Abstract
FDA approved the NeurX Diaphragm Pacing System developed and manufactured by Synapse Biomedical Inc late in September. It has now released further information on this recently approved device, in support of its release under Humanitarian Device Exemption rules. The approval is conditional upon Synapse undertaking a study of 60 patients.
Background
The company received CE Mark in November 2007, for treating patients with diaphragm dysfunction in the European Union. In June 2008 Synapse received FDA approval for the use of its NeuRx DPS™ for patients with spinal cord injury who can no longer breathe on their own. It has now extended potential; use of the device by receiving Humanitarian Device exemption for use in patients amyotrophic lateral sclerosis (ALS) patients with a stimulatable diaphragm (both right and left portions) as demonstrated by voluntary contraction or phrenic nerve conduction studies, and who are experiencing chronic hypoventilation (CH), but not progressed to an FVC less than 45% predicted. The device is indicated for use in patients 21 years of age or older.
The Device In Detail
The NeuRX Diaphragm Pacing System™ is an intramuscular, percutaneous, and motor point diaphragm stimulation system. It is implanted using standard laparoscopic surgical techniques in an outpatient procedure. The implanted intramuscular diaphragm electrodes are connected to a four channel external pulse generator at a percutaneous exit site. The pulse generator provides a capacitively coupled, charged balanced, biphasic stimulation to each electrode with a common indifferent electrode that is placed subcutaneously. The pulse generator controls the charge delivered through clinician programmed parameters of pulse amplitude, pulse duration, pulse frequency, pulse ramp, inspiration time, and respiratory rate. The clinician uses a clinical station to evaluate electrode response to stimulation and program the external pulse generator with the patient specific parameters. The user simply connects the device and turns it on for use; no other controls are available or necessary for operation.
How it works
The implanted intramuscular diaphragm electrodes are connected to a four channel external pulse generator at a percutaneous exit site. The pulse generator provides a capacitively coupled, charge balanced, biphasic stimulation to each electrode with a common indifferent electrode that is placed subcutaneously. The pulse generator controls the charge delivered through clinician programmed parameters of pulse amplitude, pulse duration, pulse frequency, pulse ramp, inspiration time, and respiratory rate. The clinician uses a clinical station to evaluate electrode response to stimulation and program the external pulse generator with the patient specific parameters. The user simply connects the device and turns it on for use; no other controls are available or necessary for operation.
Further details of FDA’s release can be found here.
Source: FDA, Synapse Biomedical Inc
published: November 28, 2011 in: Approval/Clearance, Neuro, Regulatory, Thoracic/Respiratory