The European Union (EU) has approved an integrate system comprising PerLife ex vivo organ perfusion system from Aferetica and ECOS-300CY sorbent cartridge from CytoSorbents, to remove inflammatory mediators during ex vivo organ perfusion.

CytoSorbents is a medical devices company engaged in research, development and commercialisation of its blood purification technology platform.

Aferetica is focused on blood purification, therapeutic apheresis, and solid organ perfusion as an alternative to expensive drugs and invasive systems.

The integrated system is said to enhance the preservation and quality of solid organs, including kidneys and liver, after harvest and before transplant into a new recipient.

Both the companies have worked towards the mutual compatibility of their technologies and are expected to commercially launch the PerLife System and PerSorb adsorber in Italy this quarter.

Aferetica chief executive officer Mauro Atti said: “With the creation of PerLife and its EU certification, we are now entering the commercial phase for organ perfusion and real-world clinical usage.

“This follows five years of development and fine-tuning, including a fruitful three-year partnership with CytoSorbents to develop and integrate a new sorbent technology that can help to purify, clean, and preserve solid organs collected for transplant.

“Early studies conducted by some of the most prestigious Italian universities have demonstrated the vast potential of this combined system for organ transplant.”

PerLife is an advanced therapeutic system for organ transplant

PerLife is an advanced, integrated, therapeutic system designed for organ transplant. It is claimed to be the first system to offer both perfusion and purification of the kidney and the liver, following organ retrieval and before organ implantation.

The platform is said to integrate latest patented and advanced technologies, to cover a broad range of temperature preservation techniques.

The CytoSorbents ECOS-300CY perfusion cartridge helps the system remove inflammatory mediators, which could affect the health and quality of the organs.

The integrated therapy system is aimed at supporting the solid organ transplants by preserving good organs, rehabilitating sub-optimal ones, and enhancing the overall viable organs.

The PerLife platform and ECOS-300CY PerSorb cartridge are capable of changing how organs are treated before transplant, said the company.

CytoSorbents president and chief operating officer Vincent Capponi said: “We are thrilled to collaborate with Aferetica as they prepare to enter the Italian market. The Italian market performs approximately 3,600 transplants per year with 6,000 patients on the waiting list, representing about 10% of the European market.

“The ECOS-300CY cartridge will be included as part of the PerLife perfusion kit as the ‘PerSorb’ cartridge.  We believe that organ preservation and reconditioning is a key to increase organ availability.

“The lack of adequate oxygenation, the unavailability of nutrients, and the presence of inflammatory mediators can cause organ damage with consequent post-transplant complications. The feature-rich PerLife System has the ability to take ex vivo organ perfusion to a new level, particularly when combined with the seamlessly integrated ECOS-300CY “PerSorb” cartridge.”