Boston Scientific just won FDA approval for the first spinal cord neurostimulator system to provide both paresthesia-based and sub-perception therapy at the same time. The WaveWriter system delivers electrical stimulation that the patient can feel (paresthesia) or a type that is not directly felt, but experienced through reduced pain. The patient can choose either or combine the two to achieve the greatest pain reduction.
Stimulation varies in the electrical current’s frequency, pulse width, and amplitude, some of which are felt while others are not. It seems that there are a number of mechanisms that work together that can be targeted to help alleviate pain, some of which depend on direct sensation while others are more subconscious.
Because the type of pain that is felt often changes over time, it’s best to have multiple options available that can be used to follow along with the pain so as to squash it as necessary.
Here’s some basic info about a couple studies that led to the approval of the WaveWriter, according to Boston Scientific:
The PROCO study was a multi-center, prospective, double-blind, randomized study in which patients acted as their own control. This study established in de novo patients that similar pain relief and improvement in quality of life measures are achieved independent of the type of frequency (from 1 kHz up to 10 kHz) used in sub-perception SCS therapy when the proper target and dose are identified. The WHISPER study is a multi-center, prospective, cross-over, randomized, and controlled study evaluating the long-term safety and effectiveness of sub-perception SCS pain relief therapy.
Via: Boston Scientific…