Vygon Is Pumped for Partnership with Artificial Heart Maker

Two French medtech companies are working together to develop a vascular graft for an artificial heart.

Ecouen, France-based Vygon will develop and manufacture a vascular graft for the outflow tract of Carmat's Aeson artificial heart. Vygon plans to adapt its existing polythese vascular graft to make it compatible with Carmat's device. The company will develop the two prosthetic outflow tracts connecting the artificial heart device to the patient's pulmonary arteries and aorta.

Under the new agreement, Vygon also plans to develop a second bespoke device for Carmat by the fourth quarter of 2024.

Paris, France-based Carmat touts that its Aeson device is the world's first bioprosthetic artificial heart that is highly hemocompatible, pulsatile, and self-regulated. The device has a portable external power supply system, which is permanently connected to the implanted prosthesis.

Carmat's artificial heart is commercially available as a bridge to transplant device in the European Union and other countries that recognize CE marking. Aeson is also being assessed within the framework of an early feasibility study in the United States. The first U.S. implantation of the artificial heart as part of that study was performed in July 2021 at Duke University Hospital.

The study protocol approved by FDA calls for 10 transplant-eligible patients to be enrolled in the trial, with the primary endpoint being patient survival at 180 days post-implant. It is a staged study with a progress report of the first three patients after 60 days, before the enrollment of the next seven patients. Also in 2021, Carmat achieved the first commercial implant of its device in Europe.

Guillaume Puppinck, global director business plan and B2B deployment at Vygon, said the partnership with Carmat will enable Vygon to showcase one of its leading cardiovascular products.

“We’re excited to use our expertise to adapt our graft to Carmat’s requirements and play our part in developing a treatment solution for patients waiting for heart transplants,” Puppinck said.