Organ transplant storage technology company Paragonix has announced the successful completion of the GUARDIAN-Heart trial in the US. The trial aimed to determine if the SherpaPak Cardiac Transport System technology was superior to existing ice-box transplant storage solutions for donor hearts that are currently on the market. Traditional ice-box devices rely on bags of ice to refrigerate donor hearts, but the SherpaPak utilises a pressurised canister with a cold liquid solution to preserve the organ with significantly fewer uncontrolled variables than other devices.
Surgeons dealing with donor hearts face several challenges due to ice-box storage, some of which are caused by temperature fluctuation or contact with the ice itself. These challenges can result in severe problems for heart transplant or heart graft patients, which can compromise long-term survival and create additional issues, such as ventricular dysfunction or reliance on circulatory support post-procedure. The trial of the SherpaPak demonstrates that more advanced organ preservation equipment, especially for cardiac operations, is ideal compared to traditional ice-box preservation. Researchers found that the use of the SherpaPak led to a 43% reduction in two-year mortality and a 5% increase in two-year survival. There was a significant reduction in right ventricular dysfunction and the usage of post-operative circulatory support.
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According to the GlobalData marketed products database, there are a total of 50 medical devices currently on the market indicated for organ transplant procedures and organ storage, including cardiac transplants. A further 38 devices are currently in development or clinical trials, according to the GlobalData pipeline products database. This market segment is growing quickly and is likely to innovate further as devices such as the SherpaPak receive additional clinical backing and certification.
The SherpaPak and similar devices hope to reduce the burden on healthcare systems caused by the nature of transporting donor organs, including hearts. With the greater control over transport variables afforded to physicians by the device, as evidenced by the GUARDIAN-Heart trial, post-operative complications from donor hearts can probably be reduced and patient outcomes improved.
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