Rachel Klemovitch06.22.23
French medtech company Vygon plans to develop and manufacture a vascular graft for the outflow tract of Carmat’s Aeson artificial heart.
Vygon will develop two prosthetic outflow tracts that connect the artificial heart device to the patient’s pulmonary arteries and aorta. With this new partnership, Vygron plans to adopt its existing polythese vascular graft to make it compatible with Carmat’s device as well as plans to develop a second bespoke device by the fourth quarter of 2024.
Carmat claims its Aeson device is the world’s first highly hemocompatible, pulsatile, and self-regulated bioprosthetic artificial heart. The device contains a permanently connected portable external power supply system.
Carmat’s Aeson is currently commercially available in the European Union and other counties as a bridge to transplant device. The device is also being assessed in the United States in an early feasibility study. The first implementation of the Aeson device was part of a study performed in July 2021 at Duke University Hospital. Also in 2021, the first commercial implant of the device occurred in Europe.
The FDA approved protocol calls for 10 transplant-eligible patients to be enrolled in the trial, with the primary endpoint of patient survival at 180 days post-implant. Since it’s a staged study, a progress report occurs for the first three patient after 60, before the enrollment of the next seven patients.
Guillaume Puppinck, global direct business plan at Vygon said, “we’re excited to use our expertise to adapt out graft to Carmat’s requirements and play our part in developing a treatment solution for patients waiting for heart transplants.”
Vygon will develop two prosthetic outflow tracts that connect the artificial heart device to the patient’s pulmonary arteries and aorta. With this new partnership, Vygron plans to adopt its existing polythese vascular graft to make it compatible with Carmat’s device as well as plans to develop a second bespoke device by the fourth quarter of 2024.
Carmat claims its Aeson device is the world’s first highly hemocompatible, pulsatile, and self-regulated bioprosthetic artificial heart. The device contains a permanently connected portable external power supply system.
Carmat’s Aeson is currently commercially available in the European Union and other counties as a bridge to transplant device. The device is also being assessed in the United States in an early feasibility study. The first implementation of the Aeson device was part of a study performed in July 2021 at Duke University Hospital. Also in 2021, the first commercial implant of the device occurred in Europe.
The FDA approved protocol calls for 10 transplant-eligible patients to be enrolled in the trial, with the primary endpoint of patient survival at 180 days post-implant. Since it’s a staged study, a progress report occurs for the first three patient after 60, before the enrollment of the next seven patients.
Guillaume Puppinck, global direct business plan at Vygon said, “we’re excited to use our expertise to adapt out graft to Carmat’s requirements and play our part in developing a treatment solution for patients waiting for heart transplants.”