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.
Paragonix SherpaPak® Cardiac Transport System has preserved over 800 hearts since start of clinical use in 2018. Currently the only 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.
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:
GUARDIAN REGISTRY
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.
Waitlist Days
P value = 0.0095
Total Ischemic Time
P value = 0.0003
Cardioversion*
P value = 0.062
POST TRANSPLANT
Severe PGD**
P value = 0.071
ICU Days
P value = 0.009
LVEF (Heart Output)
P value = 0.032
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.
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
CONTACT
Paragonix Technologies, Inc
222 Third Street
Suite 2242
Cambridge, Massachusetts 02142
info@paragonixtechnologies.com
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