On August 11, 2026, XVIVO Perfusion announced that its Heart Assist Transport system received CE certificates for use across Europe, a regulatory milestone that allows transplant centers to adopt a new method for preserving donor hearts during transport. The approval marks a shift from static ice storage to active, oxygenated perfusion, giving surgeons more time to match organs with recipients and expanding access to life saving transplants.
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What the CE mark means for transplant centers
The CE mark indicates that a medical device meets European Union safety, health, and environmental protection requirements. With CE certificates in place, the XVIVO Heart Assist Transport system is immediately available for clinical use at any heart transplant center throughout Europe. Hospitals can now integrate the technology into their procurement and transport protocols without waiting for national approvals.
[biospace](https://www.biospace.com/press-releases/xvivo-receives-ce-certificates-for-its-groundbreaking-heart-preservation-technology-transforming-access-to-life-saving-transplants-across-europe)
For transplant teams, the approval removes a major barrier. Under the previous framework, centers could only use the system under special access schemes or within clinical trials. The CE certification validates the device under the EU Medical Device Regulation, confirming that it has passed rigorous testing for electrical, mechanical, and environmental safety, as well as electromagnetic compatibility and software risk management.
[forcetechnology](https://forcetechnology.com/en/cases/xvivo-heart-tech-global-approvals-iec-60601)
How the Heart Assist Transport system works
The XVIVO Heart Assist Transport system uses hypothermic oxygenated perfusion, known as HOPE, to preserve donor hearts in a controlled, oxygen rich environment. Instead of placing the heart on ice, the device continuously circulates a cold, oxygenated solution through the organ, maintaining cellular function and reducing injury during transport.
[biospace](https://www.biospace.com/press-releases/xvivo-receives-ce-certificates-for-its-groundbreaking-heart-preservation-technology-transforming-access-to-life-saving-transplants-across-europe)
This approach addresses two core challenges in heart transplantation. First, it safely extends preservation time beyond the limits of traditional cold storage, which typically allows only a few hours before tissue damage becomes significant. Second, it improves clinical outcomes by keeping the heart in a more physiologic state, which can reduce complications after implantation.
[finance.yahoo](https://finance.yahoo.com/healthcare/articles/xvivo-receives-ce-certificates-groundbreaking-115000101.html?fr=sycsrp_catchall)
The system is designed for portability. The Heart Assist Transport unit is compact enough to travel with the organ by road or air, allowing coordination between distant donor hospitals and recipient centers. That flexibility is critical when matching rare blood types or when recipients are located far from the donor site.
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Why this matters for patients and waitlists
Heart transplant waitlists remain long, and many donor organs are discarded because they cannot be transported in time or do not meet strict criteria under ice storage. By extending the viable preservation window, the XVIVO system gives transplant teams more time to evaluate organ quality, perform additional testing, and arrange logistics without rushing.
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Better preservation also means more organs can be used. Hearts that might have been declined under traditional methods may become viable when perfused with oxygenated solution. For patients, that translates into shorter wait times and a higher chance of receiving a suitable organ.
[finance.yahoo](https://finance.yahoo.com/healthcare/articles/xvivo-receives-ce-certificates-groundbreaking-115000101.html?fr=sycsrp_catchall)
Clinical evidence supports the benefit. The XVIVO Heart Assist Transport system is the first heart technology of its kind to demonstrate superiority in clinical trials over traditional ice storage, the current standard of care for preservation of donor hearts. That data formed a key part of the regulatory submission and gives centers confidence in adopting the new method.
[biospace](https://www.biospace.com/press-releases/xvivo-receives-ce-certificates-for-its-groundbreaking-heart-preservation-technology-transforming-access-to-life-saving-transplants-across-europe)
Regulatory path and remaining components
The CE certificates cover the XVIVO Heart Assist Transport device and the XVIVO Heart Assist Transport Perfusion Set. These components form the core of the system and are sufficient for clinical use with existing perfusion solutions in some settings.
[xvivogroup](https://www.xvivogroup.com/pressreleases/delay-in-ce-approval-for-xvivos-perfusion-solution-for-heart-preservation/)
Approval for XVIVO’s proprietary heart perfusion solution and supplement is still pending. Because the solution is classified differently under EU rules, the notified body must seek a scientific opinion from the European Medicines Agency and another EU competent authority before issuing the CE certificate. XVIVO estimates this consultation process will take approximately 6 to 12 months, depending on submission slot times and additional information requests.
[xvivogroup](https://www.xvivogroup.com/pressreleases/delay-in-ce-approval-for-xvivos-perfusion-solution-for-heart-preservation/)
In the interim, centers can use the device with approved solutions or under local protocols while awaiting full system clearance. The company has indicated that the main components of the heart technology have reached CE mark, even as the solution review continues.
[xvivogroup](https://www.xvivogroup.com/pressreleases/delay-in-ce-approval-for-xvivos-perfusion-solution-for-heart-preservation/)
How this fits into the broader organ preservation landscape
XVIVO is not alone in modernizing organ preservation. Paragonix Technologies received EU MDR approval in March 2025 for five organ preservation devices, including the SherpaPak system for heart preservation, which is already used at more than 40 transplant centers in the EU and over 150 globally. These systems use controlled temperature transport rather than active perfusion, offering a different approach to extending organ viability.
[paragonixtechnologies](https://www.paragonixtechnologies.com/news/paragonix-secures-eu-mdr-approval-for-five-organ-preservation-devices)
The emergence of multiple technologies signals a broader shift in transplant medicine. Centers are moving away from static ice storage toward methods that actively maintain organ function. This trend is visible in kidney and liver transplantation as well, where machine perfusion has gained traction over the past decade.
[xvivogroup](https://www.xvivogroup.com/wp-content/uploads/2024/04/xvivo-perfusion-ab-publ-annual-report-2023.pdf)
For regulators, the challenge is to ensure that new devices meet high safety standards without slowing innovation. The XVIVO approval process included comprehensive testing for electrical and mechanical safety, electromagnetic compatibility, acoustical testing for alarm systems, and evaluation of software, usability, and risk management documentation. Compliance with international standards such as IEC 60601 series and ISO 13485 underpins the CE mark.
[forcetechnology](https://forcetechnology.com/en/cases/xvivo-heart-tech-global-approvals-iec-60601)
What transplant teams should consider now
Hospitals evaluating the XVIVO Heart Assist Transport system should start with a review of current procurement and transport workflows. Integrating active perfusion requires training for surgical teams, coordination with organ procurement organizations, and updates to transport logistics. Early adopters may need to invest in equipment, consumables, and staff education.
[forcetechnology](https://forcetechnology.com/en/cases/xvivo-heart-tech-global-approvals-iec-60601)
Centers should also assess clinical protocols. The extended preservation window allows more flexibility in scheduling surgeries and performing recipient optimization. Some programs may choose to use the technology for marginal donor hearts that would otherwise be declined, while others may apply it routinely to all transports to standardize care.
[finance.yahoo](https://finance.yahoo.com/healthcare/articles/xvivo-receives-ce-certificates-groundbreaking-115000101.html?fr=sycsrp_catchall)
For detailed information on the device and its regulatory status, the XVIVO Group press release provides an overview of the CE certificates and the company’s contact information for clinical inquiries.
[biospace](https://www.biospace.com/press-releases/xvivo-receives-ce-certificates-for-its-groundbreaking-heart-preservation-technology-transforming-access-to-life-saving-transplants-across-europe)
Implications for patients and families
If you or a loved one is on a heart transplant waitlist, this development may improve your options. More viable organs and longer preservation times mean that transplant centers can consider a wider range of donors and coordinate across greater distances. That can reduce wait times and increase the likelihood of receiving a suitable heart.
[finance.yahoo](https://finance.yahoo.com/healthcare/articles/xvivo-receives-ce-certificates-groundbreaking-115000101.html?fr=sycsrp_catchall)
Ask your transplant team whether they plan to adopt active perfusion technologies and how that might affect your care. Some centers may begin using the XVIVO system immediately, while others may wait for full system clearance, including the perfusion solution. Understanding your center’s approach can help you set realistic expectations.
[xvivogroup](https://www.xvivogroup.com/pressreleases/delay-in-ce-approval-for-xvivos-perfusion-solution-for-heart-preservation/)
What to watch in the coming months
The next milestone will be CE approval for the XVIVO heart perfusion solution and supplement. Once that component is cleared, the system will be fully integrated under a single regulatory framework, simplifying procurement and use across Europe.
[xvivogroup](https://www.xvivogroup.com/pressreleases/delay-in-ce-approval-for-xvivos-perfusion-solution-for-heart-preservation/)
Clinical adoption will also be a key indicator. As more centers publish outcomes using the XVIVO Heart Assist Transport system, the transplant community will gain clearer data on survival rates, complication profiles, and cost effectiveness. That evidence will shape guidelines and reimbursement decisions.
[finance.yahoo](https://finance.yahoo.com/healthcare/articles/xvivo-receives-ce-certificates-groundbreaking-115000101.html?fr=sycsrp_catchall)
The European CE mark for XVIVO’s heart preservation technology is a significant step forward for transplant medicine. By enabling active, oxygenated perfusion of donor hearts, the system extends preservation times, improves organ utilization, and expands access to life saving transplants. For patients waiting for a new heart, the approval brings tangible hope that more organs will reach them in time and in better condition.
