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Vertiflex Procedure indirect decompression system spacers.

Clinical Data on the Vertiflex™ Procedure†

The Vertiflex Procedure is supported by 5-year Level 1 evidence to treat all forms of moderate Lumbar Spinal Stenosis (LSS) without fusion while maintaining sagittal alignment.1,2,3

Randomized controlled trial

The Vertiflex Procedure is supported by a 5-year Level 1 RCT that established our extensive clinical evidence: 

Data showing level 1 RCT results of 66% back pain improvement and 75% leg pain improvement.
66% Back Pain Improvement and 75% Leg Pain Improvement Infographic.

66% Back Pain Improvement

Graph showing VAS score for back pain improvement of 66% over five follow-up interval years.

75% Leg Pain Improvement

Graph showing VAS score for leg pain improvement of 75% over five follow-up interval years.

85% Opioid Reduction

Graphs showing a reduction of opioid prevalence from 49.5% to 7.5% over five follow-up interval years.

90% Patient Satisfaction

Graph showing ZCQ patient satisfaction scores at 90% patient satisfaction over five follow-up interval years.

The RCT demonstrated effectiveness for all types of moderate LSS: Central, Lateral and Foraminal

LSS is a common problem

Patients with LSS experience pain while standing or walking, weakness or balance issues, loss of sensation, and tingling or cramping in the buttocks or legs, with or without accompanying back pain. LSS patients often find relief by leaning forward or sitting to ease the pressure on nerves in the spine. The Vertiflex Procedure treats the root cause of pain by lifting pressure from the nerve roots at the affected segment. For patients with moderate LSS, the Vertiflex Procedure is designed to provide clinically proven, long-term relief.

LSS patient types

Pie chart of LSS patient types. 53% central only. 35% lateral only. 8% foraminal only. 4% central and lateral stenosis.

Lumbar Spinal Stenosis (LSS): Central, lateral and foraminal

Diagram of central, lateral and foraminal spinal stenosis location.

Real-world outcomes

The prospective Vertiflex Procedure Registry confirmed the high patient satisfaction from the RCT.

80% Patient satisfaction§,³

Graph showing average patient satisfaction in percentage averages from 89% at 3 weeks, 8-% at 6 months and 80 percent over 12 months.

Robust clinical evidence shows that the Vertiflex Procedure is an excellent choice for patients with moderate LSS

† The Superion Indirect Decompression System (IDS)

* Study completers at 5 years when compared to baseline scores

+ decrease in the proportion of patients using opioids compared to baseline at 5 years

§ 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.

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)

2. 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)

3. Whang P, Antony A, Chen L, Jain R. Biomechanical Impact of Interspinous Spacers on Sagittal Alignment in Patients with Lumbar Spinal Stenosis. NANS Annual Meeting 2022. (N = 190)

4. Tekmyster G, Sayed D, Cairns KD, Raso LJ, Kim C, Block JE. Interspinous Process Decompression With The Superion Spacer For Lumbar Spinal Stenosis: Real-World Experience From A Device Registry. Med Devices (Auckl). 2019;12:423-427. (N = 368)