Within the framework of the PMI2023 call, Aferetica has launched the “SUPER” development program, aimed at advancing its electromedical system for ex vivo perfusion of organs intended for transplantation.
The program is structured along two main directions. The first focuses on upgrading the existing system, leading to the development of the new “PerLifeᴾᴿᴼ®” version. This upgrade introduces key features such as an automated organ rewarming protocol (from 4°C to 37°C), extended perfusion times of up to 24 hours, and compliance with the Medical Devices Regulation (EU) 2017/745 (MDR), along with improved performance and reliability.
In parallel, the program includes the development of the next-generation system, centered on greater integration and automation, as well as enhanced usability and design, to streamline and accelerate device preparation in clinical settings.
Project activities include clinical specification definition, hardware and software design, prototype development and validation, and optimization of manufacturing processes. Prototypes of the PerLifeᴾᴿᴼ® system and related disposable devices have already been completed, successfully tested, and integrated into the technical documentation.
The SUPER program also aims to develop a universal, integrated, and automated system for ex vivo perfusion of multiple organs – including kidney (also en-bloc), liver, and pancreas – introducing innovative solutions and industrialized processes for new electromedical and disposable configurations.
The project strengthens Aferetica’s position in the organ perfusion field, contributing to innovation in transplantation medicine and laying the groundwork for future developments of the PerLifeᴾᴿᴼ® system.
