September 30, 2020
Boston Scientific today announced the European launch of the WaveWriter Alpha™ portfolio of Spinal Cord Stimulator (SCS) Systems. The portfolio, consisting of four MRI conditionali, Bluetooth-enabled implantable pulse generators (IPGs), offers expanded personalization based on patient needs, including rechargeable and non-rechargeable options, and access to waveforms that can cover multiple areas of pain.
Chronic pain, defined as continuous and long-term pain lasting more than 12 weeks, impacts approximately 100 million people across Europe.ii,iii SCS therapies provide pain relief by delivering pulses of mild electric current to the spinal cord to interrupt pain signals traveling to the brain. The WaveWriter Alpha SCS Systems received CE Mark and are indicated as an aid in the management of chronic intractable pain. It is also indicated for peripheral nerve stimulation of the trunk for pain management.
The systems feature combination therapy, the only SCS portfolio that has the ability to layer paraesthesia and paraesthesia-free options simultaneously and support up to 32 contacts that target specific nerves along the spinal cord to meet the personal pain relief coverage needs of the individual patient. The Bluetooth platform enables faster programming that can be done while maintaining a typical physical distance of 10 feet (3meters) between the programmer and the patient.
“Being able to offer my patients different therapy options is important because it provides them with pain relief that can maintain long-term results,” said Jan Vesper, M.D. Ph.D., Department of Functional Neurosurgery and Stereotaxy at the University Hospital of Düsseldorf, Germany. “The combination of different therapy features that promote simplicity like the WaveWriter Alpha SCS Systems enable enhanced personalization in the advanced treatment of chronic pain.”
The COMBO randomized control trial, which compared the effectiveness of SCS with multiple modalities to conventional SCS in patients with chronic pain, found 88% of patients were responders with multiple modalities, which is defined as patients achieving 50% or greater pain relief compared to baseline. Patients also realized a significant 26-point improvement in functional disabilityiv where many patients who were “severely” or “moderately disabled” were able to return to many of their daily activities.v Multiple Level 1 RCTs and real-world studies support the design of Boston Scientific’s SCS therapy.vi,vii,viii,ix,x
“Chronic pain can severely impact a patient’s ability to carry out daily activities,” said Jan Willem Kallewaard, M.D., Rijnstate Hospital, Arnhem, The Netherlands. “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.”
“The launch of the WaveWriter Alpha SCS Systems in Europe represent a significant step forward in the treatment of chronic pain,” said Maulik Nanavaty, senior vice president and president, Neuromodulation, Boston Scientific. “By unifying our portfolio of SCS devices and offering the latest therapy advances, we remain committed to advancing meaningful innovation, providing both physicians and patients access to the full benefits of our entire portfolio of devices.”
The WaveWriter Alpha SCS Systems are not available for use or sale in the United States.