Where We Are

Development & Validation

UniFlow is in the prototype and preclinical validation phase. This page summarizes what has been done, what is in progress, and what is planned next.

Roadmap

Development stage

  1. Concept & Design

    Device architecture defined; design intent and engineering targets established.

    Complete

  2. Computational Validation (CFD)

    Computational fluid dynamics studies completed to evaluate flow behavior in patient-relevant geometries.

    Complete

  3. In-Vitro Validation

    Bench testing in flow-loop setups underway to characterize hydraulic performance and durability.

    In Progress

  4. Preclinical Studies

    Device-anatomy interaction studies and preclinical evaluation in preparation.

    Planned

  5. Regulatory & Clinical Pathway

    Engagement with regulatory pathways and clinical investigation planning.

    Planned

Current Work

What we're studying

Axial-view illustration of a circulatory support impeller within a stent cage. A generic example, not the actual UniFlow geometry.
Illustrative example of a catheter-based circulatory support device. Not the actual UniFlow design, which will be shown after patent approval.

Computational Fluid Dynamics

Flow simulations across patient-relevant cavopulmonary geometries to characterize pressure, velocity, and shear stress profiles. Used to inform device geometry and operating envelope.

In-Vitro Flow-Loop Testing

Bench rigs reproducing single-ventricle hemodynamics, used to characterize hydraulic performance, pulsatility behavior, and prototype durability under physiologically representative conditions.

Device-Anatomy Interaction

Patient-specific anatomical models in preparation, supporting future in-silico and preclinical testing of device fit and behavior across anatomical variability.

No clinical data is available at this stage. UniFlow is not approved for clinical use.