NeuRx Diaphragm Pacing System use approved by Health Canada

NeuRx Diaphragm Pacing System use approved by Health Canada

DECEMBER, VANCOUVER, BC - U.S.-based Synapse Biomedical has received approval from Health Canada for its NeuRx Diaphragm Pacing System (DPS), designed to assist people with spinal cord injuries (SCI) who lack control of their diaphragms and are ventilator-dependent.

With this Health Canada approval, SCI patients throughout Canada can access this technology that was only previously available to clinical trial participants or through the Medical Devices Special Access Program.

The approval is based on patient data supplied from clinical trials at hospitals in the US and Canada, including Vancouver General Hospital, and is a great example of the power of the Rick Hansen Institute network.

A Collaborative Effort

This approval is the outcome of years of clinical research that began in 2007 when the Rick Hansen Foundation funded the DPS procedure for a young Vancouver man, who had sustained a high-level SCI in a mountain biking accident, and looked forward to adaptive sailing – all but impossible while dependent on a heavy, battery-powered ventilator.

The surgery was performed in Cleveland, OH – Dr. John Yee (Thoracic surgeon, Vancouver Coastal Health) attended the surgery in order to learn the procedure. Dr. Yee and Dr. Jeremy Road (Respirologist, Vancouver Coastal Health) then launched a clinical trial, and performed numerous DPS procedures in Vancouver over the next few years. The Rick Hansen Institute and Rick Hansen Foundation assisted with funds to enable individuals from across Canada to access the procedure in Vancouver. The Ontario Neurotrauma Foundation (ONF) sponsored additional DPS procedures in London, ON.

In 2010, Drs. Yee and Road, in collaboration with Synapse Biomedical, submitted their clinical data to Health Canada, and requested the procedure be approved in Canada .

Fast forward to 2013 – Health Canada had not yet approved the DPS procedure, but Lise Belanger, a clinician in Vancouver, wanted to get a diaphragmatic pacemaker approved for a young patient on the acute spine unit at Vancouver General Hospital.

Through the RHSCIR site network she knew of another clinician (Dr. Colleen O’Connell) in New Brunswick who had gone through the arduous process of submitting an application for the Medical Devices Special Access Program for another patient (the process required by Health Canada for each individual patient prior to this approval) and was able to contact her for assistance.

Following Lise’s Special Access request, in which she re-emphasized the many benefits of DPS use (greatly reduced or eliminated ventilator dependence, the ability to taste and smell again, and minimized risk of pneumonia), she personally followed-up to ensure that Health Canada heard her patient's story emphasizing how this device could dramatically improve his quality of life. Health Canada approved the device not just for her individual patient, but for all patients across Canada with SCI who are ventilator-dependent and lack voluntary control of their diaphragms.

This approval will make it easier for eligible patients across Canada to access this device.

Prior to this approval a patient approved through the Medical Devices Special Access Program would have had to pay $35,000 for this device privately.

With this approval, hospitals can stock the device as surgical equipment which means that there is no cost to the patient.

About NeuRx DPS

NeuRx DPS is implanted through minimally invasive laparoscopic surgery and provides electrical stimulation of the muscles of the diaphragm. To be eligible, a patient’s diaphragm must show its ability to respond to stimulation.

During the procedure, a surgeon creates small holes in the abdomen and inserts a laparoscope so the diaphragm muscle can be seen. The surgeon then places small electrodes in the diaphragm.

Electrodes are then attached to a small external battery powered pulse generator, which stimulates the diaphragm, causing a contraction of muscle.

This allows air to fill the upper and lower parts of the lungs rather than forcing air in with a mechanical ventilator.

The stimulation is then used to condition the diaphragm, enabling the patient to breathe longer without the need of ventilator.

The device is controlled through a four-channel, battery-powered external pulse generator and eliminates the need for a source of electricity and concern for power outages.

Diaphragm dysfunction can result in abnormal or absent respiration in patient populations of high-level SCI and other injuries or diseases affecting the neuromuscular respiratory pathways.

In the US clinical trial, more than 50% of the eligible participants were able to completely eliminate their need for mechanical ventilation.

In November 2007, the NeuRx DPS received CE Mark for treating patients with diaphragm dysfunction and received the US Food and Drug Administration (FDA) approval for ventilator dependency from spinal cord injury in June 2008.

Says Dr. Jeremy Road, a Professor of Medicine at UBC and a Respirologist at Vancouver Hospital and UBC: "Although results may vary, some patients are provided the greatest freedom and are ventilator free for up to 24 hours a day."

This new approval enables SCI patients throughout Canada to access this technology that was only previously available to clinical trial participants or through the Medical Devices Special Access Program.

If you are interested in learning more about this device or how to access it for your patients, please contact Steven Annunziato, SVP Marketing & Sales, Synapse Biomedical Inc., sa1@synapsebiomedical.com, 1-440-787-0187, or visit the Synapse website at www.synapsebiomedical.com.