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Paragonix Technologies Announces Commercial Availability of the FDA-cleared BAROguard™ Donor Lung Preservation System Nationwide

The innovative airway management device for donor lungs is now commercially available for use in clinical transplantation across the United States to promote maximum control over preservation conditions throughout procurement

BAROguard™ Donor Lung Preservation System

Paragonix Technologies, Inc., a pioneer in organ transplant technologies and procurement services, announces the full commercial launch of its next-generation transport device, the BAROguard ™ Donor Lung Preservation System. After an overwhelmingly positive response and demand during its limited market release, the technology is now available to transplant centers and Organ Procurement Organizations across the United States.

Clinically Proven Hypothermic Preservation Techniques

First-of-its-kind, the novel BAROguard system combines clinically proven hypothermic preservation techniques alongside active airway management control to ensure that donor lungs maintain optimal conditions during transport for maximum protection. Equipped with built-in tracking and real-time reporting, the device provides surgeons and transplant teams with continuous data on the organ’s condition throughout transit.

FDA Clearance Secured

Paragonix Technologies received FDA 510(k) clearance for the device in August 2023, and conducted its first-in-human case at Duke University Medical Center in November 2023. Throughout its limited market release, five of the country’s top thoracic transplant centers (Duke Health, Massachusetts General Hospital, Johns Hopkins Medicine, UCSF Health, UCLA Health) deployed the BAROguard System to safely place donor lungs for lung transplantation.

Dr. Nathaniel Langer, MD, MSC, Surgical Director, Lung Transplantation at Massachusetts General Hospital

“Traditional lung preservation does not provide transplant teams with any information about the actual conditions experienced by the organ. Unlike any other organ, lungs must hold air, so they are susceptible to damage from both over and under inflation during transport. The introduction of a device that both actively manages airway pressure and provides real-time data on internal temperature+- conditions during transport is an exciting advance that I hope will increase the availability of quality donor lungs to transplant programs around the country.”

The highly anticipated device launches in advance of the 44th ISHLT (International Society for Heart and Lung Transplantation) Annual Meeting and Scientific Sessions, where it is available for demonstrations at the Paragonix exhibit at the Prague Congress Centre in Prague, Czech Republic, from April 10th to April 13th. Attendees will have the opportunity to examine the new technology and hear from leading clinical experts who participated in the limited market release, such as Dr. Jasleen Kukreja, director of the Lung Transplant Program at UCSF Medical Center. Dr. Kukreja joins a panel of esteemed preservation experts on Friday, April 12th, to lead an industry symposium entitled “Reimagined Clinical Standards: Transformative Innovations in Organ Preservation,” which will feature research showcasing the impact of the BAROguard System’s active pressure control.

Dr. Lisa Anderson, CEO and President of Paragonix Technologies

“The commercial launch of BAROguard represents a significant breakthrough for the organ transplantation industry. We are immensely pleased with the success it has already achieved, and we are excited to offer this game-changing technology nationwide to help transplant surgeons and their teams to innovate the standard of care in transplantation.”

The valuable data collected from the commercial use of the BAROguard device will contribute to the renowned GUARDIAN-Lung study, a post-market observational registry intended to evaluate the clinical outcomes of patients who have donor lungs preserved with Paragonix lung preservation devices versus other storage methods.

Availability

The BAROguard System is available for clinical use across the United States. For more information about Paragonix Advanced Organ Preservation devices, please visit www.paragonix.com.

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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.

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