Stimdia Medical has secured breakthrough device designation from the US Food and Drug Administration (FDA) for its pdSTIM system, which is designed to facilitate weaning patients from mechanical ventilation.

According to the company, the pdSTIM system offers temporary stimulation to facilitate weaning from mechanical ventilation in patients who have been on mechanical ventilation for 96 hours or more and who are at risk of having difficulty in weaning.

The system will serve as a tool for clinicians to address high-risk patients, including those with Covid-19.

The pdSTIM system will help provide a minimally invasive neurostimulation solution to recondition the diaphragm, the primary muscle utilised in respiration.

Stimdia’s pdSTIM system will allow to electrically stimulate the phrenic nerves in a patient’s neck to exercise the diaphragm during mechanical ventilation to minimise ventilator-induced diaphragmatic dysfunction (VIDD) and facilitate weaning.

To enable coordination of phrenic nerve stimulation with physiologic diaphragmatic movement, the system uses the company’s advanced RespiSync sensing and stimulation algorithms.

Stimdia Medical general manager Tim Miller said: “Receiving FDA Breakthrough Device Designation for the pdSTIM System will help prioritize the process for obtaining regulatory authorization in the U.S.

“Over 40% of ICU admissions in the U.S. require mechanical ventilation with an average length of stay of 14 days for ventilated patients and an estimated annual cost of over $27 billion.

“We believe the pdSTIM System will help to reduce both length of stay and costs by enabling more rapid weaning of patients from mechanical ventilators.”

Stimdia stated that the pdSTIM system is currently for investigational use only and is not for sale in any country.