Addressing the Risks of Donor Liver Preservation

Protect

Prevent physical and thermal trauma

Control

Move on from ice and unpredictable results

Standardize

A repeatable and measurable process

Addressing the Risks of Cold Ischemia Time

Cold ischemia time refers to the period of time during which a donor liver is cooled to maintain its viability until it can be transplanted into the recipient. The length of cold ischemia time may vary greatly, although prolonged cold ischemia time is traditionally associated with greater risk of complications after the transplant procedure. Research has linked longer cold ischemia times with poor outcomes, such as longer post-transplant hospital stays and a higher rate of primary graft nonfunction.^1,2
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Traditionally, donor livers destined for transplantation were placed into commercial-grade coolers filled with ice to transport it to the recipient. This method presents a multitude of uncontrolled variables that can also impact the function of the liver post-transplant. Clinical evidence has shown that the use of ice can expose donor organs to freezing temperatures, leading to irreversible cellular damage.³

The Paragonix LIVERguard is an Advanced Organ Preservation device specifically designed to standardize the variables of donor liver preservation, providing physicians with stable cooling technology driven by real-time data monitoring.

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Caution: Federal (US) law restricts this device to sale by or in the order of a licensed health care practitioner. Please refer to Instructions for Use for full prescribing information. Cleared indication is for 15-hour use. Patents issued and pending. See Indications For Use for more information.

Technological Advantage of Advanced Organ Preservation

Traditional Ice Storage

Uses commercial-grade coolers unregulated by the FDA
Exposes the the donor liver to an unmonitored environment of 0°C ice
Liver tissue is exposed to uneven cooling, potentially risking freezing injury
Unpredictable temperature reductions within the ice cooler are not monitored during transport

Paragonix LIVERguard

An FDA-cleared and CE-marked preservation device intended to protect the donor liver in transit
Validated to maintain a consistent thermal environment for 40 hours
Utilizes SherpaCool™ phase-change technology to prevent exposure to excessive temperature reduction
Records temperature, location, and case status in real-time

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Rigid Outer Shell

Protective polystyrene material ensures internal environment will maintain temperature over 40 hours

SherpaCool Technology

Proprietary phase-change cooling formula that maintains optimal temperature conditions without the use of 0°C ice

Triple Bag System

Industry-standard, best-in-class bagging system

Temperature Probe

Embedded probe continuously monitors and records the internal and ambient temperatures

Monitor and Data Transmission

Simple Bluetooth® pairing allows the system to transmit full data reports to as many users as necessary

Multi-Center Clinical Research

To measure the clinical impact of advanced liver preservation, Paragonix leads the novel GUARDIAN-Liver Clinical Registry. Our panel of clinical investigators analyze the post-transplant outcomes of the LIVERguard in comparison to traditional ice storage.
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The GUARDIAN-Liver study is a post-market, observational registry of adult liver transplant recipient patients whose donor liver was preserved and transported using the Paragonix LIVERguard™ Donor Liver Preservation System. The data is being collected retrospectively from medical records of patients already transplanted before the initiation of the registry and any new patients who meet the eligibility criteria.

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Follow your transplant’s journey from beginning to end

The Paragonix App and Web Portal allows transplant teams to coordinate case logistics in a centralized, secure platform designed specifically for use in a real-world setting. And, if greater logistical support is needed, you can rely on our network of experienced personnel to expand your surgical coverage.

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Or, Learn More About Our Organ Procurement Services

Important Safety Information

Indications for Use

The Paragonix LIVERguard™ Donor Liver Transport System is intended to be used for the static hypothermic preservation of livers during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with donor livers.The intended organ storage time for the LIVERguard™ system is up to 15 hours.
Donor livers exceeding clinically accepted static hypothermic preservation times should be evaluated by the transplant surgeon to determine transplantability in accordance with accepted clinical guidelines and in the best medical interest of the intended recipient.
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Note: A partial liver can be transported via the LIVERguard™ System by packaging liver per institutional protocol and UNOS guidelines.

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