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TGA-APPROVED MEDICAL DEVICE OFFERS NEW WAY FOR DOCTORS TO TREAT PATIENTS’ CHRONIC BACK PAIN

Announcement posted by Nevro 16 Jun 2020

Australian launch

Medical professionals will soon have access to a new device to treat the 3.241 million Australians who suffer chronic pain and it’s already been given TGA-approval.

 

Nevro’s Omnia™ Spinal Cord Stimulation System delivers treatment for chronic back pain using frequency technology to stimulate the spinal cord.

 

It is the only product of its kind that can deliver all frequencies, between two and 10,000HZ. It also offers a waveform pioneered by Omnia, the HF10, which was found to reduce pain across two 24-month trials. In the SENZA-EU study, a multicenter back pain study conducted in Europe, the average opioid intake of the patients was decreased by nearly 70%, and the percentage of patients not taking opioids by two years had tripled (from 14% to 42%).2

 

Nevro’s Chief Commercial Officer Niamh Pellegrini said the product will be available to medical practitioners across Australia from July 1, following successful launches in the United States and Europe.

 

“Omnia was developed as a result of extensive feedback from physicians to provide a versatile solution to help more patients with chronic pain,” Ms Pellegrini said.

 

“With Omnia, patients will have access to the widest range of SCS frequencies, and physicians can have the peace of mind knowing they can provide their patients the broadest range of solutions for the best possible outcomes.”

 

The system is made up of a number of new components including a programmer which allows medical practitioners to vary the frequencies required by their patients and a remote which makes it easier for patients to use the device. It also features an implantable pulse generator which lasts more than a decade, is MRI safe and can be upgraded for future waveforms and frequencies.

 

Pain Specialist Australia Director Nick Christelis said he is looking forward to using Omnia’s updated programming suite.

 

“The TGA approval of the Omnia spinal cord stimulation system to treat chronic refractory pain will be a welcome new platform from Nevro,” Mr Christelis said.

 

“The new device reflects a more versatile solution to treat the changing, dynamic, and sometimes even progressive, nature of chronic pain.”

 

Nevro has created the NevroCloud system so patients are supported using the device and doctors can check in with how their patients are responding to the treatment.

 

Nevro has been granted TGA approval and the Senza® Omnia™ Spinal Cord Stimulation (SCS) system will appear on the 2020 Prostheses Listing.

 

A Media kit which includes approved image, fact sheet and additional media release is available.


1 Pain Australia Limited. Pain in Australia. Source: https://www.painaustralia.org.au/about-pain/painful-facts

2 Al-Kaisy A, et. al. Sustained effectiveness of 10 kHz high-frequency spinal cord stimulation for patients with chronic, low back pain: 24-month results of a prospective multicenter study. Pain Med. 2014;15:347-354.