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WaveWriter Alpha spinal cord stimulator system IPGs and mySCS app on mobile.

WaveWriter Alpha™ SCS System

FAST™ and Contour™ Advanced Therapies

Advancing SCS Therapies

Boston Scientific advanced the science of spinal cord stimulation by introducing Combination Therapy – the ability to engage multiple mechanisms of action simultaneously. We have taken that advancement a step further by targeting a distinct SCS mechanism of action with FAST Therapy.1

Profound Paresthesia-Free* Pain Relief in Minutes with our Proprietary FAST Therapy

Now patients can experience significant results before they leave your clinic, giving you and your patients confidence in their SCS therapy.

  • Targets surround inhibition: a distinct SCS MOA1
  • Maximizes your patients' SCS experience
  • Available in both the trial and permanent implant

Use our proprietary FAST Therapy today

Diagram of spine with location of FAST Therapy highlighted.

Broad Coverage. Greater Efficiency.

Our Contour Therapy delivers broad paresthesia-free coverage across multiple neural targets – now with enhanced energy efficiency.

  • Optimized to use less energy than conventional paresthesia-free therapies2
  • Personalized to each patient's unique anatomy
  • Designed to mitigate loss of therapy due to lead migration
Diagram of spine with location of Contour Therapy highlighted.

Combination Therapies. Amplify Success.

In addition to offering the latest advanced therapies, Boston Scientific is the only company that can deliver therapies simultaneously for lasting relief tailored to each patient's needs.

Diagram of spine with location of Illumina 3D targeting highlighted.

Illumina 3D

Precise targeting

Diagram of spine with location of dorsal horn modulation highlighted.

Dorsal column stimulation

Diagram of spine with location of Contour Therapy highlighted.

Optimized Contour Therapy

Broad, energy-efficient, paresthesia-free coverage

Diagram of spine with location of dorsal column stimulation highlighted.

Dorsal horn modulation

Diagram of spine with location of FAST Therapy highlighted.

FAST Therapy

Immediate and profound paresthesia-free pain relief

Diagram of spine with location of surround inhibition highlighted.

Surround inhibition

Supported by Ongoing Comprehensive Clinical Evidence

The WaveWriter Alpha SCS System is backed by published data demonstrating immediate and profound pain relief with FAST Therapy, with long-term outcomes supported by 2-year Level I COMBO RCT data and 2-year real-world WaveWriter outcomes data. 

Level 1 COMBO RCT6

Level 1 COMBO RCT charts showing results at 2 years: 85% patients at or above 50% pain relief, 25 ODI improvement, 85% patient satisfaction.

A device capable of delivering Combination Therapy achieves a high level of clinical and functional success out to 2 years.

FAST Prospective Anitescu Study4

Overall Pain data chart showing reduction of low back pain scores, from 7.7 to 1.6 at 3-month visit.
Overall Pain data charts showing reduction of pain from programming session to follow-up.

Bayerl FAST-Preferred Long-Term Outcomes5

Overall Pain data chart showing reduction of low back pain scores, from 7.8 to 2.8 at 1-year visit.
Overall Pain data chart showing reduction of low back pain scores, from 7.6 to 2.1 at 2-year visit.

FAST Therapy Metzger Study3

Overall Pain data chart showing reduction of pain scores, from 6.5 pre-FAST to 1.8 post-FAST Therapy.
Overall Pain data chart showing reduction of pain scores, from 8.4 baseline to 1.7 at 6-month visit.

In a published observational case-series, FAST Therapy demonstrated profound paresthesia-free pain relief within minutes and ongoing efficacy at both the 3- and 6-month follow-up post implant.

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Comprehensive portfolio of therapies for chronic pain

Vertiflex Procedure indirect decompression system spacers.

LSS Treatment
See how the Vertiflex™ Procedure† is setting the standard of care for lumbar spinal stenosis (LSS).

G4 generator for radiofrequency ablation.

Radiofrequency Ablation
Learn about our radiofrequency ablation technology that interrupts pain signals.

Four WaveWriter Alpha SCS System models with mySCS app on Mobile phone.

SCS Portfolio
Explore all of our spinal cord stimulator systems and leads.

MRI conditional symbol.

The WaveWriter Alpha™ SCS System provides safe access to full-body MRI scans when used with specific components and the patient is 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 System. 

*Subperception stimulation has been demonstrated to be safe and effective in patients who have been treated successfully with conventional, paresthesia-inducing stimulation for at least six months. Full stimulation parameter ranges and options for both paresthesia based and subperception therapy are available for clinician’s use throughout the patient’s experience and treatment with SCS. 

1. Gilbert JE, Titus N, Zhang T, Esteller R, Grill WM. Surround Inhibition Mediates Pain Relief by Low Amplitude Spinal Cord Stimulation: Modeling and Measurement. eNeuro. 2022 Oct 5;9(5):ENEURO.0058-22.2022.

2. Paz-Solís J, Thomson S, Jain R, Chen L, Huertas I, Doan Q. Exploration of High- and Low-Frequency Options for Subperception Spinal Cord Stimulation Using Neural Dosing Parameter Relationships: The HALO Study. Neuromodulation. 2022 Jan;25(1):94-102.

3. Metzger CS, Hammond MB, Paz-Solis JF, et al. A novel fast-acting sub-perception spinal cord stimulation therapy enables rapid onset of analgesia in patients with chronic pain. Expert Rev Med Devices. 2021 Mar;18(3):299-306.

4. Anitescu M., et al. Clinical Outcomes of a Novel, Fast-Acting Sub-Perception SCS Therapy Engaging Surround Inhibition (FAST Prospective Study) [Abstract]. Twenty-Sixth Annual Meeting of the North American Neuromodulation Society, January 12-15, 2023.

5. Bayerl S., et al. Clinical Outcomes Using A New Fast-Acting Sub-Perception Therapy For Chronic Pain:  A Multicenter European Observational Real-World Study [Abstract]. Twenty-Sixth Annual Meeting of the North American Neuromodulation Society, January 12-15, 2023.

6. Wallace MS, North JM, Phillips GM, et al. Combination therapy with simultaneous delivery of spinal cord stimulation modalities: COMBO randomized controlled trial. Pain Manag. 2023 Mar 3.

† Superion™ Indirect Decompression System

‡ ImageReady(TM) MRI Full Body Guidelines for WaveWriter Alpha(TM) and WaveWriter Alpha(TM) Prime Spinal Cord Stimulator Systems. 92395577-02
MRI Guidelines for Medtronic Neurostimulation Systems for Chronic Pain. M939858A010 Rev C
1.5 Tesla and 3 Tesla Magnetic Resonance Imaging (MRI) Guidelines for the SENZA®, SENZA II® & SENZA Omnia™ Systems. 11096 Rev J
MRI Procedure Information For Abbott Medical MR Conditional Neurostimulation Systems. ARTEN600090483 A

INDICATIONS FOR USE The Boston Scientific Spinal Cord Stimulator Systems 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 the following: failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS) Types I and II, intractable low back pain and leg pain. Associated conditions and etiologies may be: radicular pain syndrome, radiculopathies resulting in pain secondary to failed back syndrome or herniated disc, epidural fibrosis, degenerative disc disease (herniated disc pain refractory to conservative and surgical interventions), arachnoiditis, multiple back surgeries. Contraindications, warnings, precautions, side effects. The SCS Systems are contraindicated for patients who: are unable to operate the SCS System, have failed trial stimulation by failing to receive effective pain relief, are poor surgical candidates, or are pregnant. Refer to the Instructions for Use provided with the SCS System or for potential adverse effects, warnings, and precautions prior to using this product.

CONTRAINDICATIONS Patients contraindicated for permanent Spinal Cord Stimulation (SCS) therapy are those who:
- are unable to operate the System
- have failed trial stimulation by failing to receive effective pain relief
- are poor surgical candidates
- are pregnant

SAFETY INFORMATION WARNING: Unauthorized modification to the medical devices is prohibited. System integrity could be compromised and harm or injury to the patient could occur if the medical devices are subjected to unauthorized modification.

Magnetic Resonance Imaging (MRI) - The WaveWriter Alpha and WaveWriter Alpha Prime SCS Systems are “MR Conditional”. An MRI examination can be conducted safely only when using a 1.5 Tesla horizontal closed bore whole body MRI system for the MRI scan and following all instructions in the supplemental manual “ImageReady™ MRI Full Body Guidelines for WaveWriter Alpha™ and WaveWriter Alpha™ Prime Spinal Cord Stimulator Systems”. The 1.5T MRI system can be configured to use the Full Body, Head, and Extremity transmit/receive RF quadrature coils, and receive only coils of any type. It is important to read the information in the supplemental manual in its entirety before conducting or recommending an MRI examination on a patient with a WaveWriter Alpha or WaveWriter Alpha Prime SCS System. The “ImageReady™ MRI Full Body Guidelines for WaveWriter Alpha™ and WaveWriter Alpha™ Prime Spinal Cord Stimulator Systems” manual appears on the Boston Scientific websites ( and MRI examinations performed on patients with the WaveWriter Alpha or WaveWriter Alpha Prime SCS System using opensided MRI systems, or other types of MRI systems operating at other static magnetic field strengths (higher or lower), have not been assessed and, as such, should not be performed. - External Devices: External components (for example, the ETS, Remote Control, and Battery Charger) are MR Unsafe. They must not be taken into any MR environment such as the MRI scanner room.

Heat Due to Charging (for rechargeable IPGs).
Patients should not charge while sleeping. This may result in a burn. While charging, the Charger may become warm. It should be handled with care. Failure to use the Charger with either the Charging Belt or an adhesive patch, may result in a burn. If patients experience pain or discomfort, they should cease charging and contact Boston Scientific.
Pediatric Use. The safety and effectiveness of stimulation has not been established for pediatric use.
Diathermy. Shortwave, microwave and/ or therapeutic ultrasound diathermy should not be used on SCS patients with a stimulator. The energy generated by diathermy can be transferred through the Stimulator system, causing tissue damage at the lead site and resulting in severe injury or death. The IPG, whether it is turned on or off, may be damaged.
Implanted Stimulation Devices. Stimulators may interfere with the operation of implanted sensing stimulators such as pacemakers or cardioverter defibrillators. The effects of implanted stimulation devices on neurostimulators is unknown.
Stimulator Damage. Burns may result if the pulse generator case is ruptured or pierced and patient tissue is exposed to battery chemicals. Do not implant the device if the case is damaged.
Postural Changes. Patients should be advised that changes in posture or abrupt movements may cause decreases, or uncomfortable or painful increases in the perceived stimulation level. Patients should be advised to turn down the amplitude or turn off the IPG before making posture changes. If using therapy that does not produce a sensation (subperception), postural changes are less likely to affect the patient.
Important: If unpleasant sensations occur, the IPG should be turned off immediately.
Electromagnetic Interference. Strong electromagnetic fields can potentially turn stimulation off, cause temporary unpredictable changes in stimulation, or interfere with Remote Control communication. If an electromagnetic field is strong enough to turn stimulation off, this will be temporary and stimulation will automatically return or stimulation can be turned on using the remote control once the electromagnetic field is removed. Patients should be advised to avoid or exercise care around the following:
- Theft detectors, tag deactivators and RFID devices, such as those used at department stores, libraries, and other public establishments: Patients should proceed with caution, ensuring that they move through the center of the detector as quickly as possible. Interference from these devices should not cause permanent damage to the implanted device.
- Security screeners, such as those used in Airport Security or at entrances to government buildings, including hand
-held scanners: Patients should request assistance to bypass the security screener and advise the security staff that they have an implanted medical device. If patients must pass through the security screener, they should move through the security screener quickly and stay as far as allowed from the screener.
- Power lines or power generators.
- Electric steel furnaces and arc welders.
- Large magnetized stereo speakers.
- Strong magnets.
- Automobiles or other motorized vehicles using a LoJack system or other anti-theft systems that can broadcast a radio frequency (RF) signal. The high energy fields produced by these systems may interfere with the operation of the Remote Control and its ability to control stimulation.
- Other sources of electromagnetic disturbance, such as Wi-Fi routers, Cordless Phones, Bluetooth® Wireless streaming devices, Baby Monitors, Microwave Ovens.

Note: When in close proximity, equipment that generate strong electromagnetic fields might cause unintended stimulation or interfere with wireless communication even if they comply with CISPR requirements.

Physician training is required. 

Medical Devices/Therapies. The following medical therapies or procedures may turn stimulation off or may cause permanent damage to the Stimulator, particularly if used in close proximity to the device:
- lithotripsy
- electrocautery (See “Instructions for the Physician” on page 10)
- external defibrillation
- radiation therapy (Any damage to the device by radiation may not be immediately detectable.)
- ultrasonic scanning
- high
- output ultrasound

X-ray and CT scans may damage the Stimulator if stimulation is on. X-ray and CT Scans are unlikely to damage the Stimulator if stimulation is turned off.

If any of the above is required by medical necessity, refer to “Instructions for the Physician” on page 10. Ultimately, however, the device may require explantation as a result of damage to the device.

Subperception Therapy. Subperception stimulation has been demonstrated to be safe and effective in patients who have been treated successfully with conventional, paresthesia-inducing stimulation for at least six months. Full stimulation parameter ranges and options for both paresthesia -based and subperception therapy are available for clinician’s use throughout the patient’s experience and treatment with SCS.

Automobiles and Other Equipment. Patients using therapy that generates paresthesia should not operate motorized vehicles such as automobiles or potentially dangerous machinery and equipment with the stimulation on. Stimulation must be turned off first in such cases. For these patients, any sudden stimulation changes may distract patients from proper operation of the vehicle, machinery, or equipment. For therapy that does not generate paresthesia (e.e., subperception therapy) it is less likely that sudden stimulation changes resulting in distraction could occur while having stimulation on when operating moving vehicles, machinery, and equipment.

Post Operative. During the two weeks following surgery, it is important that patients use extreme care so that appropriate healing will secure the implanted components and close the surgical incisions:
- Patients should not lift objects of more than 2.5 kg (5 lb).
- Patients should not engage in rigorous physical activity such as twisting, bending, or climbing.
- If new leads were implanted, patients should not raise their arms above their head.

Temporarily, there may be some pain in the area of the implant as the incisions heal. Patients should be instructed that if discomfort continues beyond two weeks, they should contact their healthcare provider. If patients notice excessive redness around the wound areas during this time, they should contact their healthcare provider to check for infection and administer proper treatment. In rare cases, adverse tissue reaction to implanted materials can occur during this period.

Patients should consult their healthcare provider before making lifestyle changes due to decreases in pain.

Stimulator Orientation. Patients should never attempt to change the orientation of the Stimulator or turn over the Stimulator. Patients should avoid touching the incisions or Stimulator site. If the Stimulator flips over in the Patient’s body, it may be unable to communicate with the Remote Control or Clinician Programmer. If the rechargeable Stimulator flips over in the Patient’s body, it cannot be charged. If the Patient knows that the device has turned, or if stimulation cannot be turned on after charging, the Patient should contact his or her physician to arrange an evaluation of the system. In some cases, the skin over the Stimulator may become very thin over time. If this occurs, Patients should contact their healthcare provider.

Lead Location. In some instances a lead can move from its original location, and stimulation at the intended pain site can be lost. If this occurs, Patients should consult their healthcare provider who may able to restore stimulation by reprogramming the Stimulator in the clinic or repositioning the lead during another operation.

Device Failure. Stimulators can fail at any time due to random component failure, loss of battery functionality, or lead breakage. If the device stops working even after complete charging (up to four hours), Patients should turn off the Stimulator and contact their healthcare provider so that the system can be evaluated.

Operating Temperature. The operating temperature of the ETS and Remote Control is 5 to 40 °C (41 to 104 °F). For proper operation, do not use the Charger if the ambient temperature is above 35 °C (95 °F). Non-rechargeable IPGs will enter storage mode if its temperature falls below 8 °C. When the IPG is in storage mode, it will not connect to a Remote Control or Clinician Programmer. To exit storage mode, increase the IPG temperature above 8 °C.

Storage, Handling and Transport. Do not expose the Remote Control or Charging System components to excessively hot or cold conditions. Do not leave the devices in your car or outdoors for extended periods of time. The sensitive electronics can be damaged by temperature extremes, particularly high heat. If the Remote Control or the Charging System is to be stored for a period of time without batteries, the storage temperature should not exceed -20 to 60 °C (-4 to 140 °F). Handle the system external components and accessories with care. Do not drop them or submerge them in water. Although reliability testing has been performed to ensure quality manufacturing and performance, dropping the devices on hard surfaces or in water, or other rough handling, can permanently damage these components. (See “Limited Warranty - IPG”.) Upon completion of the Patient Trial, remove the batteries from the ETS.

Component Disposal. Do not dispose of the Remote Control or Charger in fire. The battery in these devices can explode in fire. Dispose of used batteries in accordance with local regulations. The IPG should be explanted in the case of cremation, and returned to Boston Scientific. External devices to be disposed of per local regulatory requirements. Patients should contact their healthcare provider.

Remote Control, Charging System, and External Trial Stimulator Cleaning. The charging system components can be cleaned using alcohol or a mild detergent applied with a cloth or tissue. The Remote Control and ETS can be cleaned using a mild detergent applied with a lightly dampened cloth or tissue. Residue from soapy detergents should be removed with a cloth lightly dampened with water. Do not use abrasive cleansers for cleaning. Cleaning wipes for the External Trial Stimulator can also be ordered through Boston Scientific customer service. As an operator of the external devices, perform only the following service and maintenance tasks on the external devices:
- Changing the battery
- Charging the battery
- Cleaning

Ensure that the devices are not in use while performing service and maintenance tasks. Do not clean any of the accessories while they are directly or indirectly connected to a power outlet.

Cell Phones. While we do not anticipate any interference with cell phones, the full effects of interaction with cell phones are unknown at this time. Portable RF communications equipment (for example mobile phones) should be kept a minimum distance of 6 inches (15 centimeters) from the area of the implanted device. If there is a concern or a problem is encountered, the patients should contact their healthcare provider.

ADVERSE EVENTS Potential risks are involved with any surgery. The possible risks of implanting a pulse generator as part of a system to deliver spinal cord stimulation include:
- Lead migration, resulting in undesirable changes in stimulation and subsequent reduction in pain relief.
- System failure, which can occur at any time due to random failure(s) of the components or the battery. These events, which may include device failure, lead breakage, hardware malfunctions, loose connections, electrical shorts or open circuits and lead insulation breaches, can result in ineffective pain control.
- Tissue reaction to implanted materials can occur. In some cases, the formation of reactive tissue around the lead in the epidural space can result in delayed onset of spinal cord compression and neurological/sensory deficit, including paralysis. Time to onset is variable, possibly ranging from weeks to years after implant.
- Skin erosion at the IPG site can occur over time.
- Possible surgical procedural risks are: temporary pain at the implant site, infection, cerebrospinal fluid (CSF) leakage and, although rare, epidural hemorrhage, seroma, hematoma and paralysis.
- External sources of electromagnetic interference may cause the device to malfunction and affect stimulation.
- Exposure to magnetic resonance imaging (MRI) can result in discomfort or injury due to heat near the Stimulator or the leads, tugging or vibration of the implanted system, induced stimulation, damage to the device requiring its replacement, and may distort the image needed for diagnosis.
- Undesirable stimulation may occur over time due to cellular changes in tissue around the electrodes, changes in electrode position, loose electrical connections and/or lead failure.
- The patient may experience painful electrical stimulation of the chest wall as a result of stimulation of certain nerve roots several weeks after surgery.
- Over time, the Stimulator may move from its original position.
- Weakness, clumsiness, numbness or pain below the level of implantation.
- Persistent pain at the IPG or lead site. In any event, instruct the patient to contact their healthcare provider to inform him/her.

Caution: U.S. Federal law restricts this device to sale by or on the order of a physician.