Respicardia, a US-based implantable therapies developer, has received approval from the US Food and Drug Administration (FDA) of an Investigational Device Exemption (IDE) to begin the pivotal trial of remedē System.
The trial will assess the safety and effectiveness of the remede System in patients with Central Sleep Apnea (CSA).
Edward Center for Advanced Heart Failure in Naperville medical director and principal investigator of the trial Maria Rosa Costanzo said that there is an unmet clinical need for effective solutions to treat patients with CSA.
"Previous studies have demonstrated statistically significant clinically meaningful improvements in sleep and respiration using the remede system and I am very excited to lead this very important trial," Costanzo added.
Respicardia plans for immediate enrollment of patients with moderate to severe CSA in its pivotal trial.
Respicardia president and CEO Bonnie Labosky said that the FDA approval to begin the pivotal trial marks a significant milestone for the company and is the next step on its path to improving the outcome for patients with CSA.
