Stimdia Medical announced today that it received FDA breakthrough device designation for its pdSTIM system.
Minneapolis-based Stimdia’s pdSTIM system is designed to offer a tool in addressing high-risk patients, including those with COVID-19, by providing a minimally invasive neurostimulation solution to awaken and recondition the diaphragm, according to a news release.
The platform facilitates the weaning of patients suffering from ventilator-induced diaphragmatic dysfunction (VIDD) who are on mechanical ventilation for 96 hours or more and who have failed at least two weaning attempts.
Stimdia’s pdSTIM system is currently offered for investigational use only and is not for sale in any country.
“Receiving FDA breakthrough device designation for the pdSTIM system will help prioritize the process for obtaining regulatory authorization in the U.S.,” Stimdia Medical GM Tim Miller said in the release. “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.”