France-based Synapse Biomedical has obtained the Health Canada approval for its NeuRx diaphragm pacing system (DPS) for ventilator-dependent spinal cord injury (SCI) patients who lack voluntary control of their diaphragms.
Synapse Biomedical’s NeuRx DPS provides ventilatory support in patients with diaphragm dysfunction of neuromuscular origin.
Health Canada approved the NeuRx DPS based on the positive outcome from the clinical trials conducted at hospitals in the US and Canada, including the Vancouver General Hospital.
Implanted through minimally invasive laparoscopic surgery, this device provides electrical stimulation of the muscles of the diaphragm.
When stimulated by the NeuRx DPS, the diaphragm contracts, mimicking natural breathing, and allows air to fill the upper and lower parts of the lungs rather than forcing air in with a mechanical ventilator.
In November 2007, Synapse Biomedical has obtained CE Mark approval for the NeuRx DPS system and is approved for treating patients with diaphragm dysfunction in the EU.
In June 2008, the device obtained the US Food and Drug Administration approval for ventilator dependency from spinal cord injury.
Synapse Biomedical CEO Anthony R Ignagni said: "We are pleased Health Canada has given approval to NeuRx DPS so we can now offer individuals throughout Canada the ability to breathe on their own."
The Health Canada approval allows the company to implant the NeuRx DPS system in all spinal cord injury patients in Canada.