic target" to start a US trial of the Acurate Neo device and that the company hopes to have investigational device exemption (IDE) status by then as well.
The company also expects to provide an update on the status of the Lotus Edge valve during its fourth quarter 2017 earnings conference call February 1, 2018.
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Cite this: Lotus Valve Hits New Snag, Delaying Rollout Plans - Medscape - Nov 29, 2017.