XVIVO receives CE certificates for its groundbreaking heart preservation technology, transforming access to life-saving transplants across Europe
XVIVO receives CE certificates for its groundbreaking heart preservation technology, transforming access to life-saving transplants across Europe
CAUTION—Investigational device in the US. Limited by Federal (United States) law to investigational use. The safety and effectiveness of this device have not been established. The XVIVO heart technology is not commercially available in the US.
XVIVO is proud to announce that its innovative heart preservation technology, XVIVO Heart Assist Transport system, has received CE certificates, making it available to any heart transplant center throughout Europe. This regulatory milestone marks a significant advancement both for XVIVO and for the broader field of heart transplantation.
Today, only three out of ten donated hearts are used for transplantation, often due to the limited time a donor heart can be preserved outside of the body. Additionally, early complications after transplantation often hinder long-term success. XVIVO Heart Assist Transport system directly addresses both challenges by safely extending preservation time and improving clinical results, enabling better donor-recipient matching, enhancing the efficiency of transplant programs, and ultimately improving patient outcomes.
Powered by hypothermic oxygenated perfusion (HOPE) — a novel method that actively preserves the heart in a controlled, oxygen-rich environment — 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.
The randomized controlled trial (NIHP2019), published in The Lancet, showed a 76 percent risk reduction in severe primary graft dysfunction (PGD) — a critical early predictor of long-term transplant success when HOPE was used. Additionally, 12-month follow-up data revealed a 38 percent risk reduction in severe complications, with a one-year survival rate of 92 percent in the XVIVO group compared to only 86 percent in the control group.
“This is a proud and defining moment for everyone at XVIVO”, says Christoffer Rosenblad, CEO of XVIVO. “Receiving CE certificates for our heart technology brings us one step closer to changing the paradigm of heart preservation. We are deeply grateful to the patients, clinicians, transplant teams and partners across Europe whose dedication helped make this possible. XVIVO Heart Assist Transport system is not just a technological breakthrough – it’s a symbol of hope for the thousands of patients waiting for a new heart”.
With CE certificates now in place, the XVIVO Heart Assist Transport system is immediately available for clinical use across Europe. This reinforces XVIVO’s commitment to advancing transplant medicine through science, innovation, and collaboration.
August 11, 2026
Gothenburg
Christoffer Rosenblad, CEO
XVIVO Perfusion AB (publ)