FDA Grants Humanitarian Use Device Designation for Diaphragm Pacing System in ALS

Yael Waknine

October 14, 2010

October 14, 2010 — The US Food and Drug Administration (FDA) has granted humanitarian use device designation for a diaphragm pacing system (NeuRx; Synapse Biomedical, Inc) in patients with amyotrophic lateral sclerosis (ALS) who have a stimulatable diaphragm and who are experiencing chronic hypoventilation.

ALS, also known as Lou Gehrig's disease, is a progressive neurodegenerative disease characterized by increasing muscle weakness that particularly affects the arms and legs, speech, swallowing, and breathing. As paralysis progresses, the phrenic nerve to the diaphragm fails and patients lose the ability to breathe without ventilator support.

The pacing system consists of a 4-channel battery-operated external pulse generator with 4 electrodes that are laparoscopically implanted into the diaphragm muscle during an outpatient procedure. External pulse generator stimulation causes the diaphragm muscles to contract in a manner that mimics natural respiration, potentially delaying diaphragm atrophy and the need for mechanical ventilation.

The device was previously cleared by the FDA in October 2005 for use as an investigational device at 8 clinical trial sites in the United States, and the company hopes to continue enrolling patients in ALS studies.

"In our efforts to help people with this devastating disease, we are using and focusing every available resource to help advance the availability of the NeuRx treatment. Having obtained [humanitarian use device] designation and filed our [humanitarian device exemption] application for ALS, we will now seek Continued Access approval for our clinical trial centers," said Anthony R. Ignagni, Synapse president and chief executive officer, in a company news release.

Continued Access is an Office of Device Evaluation policy that allows clinical trial sponsors to continue enrolling patients while a marketing application is under review. It is granted based on public health need for the device or preliminary evidence of safety and efficacy in its proposed use.

The diaphragm pacing system previously was granted a humanitarian device exemption by the FDA for use in patients with spinal cord injuries. It also is approved for treating patients in the European Union with diaphragm dysfunction.

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