GUARDIAN-Lung Registry

		Ice (n=259)	Paragonix LUNGguard (n=259)	p-value
PGD	PGD 3 at 24 hours	20.5%	12.7%	0.024
	PGD 3 at 72 hours	15.4%	9.7%	0.063
Post-Transplant MCS	ECMO Post-Transplant	18.9%	11.6%	0.027
Renal Function	Dialysis at Discharge	11.2%	5.5%	0.025
	Renal Dysfunction at Discharge	30.6%	18.0%	<0.001

Latest Results from the GUARDIAN-Lung Registry

Largest Real-World Multi-Center Study Outcomes Reported with Controlled Hypothermic Preservation of Donor Lungs

[.c-text-4]J. Haney, M. Hartwig, N. Langer, P. Sanchez, P. Carrott, H. Huang, L. Ceulemans, J. Kukreja, E. Bush[.c-text-4]
[.c-text-4] ISHLT 2024 Presentation[.c-text-4]

The results of an extensive clinical study presented at the 44th ISHLT Annual Meeting and Scientific Sessions comparing conventional ice storage to the Paragonix LUNGguard system. The analysis revealed that advanced lung preservation technology with the Paragonix LUNGguard favorably influences post-transplant outcomes, including reductions in primary graft dysfunction, the use of invasive MCS interventions, and improvement in renal function.

The GUARDIAN-Lung data was collected from August 2018 through January 2024, including 797 patients (389 ice storage patients, 408 LUNGguard patients), of which 259 subjects were identified as statistical matches based on a propensity matching methodology.

Investigators discovered notable statistically significant improvements in the controlled hypothermic preservation group, including:

• 38% reduction of Primary Graft Dysfunction 3 (PGD 3) at 24 hours (12.7% LUNGguard vs. 20.5% Ice, p = 0.024)¹
• 39% reduction of Extracorporeal Membrane Oxygenation (ECMO) post-transplant (11.6% LUNGguard vs. 18.9% Ice, p = 0.027)¹
• 51% reduction in need for dialysis at discharge (5.5% LUNGguard vs. 11.2% Ice, p = 0.025)¹‍

Further, a numerical reduction in primary graft dysfunction at 72 hours, an indication of severe post-transplant complications, was also observed in the LUNGguard group (9.7% LUNGguard vs. 15.4% Ice, p = 0.063).¹

[.c-text-4]1) Haney et al., ISHLT Presentation 2024, Data on file[.c-text-4]

See more initial GUARDIAN-Lung results

Comparison of Paragonix LUNGguard to Ice Storage, Paragonix data on file. GUARDIAN is a registered clinical study (NCT04930289) funded and administered by Paragonix Technologies. The data from the registry is descriptive, not statistically powered, and not pre-specified. The information should be interpreted accordingly.

-37%

PGD 3 at 72 hours

p value = 0.063 (trending)

-39%

ECMO

p value = 0.027

Post-Transplant

-51%

Dialysis at discharge

p value = 0.025

-41%

Renal dysfunction at discharge

p value = <0.001

No items found.

Request more information about the GUARDIAN clinical registries

First name*

Last name*

Job title

Organization

Country

Message

Paragonix Technologies is committed to protecting and respecting your privacy, and we’ll only use your personal information to administer your account and to provide the products and services you requested from us. From time to time, we would like to contact you about our products and services, as well as other content that may be of interest to you. If you consent to us contacting you for this purpose, please check the appropriate box below. You can unsubscribe from these communications at any time. For more information on our privacy practices, and how we are committed to protecting and respecting your privacy, please review our Privacy Policy.

I agree to receive communications relating to this request from Paragonix Technologies.*

I would like to receive important product updates and Marketing offers.

By clicking submit below, you consent to allow Paragonix Technologies to store and process the personal information submitted above to provide you the content requested.

Thank you! Your submission has been received!

Oops! Something went wrong while submitting the form.

GUARDIAN-Lung Registry

Clinical Results