Livanova’s mitral valve steams ahead, but could be a distant third to market


Livanova has completed the US feasibility study of its transcatheter mitral valve, Caisson, and can now switch its focus to the product’s European and US approval trials. The 20 patient feasibility study, Prelude (NCT02768402), aimed to demonstrate freedom from major adverse events including death, stroke, myocardial infarction and surgical reintervention at 30 days. Livanova did not explicitly state that this goal had been met, but said that “positive patient outcomes” had prompted it to move forward with the trial programme. Enrolment of 75 patients into Interlude, the European CE mark trial, is expected to be complete by 2020, suggesting potential 2021/2022 EU launch, according to Stifel analysts. It is further behind in the US; Ensemble, its trial for FDA approval, is still in the planning stages. Last month Abbott kicked off Summit, its 1,010-patient pivotal US trial of its mitral valve, and Medtronic started its equivalent, Apollo, in October. So far these are the only three companies with a path to the US market; Edwards Lifesciences’ mitral valve programme has gone silent since the phase I/II European approval trial Relief was paused in early 2017, and Boston Scientific is concerning itself with mitral repair, not replacement, technologies. Perhaps Livanova is lucky in that it is only on track to be third to market, not fifth.

Approval trials of transcatheter mitral valves
Company Valve Trial name Notes N Completion date Trial ID
Medtronic Intrepid - European approval trial 82 2018 -
Medtronic Intrepid Apollo US approval trial, part-randomised vs surgery  1,380 October 2021 NCT03242642
Abbott Laboratories Tendyne - Global trial with no control group, to be used for European approval 350 May 2018 NCT02321514
Abbott Laboratories Tendyne Summit US approval trial, part-randomised vs surgery  1,010 June 2022 NCT03433274
Livanova Caisson Interlude European approval trial  75 2021? -
Livanova Caisson Ensemble US approval trial; protocol being finalised  - - -

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