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Here’s the proof it works

Boston Scientific chronic pain solutions are backed by solid clinical evidence.

Spinal Cord Stimulation (SCS)

Getting You Back to Everyday Activities

In a major clinical study, patients using Boston Scientific's SCS therapies reported a greater improvement in their ability to do everyday activities* than patients reported in other studies using non-Boston Scientific SCS systems.1, 2, 3

Significant Long-Term Relief

In another major clinical study, patients with severe low-back pain (8 or above on a 0-10 scale) reported a nearly 6-point drop in pain score at two years.4

Worldwide Success

Tens of thousands of people across the globe look to Boston Scientific SCS therapy for long-term, drug-free, FDA-approved pain relief.

Successful Trials

More than 90% of Boston Scientific SCS trial participants reported a successful experience and opted to get the permanent implant.5

Patient Satisfaction

9 out of 10 Boston Scientific SCS patients said they were satisfied with their therapy and 95% would recommend it to others.5

Vertiflex™ Procedure†

The minimally invasive Vertiflex Procedure is FDA approved and backed by a long-term clinical study.

Over 20,000 patients have received pain relief from the Vertiflex Procedure since FDA approval.

In the clinical study, most patients on opioids stopped using them after the Vertiflex Procedure.6**

Nine out of ten patients in the clinical study were satisfied with their pain relief and increase in physical activity.7‡

Radiofrequency Ablation (RFA)

Studies show that more than 70% of patients treated with RFA experience relief—lasting anywhere from six to 12 months, and in some cases, years.8-10

Let’s find your relief

Wondering if these solutions may be right for you? Take this quick quiz and find out.

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Question 1 / 8

Have you been suffering from pain
for more than 6 months?

*As measured by the Oswestry Disability Index at 3 months post implant.

†Superion™ Indirect Decompression System.

**Decrease in the proportion of patients using opioids compared to baseline at five years.

‡Study completers.

References: 1. Wallace M. et al. Outcomes of a Prospective Randomized Controlled Trial Utilizing a Spinal Cord System Capable of Multiple Neurostimulation Modalities (COMBO). NANS Annual Meeting. January 2020 (N=41) 2. Kapural, Cong Yu, et al. Novel 10-kHz High-frequency Therapy (HF10 Therapy) Is Superior to Traditional Low-frequency Spinal Cord Stimulation for the Treatment of Chronic Back and Leg Pain: The SENZA-RCT Randomized Controlled Trial. Anesthesiology 2015; 123:851 -860 3. Deer, Timothy, et al. Success Using Neuromodulation With BURST (SUNBURST) Study: Results From a Prospective, Randomized Controlled Trial Using a Novel Burst Waveform. Neuromodulation: Technology at the Neural Interface. 21. 10.1111/ner.12698  4. Veizi E, Hayek SM, North J, et al. Spinal cord stimulation (SCS) with anatomically guided (3D) neural targeting shows superior chronic axial low back pain relief compared to traditional SCS—LUMINA Study. Pain Med. 2017;18(8):1534-1548. 5. Thomson SJ, Kruglov D, Duarte RV. A spinal cord stimulation service review from a single centre using a single manufacturer over a 7.5 year follow-up period. Neuromodulation. 2017;20(6):589-599. N=321 6. Nunley PD, Deer TR, Benyamin RM, Staats PS, Block JE. Interspinous process decompression is associated with a reduction in opioid analgesia in patients with lumbar spinal stenosis. J Pain Res. 2018;11:2943-2948. 7. Nunley PD, Patel VV, Orndorff DG, Lavelle WF, Block JE, Geisler FH. Five-year durability of stand-alone interspinous process decompression for lumbar spinal stenosis. Clin Interv Aging. 2017;12:1409-1417. N=88 8. MacVicar J, Borowczyk JM, MacVicar AM, Loughnan BM, Bogduk N. Cervical medial branch radiofrequency neurotomy in New Zealand. Pain Med. 2012;13(5):647-654. 9. Dreyfuss P, Halbrook B, Pauza K, Joshi A, McLarty J, Bogduk N. Efficacy and validity of radiofrequency neurotomy for chronic lumbar zygapophysial joint pain. Spine. 2000;25(10):1270-1277. 10. Govind J, King W, Bailey B, Bogduk N. Radiofrequency neurotomy for the treatment of third occipital headache. J Neurol Neurosurg Psychiatry. 2003;74(1):88-93.

Results from clinical studies are not predictive of results in other studies. Results in other studies may vary.

 

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. The Spinal Cord Stimulator systems are not for patients who are unable to operate the system, have failed trial stimulation by failing to receive effective pain relief, are poor surgical risks, or are pregnant.

Boston Scientific’s ImageReady™ MRI Technology makes safe MRI head scans possible. Patients implanted with the Precision Spectra™ or Spectra WaveWriter™ Spinal Cord Stimulator Systems with ImageReady™ MRI Technology are ""MR Conditional"" only when exposed to the MRI environment under the specific conditions defined in the applicable ImageReady™ MRI Head Only Guidelines for Precision Spectra™ or Spectra WaveWriter™ Spinal Cord Stimulator Systems.

Boston Scientific’s ImageReady™ MRI Full Body Technology makes safe MRI scans possible. The Precision Montage™ MRI, WaveWriter Alpha™ and WaveWriter Alpha™ Prime SCS Systems with ImageReady™ MRI Full Body Technology are “MR Conditional” only when exposed to the MRI environment under the specific conditions defined in the applicable ImageReady™ MRI Full Body Guidelines for Precision Montage™ MRI or WaveWriter Alpha™ and WaveWriter Alpha™ Prime Spinal Cord Stimulator Systems.

Warnings. Patients implanted with Boston Scientific Spinal Cord Stimulator Systems without ImageReady™ MRI Technology should not be exposed to Magnetic Resonance Imaging (MRI). Exposure to MRI may result in dislodgement of the stimulator or leads, heating of the stimulator, severe damage to the stimulator electronics and an uncomfortable or jolting sensation. As a Spinal Cord Stimulation patient, you should not have diathermy as either a treatment for a medical condition or as part of a surgical procedure. Strong electromagnetic fields, such as power generators or theft detection systems, can potentially turn the stimulator off, or cause uncomfortable jolting stimulation. The system should not be charged while sleeping. The Spinal Cord Stimulator system may interfere with the operation of implanted sensing stimulators such as pacemakers or implanted cardiac defibrillators. Advise your physician that you have a Spinal Cord Stimulator before going through with other implantable device therapies so that medical decisions can be made and appropriate safety measures taken. 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 therapy that does not generate paresthesia (i.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. Your doctor may be able to provide additional information on the Boston Scientific Spinal Cord Stimulator systems. For complete indications for use, contraindications, warnings, precautions, and side effects, call 866.360.4747 or visit Pain.com.

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

Indications for Use. The Superion™ Indirect Decompression System (IDS) is indicated to treat skeletally mature patients suffering from pain, numbness, and/or cramping in the legs (neurogenic intermittent claudication) secondary to a diagnosis of moderate degenerative lumbar spinal stenosis, with or without Grade 1 spondylolisthesis, having radiographic evidence of thickened ligamentum flavum, narrowed lateral recess, and/or central canal or foraminal narrowing. The Superion™ Interspinous Spacer is indicated for those patients with impaired physical function who experience relief in flexion from symptoms of leg/buttock/groin pain, with or without back pain, who have undergone at least 6 months of non-operative treatment. The Superion Interspinous Spacer may be implanted at one or two adjacent lumbar levels in patients in whom treatment is indicated at no more than two levels, from L1 to L5.

Contraindications, warnings, precautions, side effects. The Superion Indirect Decompression System (IDS) is contraindicated for patients who: have spinal anatomy that prevent implantation of the device or cause the device to be unstable in situ (i.e., degenerative spondylolisthesis greater than grade 1), Cauda equina syndrome, or prior decompression or fusion at the index level, scoliosis or spinous process fractures, osteoporosis, infection, allergy or reaction to any metal or implant or a high Body Mass Index. Avoid strenuous activity for 6 weeks after surgery, contact your physician if there is fluid leaking from your incision, if you have pain, swelling or numbness in your legs or buttocks or if you fall. Refer to the Instructions for Use provided on www.vertiflex.com for additional Indications for Use, contraindications information and potential adverse effects, warnings, and precautions prior to using this product.

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

Indications for Use. The Boston Scientific Radiofrequency Generators, associated Radiofrequency Lesion Probes and RF Cannula are indicated for use in procedures to create radiofrequency lesions for the treatment of pain or for lesioning nerve tissue for functional neurosurgical procedures. The Boston Scientific RF Injection Electrodes are used for percutaneous nerve blocks with local anesthetic solution for radiofrequency lesioning of peripheral nerve tissue only. The Boston Scientific LCED and Stereotactic TCD Electrodes are indicated for use in radiofrequency (RF) heat lesioning of nervous tissue including the Central Nervous System.

Warnings. For a patient with a cardiac pacemaker, contact the pacemaker company to determine whether the pacemaker needs to be converted to fixed rate pacing during the radiofrequency procedure. Refer to the Instructions for Use provided with Boston Scientific generators, electrodes and cannulas for potential adverse effects, additional warnings and precautions prior to using these products.

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