Boston Scientific has launched their Wavewriter Alpha spinal cord stimulator (SMS) systems, to the European market, after receiving their CE mark. This product is intended to be used for the management of chronic intractable pain.
The Wavewriter Alpha works by delivering pulses of electric current to the spinal cord, interrupting pain signals as they travel to the brain.
This adds to Boston Scientific’s SMS portfolio, consisting of four MRI conditional, Bluetooth-enables implantable pulse generators (IPGs), which offers personalization for each patient. This includes rechargeable and non-rechargeable option.
These systems include combined therapy. Their SCS portfolio is able to layer paraesthesia and paraesthesia-free option concurrently, and provide up to 32 contacts targeting specific nerves along the spinal cord. Programming can be done via Bluetooth from a distance of ten feet (three meters).
The Combining Mechanisms for Better Outcomes (COMBO) trail looked at the effectiveness of SCS with multiple modalities when compared to conventional SCS patients with chronic pain. The mark for responding to the treatment was subject with a 50% greater reduction in pain from their baseline. This trial found that 88% of patients were responders with multiple modalities achieved this.
Additionally, the COMBO trial found an improvement in the functional disability of these patients, with patients who were categorised as “severely” or “moderately disable” being able to return to some daily activities.
Jan Willem Kallewaard, Rijnstate Hospital, the Netherlands, commented, “chronic pain can severely impact a patient’s ability to carry out daily activities… with the WaveWriter Alpha SCS Systems, not only are patients likely to achieve a successful outcome, but their quality of life is also being dramatically improved by regaining many functional abilities.”
While the Wavewriter Alpha SCS Systems has its CE Mark, it is not yet for sale in the USA.