Five of Paragonix Technologies‘ devices have now received European Union (EU) Medical Device Regulation approval, the company announced.

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.

Paragonix claims the MDR approvals solidify 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 offering new possibilities in organ transplantation.

Paragonix organ preservation devices are cleared by the U.S. Food and Drug Administration (FDA) and have been used in more than 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 used at over 40 transplant centers in EU under previous CE-Mark status, and at more than 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 regulatory-compliant medical devices,” Paragonix Technologies President Dr. Lisa Anderson stated. “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.”

Paragonix Technologies is a 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. Its 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 the company’s digital app, delivering real-time organ tracking data and monitoring logistics for transplant teams seeking a secure and centralized solution.

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