A New Standard for 3-Level Cervical Fusion

CORUS™ PCSS for circumferential cervical fusion up to 3 levels.

Posterior Cervical Stabilization System (PCSS)

CORUS PCSS is posterior spinal instrumentation with integrated screw fixation intended to provide immobilization and stabilization of up to 3 consecutive levels of the cervical spine. PCSS is an adjunct to Posterior Cervical Fusion (PCF) and is intended to be used in combination with an Anterior Cervical Discectomy and Fusion (ACDF) at the same level(s).

CORUS PCSS with two fixation screws, lateral view

CORUS™ PCSS is an integrated construct comprised of a Cage and two Fixation Screws.

CORUS PCSS 3-level circumferential cervical fusion ACDF plus PCF

Superior Fusion Outcomes Faster*

12 months after surgery, patients treated with ACDF & CORUS PCSS demonstrated a clinically superior fusion rate compared to ACDF alone.*(1)

12-month CT scan showing fusion of the anterior column following CCF with PCSS.

Reduces Reoperation Rates

More than one in five 3-level ACDF patients require revision surgery within 24 months. Nonunion (symptomatic pseudarthrosis) is the #1 reason.(1)

Superior Safety Outcomes

Patients treated with ACDF and PCSS patients achieved greater composite safety success at 12 and 24 months than patients treated with ACDF alone.(1)

Key Clinical Evidence

From the largest prospective randomized clinical study evaluating 3-level ACDF versus 3-level CCF with PCSS.

i.e., 3-level Anterior Cervical Discectomy and Fusion versus 3-level Circumferential Cervical Fusion with CORUS Posterior Cervical Stabilization System (1)

Fusion Rates at 12 Months*

Chart showing 12-month fusion data comparing 3-level ACDF versus 3-level CCF with CORUS PCSS

* At 12 months, the primary endpoint of fusion success demonstrated a superior fusion rate for patients treated with ACDF and PCSS (CCF) compared to ACDF alone.

Composite Safety at 24 Months

Chart showing 24-month composite safety data comparing 3-level ACDF versus 3-level CCF with CORUS PCSS

A patient was considered a safety success only if all of the following component criteria were met at 24 months:

— Fusion success at all three levels;
— NDI success, defined as improvement in NDI Score of ≥ 15/50 points in patients with a ≥ 30/50 score at baseline or a 50% improvement in patients with a baseline NDI score of ˂30/50 points;
— Neurological success, defined as maintenance or improvement of neurological status; and
— Absence of secondary surgical interventions (SSI) at the index levels.

Adverse Events (AE)

Chart showing adverse event data comparing 3-level ACDF versus 3-level CCF with CORUS PCSS

CCF with PCSS did not increase the risk of Adverse Events (AE) compared to ACDF alone.

Secondary Surgical Interventions (SSI)

Chart showing secondary surgical interventions comparing 3-level ACDF to 3-level CCF with CORUS PCSS

Biomechanically Superior Stabilization for Achieving Fusion

Adding PCSS Cages to a plated ACDF reduces range of motion and increases segmental stability.(2)

ROM in degrees after single level C6–C7 instrumentation.

Chart showing the biomechanical stability of plated ACDF compared to ACDF plus CORUS PCSS (Posterior Cervical Stabilization System)

A Triforce of Fixation & Support

Leverages the stability of the anterior implant to create three points of fixation & support.

CORUS PCSS forms a Triforce of Stability to stabilize the cervical spine for fusion.

Tissue-Sparing Technique with Direct Visualization

CORUS™ Spinal System is used to access and prepare the site for posterior fusion. CORUS™ Spinal System consists of instruments for access, bone preparation and decortication, bone graft application, and implant delivery.

When combined with the DiViNE™ Portal System, it is designed to allow for a tissue-sparing technique with direct visualization of the surgical site.†

As with all medical devices, there are risks and considerations to device use. Please refer to the device labeling for a full discussion of potential risks, contraindications, warnings, precautions, and instructions for use. Rx only.

* At 12 months, the primary endpoint of fusion success demonstrated a superior fusion rate for subjects treated with ACDF and PCSS (CCF) compared to ACDF alone.(1)

† Posterior cervical fusion can be performed using open or tissue-sparing techniques. Tissue-sparing technique may require special training.

CLN-PMT-140 The REVISE Report, Rev 1, 04OCT2022 Safety and Effectiveness of a Posterior Cervical Stabilization System (PCSS) when used as an adjunct to Circumferential Cervical fusion for the treatment of multi-level cervical degenerative disease (FUSE) Study: An interim analysis of the FUSE Study Data (IDE G190235; NCT04229017)
Voronov LI, et al. Med Devices (Auckl). 2016 Jul 13;9:223-30. doi: 10.2147/MDER.S109588. PMID: 27471414.

View Safety Information

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Indications for Use, CORUS™ PCSS:
CORUS™ Posterior Cervical Stabilization System (PCSS) is posterior spinal instrumentation with integrated screw fixation intended to provide immobilization and stabilization of spinal segments.
CORUS PCSS is placed through a posterior surgical approach in up to 3 consecutive levels of the cervical spine (C3-C7) and achieves bilateral facet fixation by spanning the facet interspace at each level with points of fixation at each end of the construct.
CORUS PCSS is intended as an adjunct to posterior cervical fusion (PCF) and is only intended to be used in combination with an anterior cervical discectomy and fusion (ACDF) at the same level(s).
CORUS PCSS is indicated for skeletally mature patients with degenerative disc disease (DDD). DDD is defined as radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies.
CORUS PCSS is to be used with autogenous bone and/or allogenic bone graft.

Device Description, CORUS™ PCSS:
CORUS™ PCSS is posterior spinal instrumentation with integrated screw fixation intended to provide immobilization and stabilization of spinal segments. The device is placed through a posterior surgical approach in up to 3 consecutive levels of the cervical spine (C3-C7) and achieves bilateral facet fixation by spanning the facet interspace at each level with points of fixation at each end of the construct.
The device is manufactured from medical grade titanium alloy (6Al4V) and supplied sterile for single use only with a pre-attached disposable delivery instruments. The implant is fenestrated and is to be used with autogenous bone and/or allogenic bone graft. The design incorporates “windows” through the implant to permit visualization of the graft material and, over time, formation of new bone.
CORUS™ Spinal System is used to access and prepare the site for posterior fusion.

Indications for Use, CORUS™ Spinal System-X
FOR CERVICAL FUSION: The CORUS™ Spinal System-X is a set of instruments indicated to be used to perform posterior cervical fusion in patients with cervical degenerative disc disease.

FOR LUMBAR FUSION: The CORUS™ Spinal System-X is a set of instruments indicated to be used to perform posterior lumbar fusion in patients with lumbar degenerative disc disease.

Intended Use and Indications, DiViNE Portal System
The DiViNE Portal System has applications for the creation and maintenance of an operative cavity to directly visualize an operating or examination area of the patient's body. The device may be used in all types of surgical procedures requiring retraction of tissue.

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