FDA approves Spinal Cord Therapy

Nevro Corp, https://www.nevro.com, a global medical device company providing an innovative solution to treat chronic pain, has received FDA https://www.fda.gov approval for their Senza® System to treat chronic pain associated with Painful Diabetic Neuropathy (PDN).

The SCS system is an implanted rechargeable spinal cord stimulation system intended to treat long term chronic pain in the trunk or limbs that are difficult to manage. The main components of the SCS system includes an implanted signal generator that is connected to one or two implanted leads and a remote control that can turn the stimulator ON or OFF to allow adjustments to the therapy settings.

The implanted signal generator receives radio signals from the remote control which tells the signal generator when to deliver appropriate stimulation to the spinal cord. The external remote control is battery operated and can be controlled by the patient or a healthcare provider.

According to D. Keith Grossman, Chairman, CEO, and President of Nevro, “FDA’s approval marks an achievement demonstrating the strength of our clinical data and provides a proven new breakthrough SCS treatment option for PDN patients who are struggling with debilitating pain and are unable to find relief with currently available pharmacologic options.

The company anticipates a mid-single digit million revenue contribution from PDN in 2021 which is expected to be generated in the fourth quarter with broader penetration and a larger revenue contribution expected in 2022 and beyond.

The revenue ramp is expected to build gradually during the initial months following the launch as awareness increases among referring physicians, as patient move through the referral to trial to permanent implant pathway, and access to insurance payers expands.

 

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