DPS System for Breathing Support Approved by Feds
The NeuRx Diaphragm Pacing System (DPS) supports breathing for patients who are ventilator-dependent and is manufactured by Synapse Biomedical, Incorporated. The system recently received marketing clearance (pdf) from the Food and Drug Administration, as detailed in a press release from the Cleveland-based organization. The NeuRx is indicated for those patients with spinal cord injury (SCI) who are ventilator dependent and do not have voluntary control of their diaphragm.
The device is implanted during a minimally invasive laparoscopic surgery. The device provides electrical stimulation to the nerves and muscles that penetrate and traverse the diaphragm. Stimulation causes contraction of the diaphragm, which simulates natural breathing.
The system is controlled with a four-channel battery powered external pulse generator. The NeuRx does not require a separate power source. Patients, along with caregivers, can easily be taught how to operate the system.
The action of the NeuRx allows air to fill both the lower and upper parts of the lungs. This is distinct from the mechanism that air is received into the lungs through mechanical ventilation. Use of this system dramatically reduces the incidence of diseases that result from this means of support, such as ventilator acquired pneumonia.
Clinical data collected during pre-marketing studies indicates that 98 percent of patients who previously required full time mechanical ventilator support delivered through a tracheostomy were able to breathe normally with the NeuRx device implanted.
Patients also experienced improvements in their ability to live a more normal life. Examples of such include the chance to leave a ventilator ward and be transferred to an assisted living facility. Speech patterns returned to normal for some patients, which were previously strained and laborious.
Data collected thus far indicates that more than half the patients who had the device implanted no longer required mechanical support. The company notes that this product offers the opportunity to reduce healthcare costs while simultaneously improving breathing for patients with SCI.
June 18, 2008 Related topics: Critical Care, Product Approval & Certification, New Technology & Innovation, Monitoring