Gold 8MM Superion Indirect Decompression System implant for the Vertiflex Procedure.

The Vertiflex™ Procedure† Superion™ Indirect Decompression System

Name: The Vertiflex Procedure Superion Indirect Decompression System
Brand: Boston Scientific

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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Instructions for use are found inside the product packaging and on our product literature website.

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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. 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.

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 data^1-5
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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The Vertiflex Procedure Demonstrates 5-Year Durability

The VertiflexProcedure 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 Vertiflex Procedure Demonstrates Significant Real-World Outcomes

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.

Discover Vertiflex Procedure data

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.

The Vertiflex Procedure and Superion Indirect Decompression System.

Vertiflex Procedure Technique

Duration: 38:43

Date: November 2023

Explore Vertiflex Procedure educational resources on EDUCARE

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.

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