Stimdia Medical, Inc., is a privately held company headquartered in Minneapolis, MN and has developed the pdSTIMTM System, a minimally invasive, temporary, neuromuscular stimulation system which has received FDA Breakthrough Device Designation.
Mechanical ventilation (MV) is considered to be a lifesaving treatment in patients suffering respiratory failure to achieve sufficient pulmonary gas exchange. However, prolonged MV can promote atrophy and contractile dysfunction of the primary muscle utilized in respiration, the diaphragm. Significant loss in muscle mass results in a reduction in diaphragmatic function and compromises the ability of patients to breath on their own.
The pdSTIM System was designed to awaken and restore the integrity of the diaphragm muscle in patients who are on MV. This is accomplished with the use of subcutaneously inserted temporary leads connected to the pdSTIM console and utilizes the proprietary RespiSyncTM sensing and stimulation algorithms to coordinate phrenic nerve stimulation with physiologic diaphragmatic movement in synchrony with mechanical ventilators.
The pdSTIM System has not yet received regulatory clearances or approvals and is not currently for sale in any country.
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