SPR Therapeutics gains FDA extended approval for pain management system

pharmafile | February 6, 2023 | News story | Research and Development  

Pain management medical device company SPR Therapeutics has obtained expanded approval from the FDA for its SPRINT Peripheral Nerve System (PNS) System.

 

The SPRINT PNS System is a 60-day treatment which reconditions the central nervous system (CNS) without the need for a permanent implant, any nerve destruction or risk of addiction to pain medication. It features one or two hair-like leads, implanted under the skin, which deliver continuous mild electrical pulses directly to the nerves to reduce pain signals.

 

It’s approved for the symptomatic relief of chronic, intractable pain, post-traumatic or -surgical pain and postoperative pain. Originally indicated for persons over 21, the expanded approval now indicates the device for patients aged 18 and over. It also now recommends the leads can be placed in the back of the head and neck to address pain in that region.

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However, it must not be used in the region innervated by the cranial and facial nerves.

 

SPR Therapeutics director of medical affairs Marc Huntoon said: “Our objective is to stay at the forefront of PNS innovation to reduce or eliminate pain, while minimising opioid treatments and the need for more destructive or invasive interventions. These labelling changes open the door to effectively reach younger patients that can benefit from our breakthrough treatment. We are a company driven by clinical research and devoted to improving the lives of people living with pain while anticipating the needs of our physician partners.”

 

James Spargo


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