Medical Device Network

Paragonix heart transplant trial cuts graft dysfunction by half

The GUARDIAN-Heart trial consisted of 1,261 US adult patients and saw 32% drop in the use of post-transplant mechanical circulatory support.

US-based organ transplant company, Paragonix, has announced a trial of its SherpaPak organ preservation system saw a 50% reduction in severe primary graft dysfunction.

The results of the GUARDIAN-Heart trial also found that Paragonix’s SherpaPak, designed as an alternative method of organ transport as opposed to the traditional use of ice-boxes, also saw a 5% increase in two-year survival as well as a 43% reduction in two-year mortality.

The trial examined a total of 1,261 US adult patients. Along with other positive results, the heart transplant trial also saw a 44% reduction in severe right ventricular dysfunction (RVD) as well as a 32% drop in the use of post-transplant mechanical circulatory support in patients.

Scott Silvestry, cardiac surgeon and lead investigator of the study, said: “This breakthrough is game-changing. Previously when we started using SherpaPak, we were impressed how the donor hearts felt pliable and performed better immediately.

“Now, with evidence of superior survival two years after surgery, the average number of transplants required for a transplant centre to see an impact on the survival of their patients is only 22 procedures. We are now talking about saving lives and any given program can save one to five lives per year in the survival difference alone.”

Whilst the SherpaPak system is indicated for use with heart transplants, Paragonix has similarly seen success with its BAROguard Donor Lung Preservation System. Having already been granted US Food and Drug Administration (FDA) 510(k) clearance, Paragonix says it is the first commercially available hypothermic preservation system that can control the airway pressure of donor lungs automatically.

The findings were presented before the International Society for Heart and Lung Transplantation 2024 annual meeting.

Fellow lead investigator, David D’Alessandro, added: “For as long as heart transplant has been a discipline, we have been racing against the clock. This study indicates that the SherpaPak System can attenuate the risks of ischemic time through controlled hypothermic and isobaric preservation. Our findings showed that hearts performed better in a SherpaPak than on ice across all examined ischemic timeframes, whether it’s simply one hour or very long-distance procurements”

Elsewhere in the space of organ preservation, the US-based X Therma has secured $22.4m in funding to propel its XT-ViVo device to market.