The Vertiflex™ Procedure† Superion™ Indirect Decompression System
The Vertiflex Procedure is a clinically proven, minimally invasive solution that is designed to deliver long-term relief from the leg and back pain associated with Lumbar Spinal Stenosis.
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- Overview
- Clinical data
- Technical specifications
- Ordering information
- Training
- Resources
Setting the standard of care for lumbar spinal stenosis
The Vertiflex Procedure is redefining the treatment of LSS for patients. This Level 1 evidence-based procedure is supported by data from patients who reported successful outcomes up to five years.
How it works
The Vertiflex Procedure treats the root cause of pain by lifting pressure from the nerve roots at the affected segment.
Why choose the Vertiflex Procedure
For patients with moderate LSS, the Vertiflex Procedure is designed to provide clinically proven, long-term relief.
Key features:
- Allows for indirect decompression of the nerves while preserving the sagittal balance of the spine
- Backed by 5-year Level 1 Randomized Control Trial (RCT) and real-world data1-5
- Only standalone interspinous spacer FDA approved to treat moderate LSS
- Clinically proven to treat all forms of moderate LSS: central, lateral and foraminal
- As a reversible procedure, all future surgical options remain open
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Featured clinical publications
The Vertiflex Procedure is backed by 5-year Level 1 evidence to treat all forms of moderate LSS without fusion while maintaining sagittal alignment of the spine.3,4,5 Extensive clinical data demonstrates the Vertiflex Procedure delivers 66% back pain improvement, 75% leg pain improvement, 85% opioid reduction, and 90% patient satisfaction.3,4
The prospective Vertiflex Procedure Registry confirmed high patient satisfaction from the Randomized Controlled Trial (RCT), including 80% patient satisfaction at 12 months.5§
Vertiflex Procedure Clinical Data
Robust clinical evidence shows that the Vertiflex Procedure is an excellent choice for patients with moderate LSS.
Technical specifications
Specifications | Feature |
---|---|
8mm | Gold |
10mm | Blue |
12mm | Magenta |
14mm | Bronze |
16mm | Green |
Ordering information
UPN | DESCRIPTION |
---|---|
101-9808 | Superion Indirect Decompression System 8MM, VF Implant (Gold) |
101-9810 | Superion Indirect Decompression System 10MM, VF Implant (Blue) |
101-9812 | Superion Indirect Decompression System 12MM, VF Implant (Magenta) |
101-9814 | Superion Indirect Decompression System 14MM, VF Implant (Bronze) |
101-9816 | Superion Indirect Decompression System 16MM, VF Implant (Green) |
102-9800 | Superion Indirect Decompression System Kit, VF Instrument |
140-9800 | The Vertiflex Procedure Instrument Platform, VF Instrument |
Training for the Vertiflex Procedure
Education for Physicians Trained in the Vertiflex Procedure
All physicians must complete in person training provided by Boston Scientific to perform the Vertiflex Procedure. The video series below is intended to provide supplemental education on the Vertiflex Procedure and is not a replacement for official training.
Duration: 38:43
Date: November 2023
Resources
To explore our comprehensive portfolio of therapies for chronic pain, visit BostonScientific.com/Pain.
For reimbursement support, access coding and payment guides.
For Advanced Practice Provider education and support, view resources.
† The Superion Indirect Decompression System (IDS)
§ At 12 months and from the population that completed the follow-up
Results from different clinical investigations are not directly comparable. Information provided for educational purposes only.
Results from clinical studies are not predictive of results in other studies. Results in other studies may vary.
References:
- Patel VV, Whang PG, Haley TR, Bradley WD, Nunley PD, MilPatel VV, Whang PG, Haley TR, Bradley WD, Nunley PD, Davis RP, Miller LE, Block JE, Geisler FH. Superion interspinous process spacer for intermittent neurogenic claudication secondary to moderate lumbar spinal stenosis: two-year results from a randomized controlled FDA-IDE pivotal trial. Spine (Phila Pa 1976). 2015 Mar 1;40(5):275-82.
- Patel VV, Whang PG, Haley TR, Bradley WD, Nunley PD, Miller LE, Block JE, Geisler FH. Two-year clinical outcomes of a multicenter randomized controlled trial comparing two interspinous spacers for treatment of moderate lumbar spinal stenosis. BMC Musculoskelet Disord. 2014 Jul 5;15:221.
- 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)
- 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. (N = 107)
- Whang P, Antony A, Chen L, et al. Biomechanical Impact of Interspinous Spacers on Sagittal Alignment in Patients with Lumbar Spinal Stenosis [Abstract]. Twenty-Fifth Annual Meeting of the North American Neuromodulation Society, January 13-15, 2022, Orlando, FL USA.