FDA clears new heart preservation system for transplants
The U.S. Food and Drug Administration (FDA) has cleared the X°Port Heart Preservation System from Ontario-based Traferox Technologies. The new device offers static 50 degrees F (10 degrees C) heart preservation during transport prior to transplantation, which has been shown in studies to improve outcomes.
Peer-reviewed evidence has linked 10 degrees C heart preservation to reductions in severe primary graft dysfunction and improved post-transplant survival compared to conventional ice storage and exposure to hypothermic temperatures. Improved outcomes were also seen involving transplants of higher-risk donor hearts.[1,2]
“The strong clinical evidence supporting 10 degrees C heart preservation, together with the successful adoption of 10 degrees C preservation across leading lung transplant programs, has demonstrated the potential of this approach to improve donor organ preservation and transport," Rick Mangat, PhD, chief executive officer of Traferox, said in a statement. "We look forward to working with transplant centers across the US to support the continued adoption of 10 degrees C preservation in routine clinical practice."
The FDA indication for the device is for static hypothermic preservation of donor hearts at 4 to 10 degrees C for up to four hours using a del Nido (or equivalent) cold storage solution.
The U.S. regulatory clearance comes as clinical evidence supporting 10°C heart preservation continues to grow. There has been a push to move away from hypothermic temperatures using ice to transport organs in an effort to better preserve hearts, which are more sensitive to to temperature and time outside the body than other explanted organs like kidneys.
Vanderbilt University Medical Center was the first U.S. institution to investigate 10 degrees C heart preservation clinically, building on the success of its 10 degrees C preservation in lung transplantation. As the largest heart transplant center in the U.S., Vanderbilt has completed more than 150 organ transfers using 10 degrees C preservation.
“Ten degrees C preservation has changed how we approach donor heart preservation,” Ashish Shah, MD, professor of cardiac surgery and surgical director of the heart transplant program at Vanderbilt, said in the same statement. “It is the standard in our institution for performing heart transplantation.”
The approval of the X°Port Heart system comes after the 2025 U.S. launch of the company's X°Port Lung device. The company said it has been adopted by seven of the 10 highest-volume U.S. lung transplant centers, and is now used in more than half of all lung transplant programs in the U.S.
Traferox was founded in 2021 as a spin-off company from the University Health Network’s Toronto General Hospital.
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: [email protected]