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The Vertiflex™ Procedure†

Treatment and pain relief for Lumbar Spinal Stenosis (LSS)

When simple activities such as walking or standing become a burden, you may find relief from leg and back pain with the Vertiflex Procedure.

What is lumbar spinal stenosis (LSS)?

Leg and back pain may be the result of a condition called lumbar spinal stenosis. LSS leads to the narrowing of the space in the lower (or lumbar) spine where nerves pass through. The narrowing of the space causes constriction on the nerves, which may result in pain and discomfort down the back and into the legs.

Pain is usually worsened when standing or walking, and leaning forward or sitting down provides relief. For most people, LSS develops gradually over time and is most common in adults over the age of 60.

What causes LSS?

LSS is usually caused by normal wear and tear to the spine over time which leads to the narrowing of the spinal canal. This includes:

  • Osteoarthritis
  • Degenerative Disk Disease (DDD)
  • Thickened ligaments
  • Certain bone diseases

What are the symptoms of LSS?

  • Pain while walking or standing
  • Weakness in legs
  • Loss of balance
  • Decreased physical endurance
  • Numbness or tingling in the legs, buttocks, or back
  • Aching, dull back pain spreading to legs
  • Tendency to sit or lean over to relieve pain

What happens if LSS is left untreated?

If left untreated, lumbar spinal stenosis can lead to significant and permanent nerve damage. Symptoms may affect your balance, functionality and ability to perform day-to-day activities.

Learn about LSS and the Vertiflex Procedure

Watch how the Vertiflex Procedure can relieve leg and back pain associated with LSS.

How does the Vertiflex Procedure work?

The Vertiflex Procedure is a safe, minimally invasive treatment that has been clinically proven to provide effective long-term relief from the pain associated with LSS.

  • FDA approved
  • Same-day procedure
  • Quick recovery time
  • Covered by Medicare and several private insurance companies, based on medical necessity (Each insurance company and patient’s plan may vary. Please work with your physician to verify benefits and coverage.)

Placement

A small spacer is placed inside the spine without removal of any nearby bone or tissue.

Activation

Once inserted, the spacer’s arms open around the spinous processes (the bumps you can feel in your spine) to help make proper space for the affected nerves.

Relief

The spacer preserves the space in the spine, which keeps pressure off the nerves that cause leg and back pain.

How does the Vertiflex Procedure fit my pain?

The Vertiflex Procedure is intended to provide the same relief you experience when leaning forward or sitting down. It fits your pain by reducing or eliminating the pressure on the nerves caused by LSS. The spacer is also available in several different sizes to fit your anatomy.

Is the Vertiflex Procedure safe?

The Vertiflex Procedure was developed with patient safety and comfort in mind.

Its minimally invasive approach is preferred among many doctors across the United States.

General anesthesia is not required and there is minimal recovery time, getting you home the same day.

The spacer is designed to support your existing anatomy and does not require removal of bone or tissue, making it a safe option for LSS treatment.

Click here for important safety and risk information about the procedure

How effective is it?

The Vertiflex Procedure was the subject of an extremely thorough FDA clinical trial for LSS. Results from the trial proved the effectiveness of the procedure, with significant improvement in pain relief.

The procedure can be completed in an outpatient setting and most patients can return home within the same day.

Proven results

Nine out of ten patients in the clinical study were satisfied with their pain relief and increase in physical activity.1,‡

Learn more about the effectiveness of the Vertiflex Procedure

Real patient stories

Meet some of the people who found relief with the Vertiflex Procedure.

See Their Stories

Ready to find relief from LSS?

Locate pain management specialists near you that offer The Vertiflex Procedure.

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Life after the Vertiflex Procedure

The Vertiflex Procedure has helped thousands of people return to enjoying their day-to-day life again.

Postprocedure Care Guidelines

Wondering if the Vertiflex Procedure may be right for you?

Take this quick quiz and find out. ⟶

†Superion™ Indirect Decompression System.

‡Study completers.

References: 1. 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.

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, Diabetic Peripheral Neuropathy of the lower extremities, 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. The Boston Scientific Spectra WaveWriter™, WaveWriter Alpha™ and WaveWriter Alpha™ Prime SCS Systems are also indicated as an aid in the management of chronic intractable unilateral or bilateral low back and leg pain without prior back surgery.

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 candidates, or are pregnant.

MR Conditional symbol

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.

MR Conditional symbolBoston 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: The Boston Scientific RF devices may cause interference with active devices such as neurostimulators, cardiac pacemakers, and defibrillators. Interference may affect the action of these active devices or may damage them. For appropriate guidance, consult the instructions for use for these active devices. Caution: U.S. Federal law restricts this device to sale by or on the order of a physician.

§The physician locator tool identifies pain management specialists in your area who have met certain qualifying criteria and are experienced with one or more of Boston Scientific pain management therapies. All treatment options should be discussed thoroughly with a pain management specialist.