Providence Medical Technology, Inc. Announces FDA Clearance of CORUS™ Navigation Access System for Use with Medtronic StealthStation™ Surgical Navigation in Posterior Spinal Fusion

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

The CORUS™ Navigation Access System is intended to help surgeons locate, access and prepare facet joints for posterior fusion procedures. It allows surgeons to use surgical navigation to perform procedures with its new CORUS spinal system. Surgical guidance and navigation are increasingly used in spinal surgical procedures, particularly for less invasive surgical techniques.

The potential benefits of using CORUS^™ The navigation access system for performing a navigated CORUS merger includes:

• Improved accuracy and precision with surgical instruments and spinal implants, for example CAVUX FFS-LX.
• Improved visualization of facet joints and other anatomical structures during procedures.
• Reduced risk of complications and shorter operating time.

Bryan LeeMD, neurosurgeon at Barrow Neurological Institute, commented: “The new CORUS navigation system provides simplicity and precision for CAVUX placement.^® FFS-LX implants and provides the surgeon with a truly minimally invasive approach to posterior fusion, with a wide range of indications, including advanced disc degeneration and adjacent segment disease.

“We are excited to integrate our CORUS™ spinal system with the leading surgical navigation platform and enable incredible precision and safety in posterior fusion surgeries,” said Jeff Smith, CEO of Providence Medical Technology. “This authorization represents another step forward in our mission to improve clinical outcomes for high-risk patients and prevent spinal surgical failures.”

For more information on the CORUS™ Navigation Access System, please visit providencemt.com.

As with all medical devices, there are risks and considerations associated with their use. Please refer to the device labeling for a complete 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 such as CORUS™ Spinal Systems, CAVUX® Facet Fixation Systems and Bone Screws. and ALLY® facet screws.

Indications for use:

The CORUS™ Navigation Access System for use with the CORUS™ Spinal System is intended for use during spine surgery to assist the surgeon in locating and preparing facet joints during open or minimally invasive procedures . The CORUS™ Navigation Access System is specifically designed for use with the Medtronic StealthStation™ System, which is indicated for any medical condition in which stereotactic surgery may be appropriate, and where reference to an anatomical structure rigid, such as a long bone. , or a vertebra can be identified against a model based on CT or MRI scans, fluoroscopy images, or digitized landmarks of the anatomy.

CORUS™ Spinal System-X is a set of instruments indicated for use in performing posterior cervical fusion in patients with cervical degenerative disc disease.

CORUS™ Spinal System-LX is a set of instruments indicated for use in performing posterior lumbar fusion in patients with lumbar degenerative disc disease.

The CAVUX® Facet Fixation System (CAVUX FFS) is an integrated construct consisting 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 fixation points at each end of the construct. CAVUX FFS is intended for temporary stabilization in addition to posterior cervical fusion in skeletally mature patients. CAVUX FFS is indicated in patients requiring revision for an anterior nonunion at one level, from C3 to C7, with autogenous and/or allogeneic bone graft.

The CAVUX Facet Fixation System, Lumbar (CAVUX FFS-LX) is an integrated construct consisting of a CAVUX cage and an ALLY bone screw. CAVUX FFS-LX is placed bilaterally through a posterior surgical approach and covers the interface space with fixation points at each end of the construct. CAVUX FFS-LX is intended to provide temporary stabilization as an adjunct to 1- or 2-level lumbar interbody fusion with autogenous and/or allogeneic bone graft and must be accompanied by an implanted, FDA-approved intervertebral body fusion device at the same level of the spinal column(s), and can be used with a system of pedicle screws and rods 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 not responded to conservative care.

SOURCE Providence Medical Technology, Inc.