Livanova blows a valve

The smash hit Coapt study of Abbott Laboratories’ MitraClip mitral valve repair device has had far-reaching consequences, and not just for Abbott. So impressive was the device’s performance that the standard of care for mitral valve disease has changed, and this is the reason cited by Stifel analysts for Livanova’s decision to can development of Caisson, its prosthetic mitral valve. Livanova had acquired the device’s maker for $72m in 2017, presumably in an attempt to revive flagging sales at its valves business – a decline that is forecast to continue, according to EvaluateMedTech consensus. The group is restructuring its entire valve offering in a bid to boost profitability and eliminate overlap between production facilities. The 75 patients in Caisson’s European approval trial, Interlude, will continue to be followed for ethical reasons but the company said that “higher regulatory requirements” were one of the factors contributing to the restructuring; perhaps it believes the single-arm study would not be good enough to obtain CE mark. The shift will allow Livanova to prioritise faster growing areas, like treatment-resistant depression. Its Symmetry vagus nerve stimulator is in a trial called Recover in 1,000 refractory depression patients, aimed at obtaining Medicare coverage.

LivaNova
  WW annual sales ($m)  
Segment 2019 2024 CAGR
Heart-lung machines 204 241 +3%
Oxygenators 388 442 +3%
Autotransfusion machines and devices 91 82 -2%
Mechanical heart valves 39 31 -4%
Tissue heart valves 99 94 -1%
Other heart valves 9 9 -1%
Advanced circulatory support 44 91 +16%
     Cardiac surgery total 873 991 +3%
Refractory epilepsy 516 777 +9%
Treatment-resistant depression 1 1 +9%
     Neuromodulation total 516 778 +9%
Medtech sales 1,389 1,769 +5%
     Total company revenues 1,392 1,771 +5%
Note: Caisson is classed as a tissue valve. Source: EvaluateMedTech.

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