This regulatory milestone marks a significant advancement both for XVIVO and for the broader field of heart transplantation, it states.

“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”.