Synapse Biomedical’s TransAeris Deemed FDA Breakthrough Device

Synapse Biomedical has received a Breakthrough Device designation from the FDA for TransAeris, a diaphragm stimulator intended to help get patients off mechanical ventilation.

The temporary diaphragm stimulator is designed for patients who are at risk for prolonged mechanical ventilation, such as those undergoing high-risk open cardiac surgery, lung transplant or thoracoabdominal aortic aneurysm surgical procedures, the company said.

It is also intended for patients who have previously failed to get off mechanical ventilation or who have been have been on a ventilator for four days or longer to prevent or treat ventilator-induced diaphragm dysfunction.