The pdSTIMTM System is indicated for mechanically ventilated adults at least 22 years old suffering from diaphragmatic dysfunction who have been on mechanical ventilation for ≥ 96 hours and have failed at least one weaning attempt.
The pdSTIM System is intended to increase diaphragmatic strength and facilitate weaning via temporary stimulation of the phrenic nerve. The System:
- Uses small percutaneous leads positioned adjacent to each of the patient’s phrenic nerves for delivery of electrical stimulus.
- Stimulates the phrenic nerve and coordinates movement of the diaphragm in concert with mechanical ventilation to ensure the diaphragm works physiologically to deliver normal levels of work during a specified breath.
- Utilizes Stimdia Medical’s proprietary sensing and stimulation algorithms to coordinate phrenic nerve stimulaton with physiologic movement of the diaphragm.
The pdSTIM System exercises the diaphragm. It does not ventilate the patient. Phrenic nerve stimulation is performed in synchrony with mechanical ventilation.
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pdSTIM™ System Components
The pdSTIM System is comprised of several components which work together to coordinate phrenic nerve stimulation and physiologic diaphragmatic movement for patients on mechanical ventilation.
Therapy Set-up and Implementation
pdSTIM Leads are designed to enable minimally invasive placement at a patient’s bedside in an ICU setting. The leads, which are placed percutaneously in the neck region, represent the world’s smallest multielectrode lead (2.6 Fr) and fit through a needle enabling “through the needle” insertion. The pdSTIM Leads do not require placement via the vasculature nor near/within any organs. Since lead placement is not in the vasculature nor near/within any organs, there is a reduced risk of placement related complications and infections. The placement location also prevents interference with other lines or leads a patient may have.
Once the leads are placed and connected to the console, phrenic nerve stimulation is coordinated via the proprietary RespiSyncTM algorithm to produce physiologic diaphragmatic movement. The pdSTIM System is agnostic to the type or mode of ventilator.