Regulatory Milestone Expands Access to Advanced Transplant Technologies Across Europe
Paragonix Technologies, a pioneer in organ transplant technologies and organ procurement services, announced today that five of its devices have now received approval under the European Union (EU) Medical Device Regulation 2017/745, commonly referred to as EU MDR. This approval further confirms Paragonix's compliance with the highest quality control standards for medical devices and allows continued access to the European market under the new EU regulations.
The EU MDR sets quality standards for medical devices sold in the European Union, with an emphasis on safety, risk management and post-market surveillance. It replaces the former Medical Device Directive 93/42/EEC (MDD), introducing a more stringent framework and heightened requirements for market approval in Europe.
With this approval, Paragonix solidifies its position as a global leader in organ preservation and transplant innovation. The approval includes five products developed to modernize donor organ preservation and transport: the Paragonix SherpaPak® for heart preservation, BAROguard® and LUNGguard® for lung preservation, PancreasPak® for pancreas preservation, and LIVERguard® for liver preservation. Each device is designed to enhance the safety, viability and efficiency of organ transport. By reinventing the standard of care through its advanced technology, Paragonix is paving the way for new possibilities in organ transplantation worldwide.
Paragonix organ preservation devices are FDA cleared and have been used in over 10,000 transplant cases globally since the introduction of the Paragonix SherpaPak Cardiac Transport System in 2018. The Paragonix SherpaPak and LUNGguard systems are now utilized at over 40 transplant centers in EU under previous CE-Mark status, and at over 150 transplant centers globally. Paragonix cardiothoracic devices have been shown in multiple clinical studies to reduce post-transplant complications (SherpaPak, LUNGguard) as well as safely extend ischemic times (SherpaPak, LUNGguard) allowing transplant centers more access to donor organs, and give more patients a chance at a second life.
"Receiving this approval marks a significant milestone for Paragonix and Getinge, reinforcing our commitment to delivering innovative and regulatory-compliant medical devices," said Dr. Lisa Anderson, President of Paragonix Technologies. "This achievement validates our technology's safety and effectiveness while expanding our ability to serve patients and healthcare providers in critical transplant care across the world. With this approval and the support structure provided by Sweden-based Getinge, we are dedicated to setting new standards in organ preservation, advancing the future of transplantation, and making a global impact."
For more information about Paragonix Advanced Organ Preservation devices, please visit www.paragonix.com.
About Paragonix Technologies
Paragonix Technologies is a leading developer, manufacturer, and service provider in the organ transplant industry, establishing a novel approach to organ preservation. Paragonix Technologies provides Advanced Organ Preservation ("AOP") devices that safeguard donor organs during the journey between donor and recipient patients. Our FDA-cleared and CE-marked devices incorporate clinically proven and medically trusted cold preservation techniques that allow unprecedented physical and thermal protection to the organ during transit. All Paragonix AOP devices are natively integrated with our novel digital app, delivering real-time organ tracking data and monitoring logistics for transplant teams seeking a secure and centralized solution. For more information, visit www.paragonix.com.
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References
- D'Alessandro et al. Impact of controlled hypothermic preservation on outcomes following heart transplantation. JHLT 2024
- Moayedifar et al. Recipient Outcomes With Extended Criteria Donors Using Advanced Heart Preservation: An Analysis of the GUARDIAN-Heart Registry. JHLT 2024
- Ceulemans et al. Controlled Hypothermic Storage for Lung Preservation: Leaving the Ice Age Behind. Frontiers Transplant Int. 2024
- Ceulemans et al. Extended ischemic time (>15 hours) using controlled hypothermic storage in lung transplantation: A multicenter experience. JHLT 2024
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Contacts:
Paragonix Media: Adam Lafreniere, Vice President, Marketing
marketing@paragonixtechnologies.com
