BAROguard Advanced Lung Preservation System

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The vanguard of Paragonix active control systems

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Automated management of lung airway pressure

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Uphold critical variables to clinical recommendations¹

The Forefront of Lung Transportation

Building on the legacy of its predecessors, the BAROguard system is the first commercially available hypothermic preservation system that is equipped to automatically calibrate the airway pressure of donor lungs during transportation. This leading-edge device incorporates a never-before-seen pressure system that actively maintains the donor lungs at an appropriate and consistent level of inflation pressure, regardless of external, fluctuating variables such as ambient pressures, ambient temperatures, or surgical recovery techniques.

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Caution: Federal (US) law restricts this device to sale by or on the order of a licensed health care practitioner. Please refer to Instructions for Use for full prescribing information. Cleared indication is for 8 hour use. Patents issued and pending. See legal page for more information.

Active Pressure Control

According to a 2020 consensus statement on donor heart and lung procurement, The International Society for Heart and Lung Transplantation recommends that explanted donor lungs should be inflated at a static pressure of 12-15 cm of water pressure (cm H₂0). Traditionally, surgical recovery techniques are unable to monitor or control inflation, potentially exposing the lungs to suboptimal pressures outside the clinically recommended range. It has been shown that both over- and underinflation may risk damage to the donor lungs during transport.

The BAROguard system is the first – and only – preservation device capable of adjusting the inflation pressure to the clinically recommended range, regardless of ambient pressures. The device actively monitors for fluctuations in pressure, then automatically adjusts to an appropriate level and relays real-time metrics directly to the Paragonix app.

Technological Advantage of Advanced Organ Preservation

Traditional Ice Storage

Uses commercial-grade coolers unregulated by the FDA
Exposes the the donor lung(s) to an unmonitored environment of 0°C ice
Lung tissue is exposed to uneven cooling, potentially risking freezing injury
Unpredictable temperature reductions within the ice cooler are not monitored during transport
Unmonitored pressure fluctuations risk trauma associated with over- or under-inflation of donor lungs

Paragonix BAROguard

An FDA-cleared preservation device intended to actively protect and monitor donor lung(s) in transit
Validated to maintain a consistent thermal environment for 40 hours
Utilizes SherpaCool™ phase-change technology to prevent exposure to excessive temperature reduction
Automates management of donor lungs’ airway pressure throughout the journey for unprecedented control
Records temperature, pressure, location, and case status in real-time

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Merging industry-leading preservation technology with an integrated pressure control system

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

Active Airway Pressure Control

Automated system actively maintains pressure at ISHLT recommended range of 12-15 cm H2O relative to environment

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

Advancing the Science of Preservation

The GUARDIAN-Lung clinical registry is a post-market, observational registry of lung transplant recipient patients whose donor lung was preserved and transported using the Paragonix LUNGguard™ Donor Lung Preservation System, or the Paragonix BAROguard Donor Lung Preservation System. Our panel of clinical investigators analyze the post-transplant outcomes of Paragonix advanced lung preservation technologies in comparison to traditional ice storage. 

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 BAROguard™ (BAROguard) is intended to be used for the static hypothermic preservation of lungs during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with the lungs. The intended organ storage time for BAROguard™ is up to 8 hours. Donor lungs 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. 

Note: Partial lungs can be transported via BAROguard by packaging lungs per institutional protocol and UNOS guidelines.

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