Synapse Biomedical announced that it has completed the enrollment of the post-approval study of its NeuRx DPS System for ALS patients.
The last patient needed to meet the FDA enrollment requirement was implanted over a month and a half ahead of schedule. The NeuRx DPS, which is the only medical device approved by the FDA specifically for ALS patients, is a humanitarian device that obtained approval at the end of 2011 with the demonstration of safety and probable benefit.
This post-approval study, validating the safety, is also intended to help identify the patient population that may benefit most from this therapy.
"When we see the impact that this device can have for individual patients, we know that providing this supporting therapy is meaningful for ALS patients", said Anthony Ignagni, President and Chief Executive Officer.
NeuRx Diaphragm Pacing System (DPS) is a four-channel, battery-powered neurostimulator with implanted electrodes. The device provides electrical stimulation to the muscle and nerves of the diaphragm.
The NeuRx DPS received CE Marking (CE Registration #518356) on November 20, 2007 and is approved for treating patients with diaphragm dysfunction in the European Union.
The NeuRx DPS received FDA approval for ventilator dependency from spinal cord injury on June 17, 2008. In Spinal Cord Injury (SCI), the NeuRx DPS® provides ventilatory support in patients with diaphragm dysfunction of neuromuscular origin.
Diaphragm dysfunction can result in abnormal or absent respiration in patient populations of high-level spinal cord injury and other injuries or diseases affecting the neuromuscular respiratory pathways.
The NeuRx DPS received FDA approval for treating chronic hypoventilation from ALS on September 28, 2011. The NeuRx DPS has demonstrated that it can help people with ALS live longer and sleep better than the current standard of care, alone.