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Indications, Safety and Warnings

Indications, safety, and warnings

Description

The LigaPASS™ MEDICREA™ INTERNATIONAL S.A.S. spinal system is composed of four components, a connector, two set screws and a band.

The LigaPASS™ system is designed to stabilize a vertebra in the same manner as a hook around the vertebra during development of solid bony fusion. The LigaPASS™ system must be implanted via a posterior approach to complete a thoraco-lumbar fixation system as the PASS LP™ MEDICREA™ INTERNATIONAL S.A.S. spinal system or CD Horizon™ spinal system.

The implants are manufactured in titanium alloy Ti-6Al-4V ELI conforming to ISO 5832-3 specifications and ASTM F136, with the exception of the band which is manufactured in polyethylene terephtalate (PET) and titanium T40 conforming to ISO 5832-2 specifications and ASTM F67.

As any orthopaedic implant, these implants must not be reused. For a complete guide of the system, please refer to surgical technique manual for specific instructions.

Indications

The LigaPASS™ system is an implant for use in orthopaedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use are as follows:

Spinal trauma surgery, used in sublaminar or facet wiring techniques;
Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis and kyphosis;
Spinal degenerative surgery, as an adjunct to spinal fusions;
Intended for use with a posterior spinal construct when ligament augmentation is needed.

The LigaPASS™ system may also be used in conjunction with other medical grade implants made of titanium or cobalt-chrome alloy whenever “wiring” may help secure the attachment of other implants.

WARNING: The system must not be used with rod diameters inferior to 4.5mm or superior to 6mm.

Risks

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, the 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.

LigaPASS™ 2.0
spinal system

LigaPASS™ 2.0 is a spinal system that offers connection and correction options for spinal deformity pathologies.

Download surgical technique

LigaPASS™ band threaded through a band connector

Overview

A dedicated option for spinal deformity-specific pathologies

For adult and pediatric cases

The LigaPASS™ 2.0 system is designed to help achieve a well-balanced spine in three planes: coronal, sagittal, and axial when screws, hooks, or wires cannot be placed.

LigaPASS™ 2.0 spinal system offers a broad range of four band connectors with two band options tailored to help meet various clinical needs.

Closed-design connector

Closed design for
correction maneuvers

Low-profile design for
neuromuscular deformities

Open design connector

Open design for existing
construct connection

Parallel ligament design connector

Parallel ligament design for
ligament augmentation

Connection

The LigaPASS™ 2.0 system of band connectors offer sublaminar, transverse process, and spinous process fixation in the thoracic and/or lumbar spine.

LigaPASS™ in spinal anatomy

Correction

LigaPASS™ 2.0 system connectors and bands may be used in posterior spinal constructs in conjunction with UNiD™ patient-specific implants and CD Horizon™ Solera™ 5.5/6.0mm spinal system, which offers a variety of implant options for spinal deformity correction.

LigaPASS™ and instrumentation in spinal anatomy

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