Synapse snaps up full FDA approval for diaphragm stimulation system

Synapse snaps up full FDA approval for diaphragm stimulation system

More than a decade after it first became available to help patients hospitalized with spinal cord injuries breathe more naturally than they can with a ventilator, Synapse Biomedical’s diaphragm pacing system is, fittingly enough, picking up the pace.

The NeuRx system has received premarket approval from the FDA, Synapse announced Wednesday, making it available to more patients with spinal cord injuries who need help breathing.

The system previously earned a humanitarian device exemption from the FDA in 2008. The exemption encompasses devices that target conditions affecting a maximum of 8,000 U.S. patients per year; applying for the exemption allows devicemakers to skip over typical FDA clearance requirements regarding efficacy data for a particular device.

But while its designation as a humanitarian use device allowed NeuRx to be sold in the U.S. starting in 2008, those sales were limited by the FDA, which allows devicemakers to profit only from a certain number of devices per year—calculated by multiplying the number of the devices typically needed to treat an individual per year by 8,000. Additionally, only hospitals that have undergone an internal review and approval process may implement humanitarian use devices.

“With this FDA approval, we can make our diaphragm pacer available to many more patients who were previously unable to access a hospital administering our humanitarian device,” Anthony Ignagni, CEO and founder of Synapse, said in the announcement.

The NeuRx system comprises a set of electrodes, an electrical pulse generator and a controller for the entire mechanism, which delivers negative-pressure ventilation that Synapse says more closely mimics the natural breathing cycle than standard ventilators.

To start, during a minimally invasive laparoscopic procedure, a surgeon places four electrodes in the diaphragm plus a fifth under the skin. All five electrodes connect to the battery-powered pulse generator, which sends electrical signals to the muscles and phrenic nerve of the diaphragm that tell it to contract. Those signals can be adjusted by the patient’s doctor using the “clinical station” controller, based on the patient’s comfort level and diaphragm stimulation needs.

According to Synapse, recent studies have shown that when NeuRx is implemented into a spinal cord injury patient’s treatment plan at an early stage, it may not only reduce the total time spent on a ventilator but also cut down on patients’ hospital stays by an average of 19 days and save hospitals about $140,000 per patient.

The device is approved for use in stable patients aged 18 and up, who can use the stimulation system for breathing support in sessions of at least four and up to 24 hours per day.

Prior to receiving the full FDA approval for the device, Synapse had also racked up regulatory green lights in Europe, Canada and beyond.

And while the latest FDA nod only covers the use of NeuRx for those with spinal cord injuries, it’s also been used to provide breathing support for people with amyotrophic lateral sclerosis. That indication scored another humanitarian use exemption from the FDA in 2011.

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