Every Possible Advantage™
Paragonix SherpaPak® Cardiac Transport System
In the mission-critical world of transplantation, where there is no margin for error, Paragonix delivers the most advanced technologies to support transplant teams around the world every day.
Our flagship product, the Paragonix SherpaPak® Cardiac Transport System is also the only commercially available FDA-cleared and CE-marked medical device for heart transportation.
The Paragonix SherpaPak® CTS incorporates a novel nested canister system in concert with proprietary thermal cooling to provide unprecedented physical and thermal protection for donor hearts. All temperatures are monitored throughout the organ journey via a Bluetooth connected monitoring app.
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.
Controlled Temperature Range
No temperature gradients across donor hearts.
Fully Suspended and Immersed
Two rigid sterile canisters plus the SherpaPak shipper provide triple barrier protection of the heart.
Data Reporting and Monitoring
Continuously measures and displays temperature during storage and transport.
FDA Cleared and CE Marked Device
Use with any FDA-cleared, effective preservation solution indicated for donor heart.
GUARDIAN REGISTRY
Advancing the Science of Preservation
Paragonix is committed to improving the science and understanding of organ preservation and is leading the novel GUARDIAN Study to enhance understanding of the impact of advanced preservation.
The GUARDIAN Study is a post-market, observational registry containing both retrospectively and prospectively collected patient outcomes data. The GUARDIAN registry currently contains data from over 400 enrolled patients from 8 transplant centers.
Physicians from around the world are publishing their experiences with advanced preservation in clinical research journals.
Impact Multiple Stages of The Transplant Process
Figures represent the percentage difference observed between transplant recipients of donor hearts preserved by Paragonix SherpaPak® CTS and ice storage, as reported in the GUARDIAN registry. These results are based on analysis of the first 223 patients (99 ice transports and 124 Paragonix SherpaPak CTS transports) enrolled in GUARDIAN across 5 transplant centers.
POST TRANSPLANT
*Numerical trend, does not achieve statistically significance, p=0.062 **Numerical trend, does not achieve statistically significance, p=0.071
New Procurement Consensus
New consensus statement from the International Society for Heart and Lung Transplantation calls for strategies to avoid close proximity to ice because of irreversible cellular damage and graft failure.3
Paragonix SherpaPak® CTS helps users confirm achievement of ISHLT Donor Heart and Lung Procurement Consensus Statement preservation goals:- Physically & thermally isolate with rigid, sterile container
- Temperature maintenance at above freezing risk point
- Measure and record to confirm correct storage
Delivering Life to the Smallest of Patients
Paragonix SherpaPak® Cardiac Transport System (CTS), is now cleared by the FDA to be used with small and pediatric donor hearts.
Heart connectors covering most aortic diameters, are provided with the Paragonix SherpaPak® Cardiac Transport System, permitting the anchoring of various size hearts.
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