Boston Scientific Releases WaveWriter Alpha Spinal Cord Stimulators in U.S.

Boston Scientific has announced a limited market release of the WaveWriter Alpha portfolio of Spinal Cord Stimulator (SCS) systems. The unified portfolio of four MRI conditional, Bluetooth-enabled rechargeable and non-rechargeable implantable pulse generators (IPGs) provides uncompromised personalization, and for the first time in SCS, Fast Acting Sub-perception Therapy (FAST) designed to deliver profound paresthesia-free pain relief in minutes.¹ The systems are supported by the Cognita Solutions suite of digital tools for patients and physicians.
 
Chronic pain, defined as continuous and long-term pain lasting more than six months, impacts more than 50 million people in the U.S. with 19.6 million adults experiencing high-impact chronic pain that interferes with daily life or work activities.² 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.
 
Traditional paresthesia-free therapy can take up to a few days or longer to provide pain relief. Boston Scientific’s 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, distinguished professor of biomedical engineering, Duke University. “What sets FAST apart from other forms of SCS is that we understand the underlying mechanism, which helps define clinical practices to optimize patient outcomes.”
 
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.
 
“It is with great enthusiasm that we embark on the next era of personalization with the WaveWriter Alpha SCS Systems,” said Maulik Nanavaty, senior vice president and president, Neuromodulation, Boston Scientific. “Combined with our family of innovative and proven solutions for the treatment of chronic pain, including the Vertiflex Procedure and radiofrequency ablation, we are helping physicians provide treatments that span the continuum of care so patients can find access to the medical support they need to live better lives.”
 
The WaveWriter Alpha SCS Systems were approved by the U.S. Food and Drug Administration in December 2020 and is 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.
 
References
¹ The WaveWriter Alpha and WaveWriter Alpha Prime Spinal Cord Stimulator Systems provide safe access to full-body 1.5T MRI scans when used with specific components and exposed to the MRI environment under the defined conditions in the ImageReady MRI Full Body Guidelines for WaveWriter Alpha and WaveWriter Alpha Prime Spinal Cord Stimulator Systems
² U.S. Department of Health and Human Services (2019, May). Pain Management Best Practices Inter-Agency Task Force Report: Updates, Gaps, Inconsistencies, and Recommendations. Retrieved from U. S. Department of Health and Human Services website: https://www.hhs.gov/ash/advisory-committees/pain/reports/index.html