Lungpacer Medical is set to accelerate the RESCUE 3 pivotal clinical study with the introduction of the AeroPace System.
The AeroPace System stimulates the nerves that activate the diaphragm by providing repetitive exercises to rebuild muscle strength and enable independent, natural breathing.
The RESCUE 3 clinical study is using the minimally invasive diaphragm strengthening technology developed by Lungpacer to examine faster ventilator independence.
It will evaluate the device’s safety and efficacy, which will assist in seeking approvals from the US Food and Drug Administration (FDA) and other international regulators.
According to an abstract presented at the 2021 American College of Chest Physicians Annual Conference, Covid-19 patients treated with Lungpacer therapy showed earlier liberation compared to mechanical ventilation.
The therapy was also demonstrated to strengthen the diaphragm 246% more, with 128% more improvement observed in lung function, according to findings from a previous Lungpacer clinical study.
Lungpacer CEO Doug Evans said: “The emerging research profile of AeroPace underscores the clinical potential of this therapy to play a meaningful role to limit the negative impacts of mechanical ventilation and restore strength for patients to achieve ventilator independence.
“Once approved, the AeroPace System has the potential to dramatically improve the standard of care and transform the future of ventilation.”
The company stated that the system works as a personal trainer for the diaphragm muscle.
The device offers an easy setup for patient therapy, as well as electrocardiogram (ECG)-guided catheter placement that helps to streamline clinical workload.
At present, more than 40 medical centres in France, Germany, Spain and the US are taking part in the Lungpacer therapy pivotal trial.