Boston Scientific has announced that its WaveWriter Alpha spinal cord stimulation (SCS) systems will have a limited market release in the USA. The SCS portfolio is intended for personalised pain relief.
According to a company press release, the unified portfolio of four MRI conditional, Bluetooth-enabled rechargeable and non-rechargeable implantable pulse generators (IPGs) provides personalisation, and for the first time in SCS, Fast Acting Sub-perception Therapy (FAST), designed to deliver profound paresthesia-free pain relief in minutes. The systems are supported by the Cognita Solutions suite of digital tools for patients and physicians.
According to Boston Scientific, SCS therapies provide pain relief by sending mild electric pulses to the spinal cord to interrupt pain signals traveling to the brain. Paresthesia-based therapy provides pain relief with a light tingling sensation while paresthesia-free therapy works without that sensation.
The company claims that traditional paresthesia-free therapy can take up to a few days or longer to provide pain relief, but its proprietary FAST therapy is designed to provide immediate paresthesia-free pain relief by targeting a new and distinct SCS mechanism of action revealed through a multi-year research collaboration with Duke University.
“We have found that the specific targeting and stimulation parameters of FAST uniquely engage the surround inhibition mechanism to produce rapid and robust pain relief,” commented Warren M Grill (Duke University, Durham, USA). “What sets FAST apart from other forms of SCS is that we understand the underlying mechanism, which helps define clinical practices to optimise patient outcomes,” he adds.
Boston Scientific report that the WaveWriter Alpha SCS Systems are supported by Cognita Solutions to address common challenges in pain management, including raising awareness about drug-free pain management options, helping patients find local physicians, and helping physicians sustain functional outcomes for patients over the long-term.
The WaveWriter Alpha SCS Systems were approved by the US Food and Drug Administration (FDA) in December 2020 and are indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with failed back surgery syndrome, complex regional pain syndrome types I and II, intractable low back pain and leg pain.