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EVAHEART®2 LVAS

Refractory NYHA Class IV Heart Failure (Bridge-to-Transplant or Destination Therapy)

Phase 3Active

Key Facts

Indication
Refractory NYHA Class IV Heart Failure (Bridge-to-Transplant or Destination Therapy)
Phase
Phase 3
Status
Active
Company

About EvaHeart

EvaHeart is a private medical device company developing the EVAHEART®2 Left Ventricular Assist System, a novel LVAD designed to provide gentle, high-flow circulatory support while retaining physiological pulsatility. The company is currently conducting the COMPETENCE trial, a large-scale, randomized study comparing its device to the market-leading HeartMate 3, aiming for FDA approval in the US. With its technology already approved and used clinically in Japan since 2010, EvaHeart is positioning itself as a potential competitor in the global advanced heart failure device market by addressing key complications associated with traditional LVADs, such as pump thrombosis and bleeding events.

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Therapeutic Areas