Spinal cord injury (SCI) occurs when there is any damage to the spinal cord that blocks communication between the brain and the body. It can be caused by trauma (diving, auto accidents, falls, surgical procedure, etc.), viral infections, diseases (Arnold-Chiari syndrome, tumors, etc.). If the injury is at levels of C1-C3, respiratory failure occurs. The patient needs to be breathing with the help of a mechanical ventilator which pumps air into the lungs or be implanted with a breathing pacemaker that contracts the diaphragm similar to the natural breathing.
Below are the only two surgical options for SCI:
|Criteria||Avery Biomedical Devices||Synapse Biomedical|
|FDA Approval||Full PMA (pre-market approval)||Only HDE (Humanitary Device Exemption)|
|Years of experience||>49 years||2 years|
|Long-term pacing safety||Well documented.||Unknown|
|Risk of infections||Implanted device. No open wounds.||Wires protrude through the skin. Wound care for life is required (minimum every 3 days). Cannot take showers or baths while pacing.|
|Risk of failure||If one side fails, the other side still contracts the diaphragm.||If device fails, patient cannot breathe.|
|Approved for all ages||Pediatric and adults.||Adults only (18 years or older).|
At Avery Biomedical Devices, we are committed to helping those with breathing difficulties and improving the quality of life. If you have any questions regarding the Avery Diaphragm Pacemaker System and the specific benefits of choosing the system, please call us at 631-864-1600 or contact us to request more information. We are here to help you!