Solving challenges of adult spinal deformity procedures
Discover the LigaPASS™ 2.0 ligament augmentation system.
LigaPASS™ 2.0 ligament augmentation system
Ligament augmentation is an innovative surgical procedure that provides strength to the upper instrumented vertebra (UIV) and adjacent segments while also reducing junctional stress at those levels.
LigaPASS™ 2.0 ligament augmentation system is the first FDA cleared device for ligament augmentation for spinal surgeons to address some of the biggest adult deformity challenges.
79%
fewer PJF
reoperations
in a retrospective
case series
Clinical evidence for ligament augmentation
In a retrospective study of 242 cases where surgeons of a single institution incorporated ligament augmentation in their practice, their cases showed at one-year follow-up:
- Significantly lower rates of proximal junctional failure (PJF) reoperations, from 15.6% to 3.3% (p<0.001)1
- Significantly lower rates of PJF for upper thoracic instrumented vertebrae (UIV) constructs, from 6.7% to 1% (p<0.014)1
- Significantly lower rates of PJF for lower thoracic UIV constructs, from 21.3% to 5.3% (p<0.001)1
Leverage ligament augmentation benefits.
These data support the implementation of ligament augmentation in surgery for adult spinal deformity (ASD), particularly in patients where junctional strength is needed.
- Postoperative rates of PJK vary depending on the definition, from 17% to 69%.2,5
- Reports show that PJK onset occurs early after the operation, with 66% of cases observed within the first three months, and 80% within the first 18 months.2
- In the study where 69% of patients developed PJK, 3.4% of those patients progressed to PJF at one year, 5.3% in the second year, and 4.3% in the third year.5
- In a retrospective and comparative study of 195 patients at a single institution, patients treated with ligament augmentation technique were shown to have a significantly lower rate of reoperation due to PJF (OR 0.196, 95% CI 0.050–0.774; p = 0.020) and its associated hospital costs3, which can be more than $50,000 per procedure4 (study of 2003-2013 surgery outcomes; costs not standardized to a year).
$50K+
Estimated cost
for PJF
reoperation
Benefit from the comprehensive Medtronic ecosystem.
Ligament augmentation technique uses a combination of Medtronic technologies for execution and offers a solution tailored to each patient’s unique anatomy at all perioperative stages.
- LigaPASS™ 2.0 spinal system is indicated for ligament augmentation when needed and offers surgeons the ability to provide additional stability to the junction between instrumented and adjacent non-instrumented levels. LigaPASS™ 2.0 medial open connector accommodates band passage through spinous processes and lessens the associated risks of multiple sublaminar band passes.
- Stealth-Midas™ MR8™ drill system is engineered to deliver smooth, precise bone cutting, and to provide a better visualization during spinous process drilling.
- UNiD™ ASI supports your surgical strategy with the power of AI and predictive analytics.
- CD Horizon™ Solera™ spinal system facilitates surgeon choice and flexibility across patient types with a variety of implant options for treating multiple spinal pathologies with one system.
- Magnifuse™ bone graft offers a 100% allograft demineralized bone matrix in a resorbable mesh bag. The mesh bag helps prevent graft migration and provides graft containment.
LigaPASS™ 2.0 system
medial open connector
A parallel ligament connector designed for ligament augmentation procedures
Pair with the LigaPASS™ 2.0 system single band through the spinous process to offer additional stability at adjacent segments and lessen the associated risks of multiple sublaminar band passes.
Learn about LigaPASS™2.0 spinal system.
See how the LigaPASS™ 2.0 spinal system offers connection and correction options for spinal deformity pathologies.
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Risk statement
Possible undesirable effects
In addition to the risks associated with surgery of the spine without instrumentation, a number of possible adverse events may occur with posterior instrumented surgery, including but not limited to:
- Detachment, deformation, mobilization, slipping, breakage of one or all of the components
- Pain due to the surgery, fracture, deformation, and or migration of an implant
- Fracture of vertebrae
- Postoperative loss of correction and/or reduction of the spine, partial or total loss of the corrections achieved
1
Safaee MM, Haddad AF, Fury M, Maloney PR, Scheer JK, Lau D, Deviren V, Ames CP. Reduced proximal junctional failure with ligament augmentation in adult spinal deformity: a series of 242 cases with a minimum 1-year follow-up. J Neurosurg Spine. 2021;20;35(6):752–760.
2
Safaee MM, Deviren V, Dalle Ore C, et al. Ligament augmentation for prevention of proximal junctional kyphosis and proximal junctional failure in adult spinal deformity. J Neurosurg Spine. 2018;28(5):512–519.
3
Safaee MM, Dalle Ore CL, Zygourakis CC, Deviren V, Ames CP. The unreimbursed costs of preventing revision surgery in adult spinal deformity: analysis of cost-effectiveness of proximal junctional failure prevention with ligament augmentation. Neurosurg Focus. 2018;44(5):E13.
4
Theologis AA, Miller L, Callahan M, et al. Economic impact of revision surgery for proximal junctional failure after adult spinal deformity surgery: a cost analysis of 57 operations in a 10-year experience at a major deformity center. Spine. 2016;41(16):E964–E972. doi: 10.1097/BRS.0000000000001523.
5
Segreto, Frank A., et al., Incidence of acute, progressive, and delayed proximal junctional kyphosis over an 8-year period in adult spinal deformity patients. Operative Neurosurgery 18.1 (2020): 75-82.