Boston Scientific announces limited market release of SCS systems

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 personalisation, and for the first time in SCS, Fast Acting Sub-perception Therapy (FAST) designed to deliver paraesthesia-free pain relief in minutes. The systems are supported by the Cognita Solutions suite of digital tools for patients and physicians. 

SCS therapies provide relief to chronic pain sufferers by sending mild electric pulses to the spinal cord to interrupt pain signals traveling to the brain. Paraesthesia-based therapy provides pain relief with a light tingling sensation while paraesthesia-free therapy works without that sensation.

Traditional paraesthesia-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 paraesthesia-free pain relief by targeting a new and distinct SCS mechanism of action revealed through a multi-year research collaboration with Duke University. 

Warren M. Grill, professor of biomedical engineering, Duke University, said: "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. 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." 

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. 

Maulik Nanavaty, senior vice president and president, neuromodulation, Boston Scientific, said: "It is with great enthusiasm that we embark on the next era of personalisation with the WaveWriter Alpha SCS Systems. 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 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.