VisONE System
Phase 2- Indications
- Heart failure with reduced ejection fraction
Company intelligence / Profile preview
Preclinical and First-in-Human trials have demonstrated safety of the implant procedure and proprietary SDS/ADS therapy. Early feasibility studies showed improvements in acute hemodynamic parameters and chronic left ventricular ejection fraction without adverse effects. The company has received FDA IDE approval for a pivotal randomized controlled trial ("RECOVER HF") to further evaluate efficacy. In May 2025, the company was honored with a major innovation award at EuroPCR for its disruptive approach to heart failure management.
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