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.
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Delivering a New Standard in Heart Preservation & Transport
Paragonix SherpaPak® Cardiac Transport System has preserved over 800 hearts since start of clinical use in 2018. The leading FDA cleared and CE marked preservation device for heart transportation, Paragonix SherpaPak CTS provides a sterile, temperature and pressure-controlled environment for organs traveling between operating rooms. This award-winning product is designed to be easy-to-use in stressful, clinically demanding environments where there is no room for mistakes.
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.
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Donor Hearts Preserved
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Transplant Centers
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Clinical Publications
New ISHLT Procurement Consensus
New consensus statement from ISHLT calls for strategies to avoid close proximity to ice because of irreversible cellular damage and graft failure.1
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
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.
Physicians from around the world are publishing their experiences with advanced preservation in clinical research journals.
Advanced Preservation. Advanced Care.
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
1-YEAR SURVIVAL
+8.7%
1-year Survival
P value = 0.03
PGD
-37%
PGD*
P value = 0.10
SEVERE PGD
-72%
Severe PGD
P value = 0.005
POST TRANSPLANT
MCS
-39%
All Post-Tx MCS
P value = 0.03
IABP
-66%
Newly Placed IABP
P value = 0.02
ECMO/VAD
-60%
Newly Placed ECMO/VAD
P value = 0.02
Comparison of Paragonix SherpaPak to Ice Storage, Paragonix data on file. GUARDIAN is a registered clinical study (NCT04141605) funded and administered by Paragonix Technologies. At the time of this analysis, GUARDIAN contained data from 17 sites on 849 patients (384 ice transports and 465 Paragonix SherpaPak CTS transports). The data from the registry is descriptive, not statistically powered, and not pre-specified. The information should be interpreted accordingly. In this analysis, US adult cohorts were matched using statistical propensity matching to create cohorts of equal baseline characteristics (149 ice transports and 149 Paragonix SherpPak CTS transports) with a matching propensity score allowable difference of 0.025.
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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:
1. 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.
1. Donor heart and lung procurement: A consensus statement. Copeland et al.
2. D’Alessandro et al., The Journal of Heart and Lung Transplantation 2021, Volume 40, Issue 4, Supplement , S127, April 01, 2021
*Numerical trend, does not achieve statistically significance, p=0.10
