Medical Device News

FDA Clears LUNGguard for Donor Lung Preservation System

Paragonix Technologies Claims LUNGguard Safeguards Lungs Between Donor and Recipient Patients

About Medical Device News Magazine

About Medical Device News Magazine. We are a digital publication founded in 2008 located in the United States.

Advertise with Medical Device News Magazine! Join Our #1 Family of Advertisers!

We pride ourselves on being the best-kept secret when it comes to distributing your news! Our unique digital approach enables us to circulate your...

Paragonix announced clearance of a Pre-Marketing Notification (510(k)) with the US Food and Drug Administration (FDA) for its Donor Lung Preservation System – LUNGguard1,2.

The Paragonix LUNGguard Donor Lung Preservation System 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 LUNGguard 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.3

LUNGguard is designed to function with ease in the often extremely stressful, fast-paced environments of donor and transplant centers. The current standard-of-care for donor lungs is to package the lungs in a series of sterile bags placed on crushed ice without the ability to maintain, monitor and report environmental conditions of the organ. LUNGguard is designed to overcome current preservation limitations and provide reporting of preservation and transport data. LUNGguard will be commercially available to all US lung transplant centers in Q2 of 2020.

“Donor lungs for transplant are fragile, precious cargo that are by necessity packaged and transported over great distances. Quality management and control over the environmental conditions of the donor lung is critical to the success of the operation,” commented Matthew Hartwig, MD, lung transplant surgeon at Duke University Lung Transplant Program. “We are looking forward to evaluating this innovative technology in clinical practice and implementing additional quality management over the donor lung transport process using LUNGguard.”

“Patients on the lung transplant waitlist must be given every possible advantage in their journey of becoming a lung transplant recipient,” commented Jeff Goldstein, CEO of the Lung Transplant Foundation. “Based on my own experience as a lung transplant recipient, technologies are critically needed that support and complement the incredible clinical effort afforded by surgical teams and Organ Procurement Organizations as well as the wonderful gift from a donor family.”

“The recent addition of LUNGguard to our expanding portfolio of organ preservation devices serving all solid organs will provide an important tool for the transplant community,” said Bill Edelman, Chairman and CEO of Paragonix Technologies. “We are thrilled to contribute to improved lung preservation with LUNGguard.”


References

1On January 16, 2020, FDA cleared for commercial distribution the SherpaPak™ Lung Preservation System 510(k) pre-market submission.
2Patents pending.
3Partial lungs can be transported via the LUNGguard Donor Lung Preservation Device by packaging lungs per institutional protocol and UNOS guidelines.
4Thorac Dis. 2010 Jun; 2(2): 111–116.
5Orphanet J Rare Dis. 2008; 3: 8.
6https://www.who.int/respiratory/copd/burden/en/
7https://optn.transplant.hrsa.gov/data/view-data-reports/national-data/
8https://www.transplants.org/faq/how-much-does-transplant-cost
9Milliman Research Report, “2014 US Organ and Tissue Transplant Cost Estimates and Discussion”

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine provides breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

Other News

Ultrahuman Announces its App Store ‘PowerPlugs’ with the World’s First AFib Detection Technology on a Smart Ring

Recognizing each individual’s health journey is unique, PowerPlugs enable people to choose and focus on the aspects of their health that matter most. It’s designed for highly personalized health insights, ensuring that every individual can personalize their health tracking to their unique needs and goals.

VisionAir Solutions Celebrates Milestone and New Collaboration

This achievement marks VisionAir Solutions commitment to bringing technological innovation to pulmonary medicine. Since its acquisition by Theken Companies last year, VAS has over doubled its growth and continues to demonstrate industry adoption and the advantages of personalized healthcare.

Valencia Technologies Announces CMS Publication of 2025 Medicare Proposed Rule for eCoin® Procedure

Ann Decker, VP of Reimbursement for Valencia Technologies, stated, "The cumulative effect of the proposed 2025 continuation of APC assignment 5464, the improved ASC payment rate, and the recognition of ITNS as a minimally invasive OAB treatment option in the recently updated guidelines by the American Urological Association (AUA) and the Society of Urodynamics, Female Pelvic Medicine, and Urogenital Reconstruction (SUFU), underscores that the eCoin ITNS system will have a strong reimbursement pathway throughout 2025 and beyond.