A New Standard in Donor Heart Preservation

Over 4k

Donor hearts preserved

Over 120

Transplant centers

Over 40

Clinical publications

Delivering a New Standard in Heart Preservation

Traditionally, donor hearts 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 impact the function of the heart post-transplant. Clinical evidence has shown that ice transport can expose the donor heart to freezing temperatures, leading to irreversible cellular damage.^1
‍
The Paragonix SherpaPak CTS is an Advanced Organ Preservation device specifically designed to standardize the variables of donor heart 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 an the order of a licensed health care practitioner. Please refer to Instructions for Use for full prescribing information. Cleared indication is for 4 hour use. Patents issued and pending. See legal page for more information.

Technological Advantage of Advanced Organ Preservation

Traditional Ice Storage

Uses commercial-grade coolers unregulated by the FDA
Packs heart in layered plastic bags filled with cold liquid solution
Exposes cold liquid solutions - and the donor heart - to an environment of 0°C ice
Unpredictable temperature reductions within the ice cooler are not monitored during transport

SherpaPak CTS

An FDA-cleared and CE-marked preservation device intended to protect the donor heart in transit
Suspends heart in an isolated, pressure-controlled canister of cold liquid solution
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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Offering a controlled approach designed for ease-of-use in a clinical setting.

Temperature Probe

Internal probe continuously monitors and records the internal and ambient temperatures

Heart Connector

Interchangeable heart connector fully suspend adult and pediatric hearts in cold preservation solution

Nested Canister System

Pressure-controlled, leak-proof rigid canister safeguards and cools the heart evenly

SherpaCool Technology

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

Rigid Outer Shell

Protective polystyrene material ensures internal environment will maintain temperature

Monitor and Data Transmission

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

Clinical Findings and Research

To measure the clinical impact of advanced organ preservation, Paragonix leads the novel GUARDIAN-Heart Clinical Registry. Our panel of clinical investigators analyze the post-transplant outcomes of the SherpaPak CTS in comparison to traditional ice storage.
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A 1-year propensity-matched analysis was recently published in 2022, showcasing that the transplant recipients in the SherpaPak CTS cohort experienced more positive outcomes than those in the traditional ice storage cohort.^2,3

Discover the Clinical Impact

+5%

2-year Survival

p value = 0.04

-39%

All mechanical circulatory support

p value = 0.03

Post transplant

-37%

Primary graft dysfunction

p value = 0.10

-66%

Newly placed intra-aortic balloon pump

p value = 0.02

Post transplant

-72%

Severe primary graft dysfunction

p value = 0.005

-60%

Newly placed extracorporeal membrane oxygenation / ventricular assist device

p value = 0.02

Post transplant

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.

Learn More About Our Digital Services

Or, Learn More About Our Organ Procurement Services

Important Safety Information

Indications for Use

The Paragonix SherpaPak® Cardiac Transport System is intended to be used for the static hypothermic preservation of hearts during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with the heart. The intended organ storage time for the Paragonix SherpaPak Cardiac Transport System is up to 4 hours. Donor hearts 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.

Contraindications

The Paragonix SherpaPak Cardiac Transport System should not be used in the following circumstances: When safe connection with the aorta cannot be made, e.g., due to lack of enough length of the aortic root.

Caution: Donor hearts exceeding 4 hours static hypothermic preservation time will require transplant surgeon evaluation to determine transplantability.

Request more information about our contributions to advancing donor organ transplantation.

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