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Classified in: Health
Subject: FDA

Providence Medical Technology, Inc. Announces FDA Clearance of CORUStm Navigation Access System for Use with Medtronic's StealthStationtm Surgical Navigation in Posterior Spinal Fusion


PLEASANTON, Calif., June 13, 2024 /PRNewswire/ -- Providence Medical Technology, Inc., an innovator in solutions for spinal surgery, announces that the U.S. Food and Drug Administration (FDA) has cleared the use of the CORUStm Navigation Access System for use with the CORUS Spinal System during spinal surgery. The CORUS Navigation Access System is specifically designed for use with Medtronic's StealthStationtm System for posterior spinal fusion procedures. This FDA clearance strengthens Providence Medical Technology's portfolio and underscores its commitment to advancing spinal surgery for high-risk spinal fusion patients. 

The CORUStm Navigation Access System is intended to assist surgeons in locating, accessing, and preparing facet joints for posterior fusion procedures. It enables surgeons to utilize surgical navigation to perform procedures with its novel CORUS Spinal System. Surgical guidance and navigation have become increasingly utilized in spinal surgical procedures, particularly for less invasive surgical techniques.

The potential benefits of utilizing the CORUStm Navigation Access System to perform a navigated CORUS fusion include:

Bryan Lee, MD, a neurosurgeon at Barrow Neurological Institute, commented, "The newly released CORUS navigation system offers simplicity and accuracy for placement of CAVUX® FFS-LX implants and provides the surgeon with a truly minimally invasive approach for posterior fusion, with a wide array of indications, including advanced disc degeneration and adjacent segment disease."

"We are thrilled to integrate our CORUStm Spinal System with the leading surgical navigation platform and allow for incredible precision and safety in posterior fusion surgeries," said Jeff Smith, CEO of Providence Medical Technology. "This clearance signifies another leap forward in our mission to improve clinical outcomes for high-risk patients and prevent surgical failures of the spine."

For more information about the CORUStm Navigation Access System please visit providencemt.com.

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. View product safety information: providencemt.com/safety

About Providence Medical Technology, Inc.

Providence Medical Technology, Inc. is a leading medical device company focused on advancing spine surgery technologies. Its commitment to improving clinical outcomes and reducing failures in high-risk spinal surgery has led PMT to develop a range of innovative solutions like CORUStm Spinal Systems, CAVUX® Facet Fixation Systems, and ALLY® Bone Screws and Facet Screws.

Indications for use:

The CORUStm Navigation Access System for use with the CORUStm Spinal System is intended to be used during spinal surgery to assist the surgeon in locating and preparing facet joints in either open or minimally invasive procedures. The CORUStm Navigation Access System is specifically designed for use with the Medtronic StealthStationtm System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a long bone, or vertebra can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy.

CORUStm Spinal System-X is a set of instruments indicated to be used to perform posterior cervical fusion in patients with cervical degenerative disc disease.

CORUStm Spinal System-LX is a set of instruments indicated to be used to perform posterior lumbar fusion in patients with lumbar degenerative disc disease.

CAVUX® Facet Fixation System (CAVUX FFS) is an integrated construct comprised of a CAVUX Cage and a single ALLY Bone Screw. CAVUX FFS is placed bilaterally through a posterior surgical approach and spans the interspace with points of fixation at each end of the construct. CAVUX FFS is intended for temporary stabilization as an adjunct to posterior cervical fusion in skeletally mature patients. CAVUX FFS is indicated for patients requiring a revision for an anterior pseudarthrosis at one level, from C3 to C7, with autogenous and/or allogenic bone graft.

CAVUX Facet Fixation System, Lumbar (CAVUX FFS-LX) is an integrated construct comprised of a CAVUX Cage and an ALLY Bone Screw. CAVUX FFS-LX is placed bilaterally through a posterior surgical approach and spans the facet interspace with points of fixation at each end of the construct. CAVUX FFS-LX is intended to provide temporary stabilization as an adjunct to a 1 or 2 level interbody lumbar fusion with autogenous and/or allogenic bone graft and must be accompanied with an FDA-cleared intervertebral body fusion device implanted at the same spinal level(s), and may be used with a pedicle screw and rod system implanted at the same spinal level(s). CAVUX FFS-LX is indicated for the treatment of patients with lumbar degenerative disc disease (DDD) from L4 to S1 in skeletally mature patients who have failed conservative care.

SOURCE Providence Medical Technology, Inc.


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