VP.S ENCORE® · Premarket Cardiac Perfusion System

The heart deserves more than cold storage.

VP.S ENCORE® is a bloodless hypothermic machine perfusion system designed to extend donor heart viability up to eight hours — using FDA-approved perfusate, passive cooling, and familiar, standardized materials.

FDA Breakthrough Bloodless Passive Cooling Premarket
• 01

Four stages. One continuous window.

VP.S ENCORE® operates as a closed, bloodless circuit — primed at recovery, perfused continuously through transport, and ready to deliver the organ directly into the operating room.

01 · Prime

Prime

The circuit is primed with FDA-approved perfusate at the recovery site — no blood, no blood products, no specialty reagents.

02 · Perfuse

Perfuse

Continuous hypothermic machine perfusion begins immediately, limiting ischemic injury from the moment of cross-clamp.

03 · Transport

Transport

Passive cooling and long-life battery support a portable, single-person unit through standard transport — ground or air.

04 · Transplant

Transplant

The organ arrives ready to transition into the operative field, with a built-in cold storage fallback if circulation is interrupted.

• 02

Built on familiar materials.
Engineered to disappear.

Operating Mode
Hypothermic Machine Perfusion
Perfusate
FDA-approved · Bloodless · No blood products
Cooling
Passive — no active refrigeration loop
Run Time
Up to 8 hours of continuous perfusion
Handling
Single-person setup and transport
Power
Long-life battery + mains backup
Fallback
Built-in cold storage mode on interruption
Materials
Familiar, standardized components
Regulatory
FDA Breakthrough Device Designation · Premarket
• 03

Rigorously tested. Peer-reviewed.

Preclinical100+Heart perfusions completed.
Window8hrsTarget viability window.
Blood Products0Required for operation.

VP.S ENCORE® has undergone extensive preclinical evaluation — including more than 100 heart perfusions — and has received FDA Breakthrough Device Designation. Peer-reviewed publications and ongoing research continue to refine the science of bloodless hypothermic machine perfusion.

The simplest system that solves the hardest problem is usually the one that scales.

Browse publications
• 04

Simple. Portable. Reliable.

Three design principles at the heart of VP.S ENCORE® — each earned through the preclinical program, not assumed.

01 · Simple

A deliberately spare circuit.

Familiar, standardized materials mean setup fits inside existing recovery protocols — no new specialty training, no new reagents, no new failure modes.

02 · Portable

Single-person handling.

Long-life battery, no specialty transport, no additional retrieval-team headcount. Passive cooling means nothing to manage mid-flight.

03 · Reliable

Built-in fallback.

A cold-storage fallback protects the organ if circulation is interrupted — maintaining hypothermic conditions while minimizing ischemic risk.

• 05

Frequently asked.

Is VP.S ENCORE® FDA approved?

VP.S ENCORE® is an investigational device, currently in development and not yet approved for commercial use by the FDA. It has received FDA Breakthrough Device Designation, which accelerates development and review for technologies that address unmet medical needs.

Does it require blood or blood products?

No. VP.S ENCORE® operates bloodlessly, using FDA-approved perfusate and passive cooling — eliminating the supply-chain, cross-match, and infection-control overhead of blood-based systems.

How long does it extend heart preservation?

VP.S ENCORE® is designed to extend donor heart viability up to eight hours, compared to the approximately four-hour ceiling of standard cold storage.

Who operates the device in the field?

The system is engineered for single-person handling. Familiar, standardized materials and a simplified circuit reduce the training and staffing burden on retrieval teams.

What happens if circulation is interrupted mid-transport?

A built-in cold storage fallback automatically maintains hypothermic conditions on the organ — minimizing ischemic risk while the team addresses the interruption.

• 06 · Schedule a Demo

Ready to see VP.S ENCORE® in person?

Connect with our team for a live walkthrough of the system, the circuit, and the preclinical data behind it.