PLEASANTON, Calif., June 13, 2024 /PRNewswire/ — Windfall Medical Know-how, Inc., an innovator in options for spinal surgical procedure, proclaims that the U.S. Food and Drug Administration (FDA) has cleared using the CORUS™ Navigation Entry System to be used with the CORUS Spinal System throughout spinal surgical procedure. The CORUS Navigation Entry System is particularly designed to be used with Medtronic’s StealthStation™ System for posterior spinal fusion procedures. This FDA clearance strengthens Windfall Medical Know-how’s portfolio and underscores its dedication to advancing spinal surgical procedure for high-risk spinal fusion sufferers.
The CORUS™ Navigation Entry System is meant to help surgeons in finding, accessing, and making ready aspect joints for posterior fusion procedures. It permits surgeons to make the most of surgical navigation to carry out procedures with its novel CORUS Spinal System. Surgical steering and navigation have grow to be more and more utilized in spinal surgical procedures, notably for much less invasive surgical methods.
The potential advantages of using the CORUS™ Navigation Entry System to carry out a navigated CORUS fusion embrace:
- Enhanced accuracy and precision with surgical devices and spinal implants, e.g., CAVUX FFS-LX.
- Improved visualization of the aspect joints and different anatomical buildings throughout procedures.
- Diminished threat of issues and shorter operative time.
Bryan Lee, MD, a neurosurgeon at Barrow Neurological Institute, commented, “The newly launched CORUS navigation system gives simplicity and accuracy for placement of CAVUX® FFS-LX implants and supplies the surgeon with a really minimally invasive strategy for posterior fusion, with a big selection of indications, together with superior disc degeneration and adjoining section illness.”
“We’re thrilled to combine our CORUS™ Spinal System with the main surgical navigation platform and permit for unbelievable precision and security in posterior fusion surgical procedures,” mentioned Jeff Smith, CEO of Windfall Medical Know-how. “This clearance signifies one other leap ahead in our mission to enhance scientific outcomes for high-risk sufferers and forestall surgical failures of the spine.”
For extra details about the CORUS™ Navigation Entry System please go to providencemt.com.
As with all medical units, there are dangers and concerns to machine use. Please consult with the machine labeling for a full dialogue of potential dangers, contraindications, warnings, precautions, and directions to be used. Rx solely. View product security data: providencemt.com/security
About Windfall Medical Know-how, Inc.
Windfall Medical Know-how, Inc. is a number one medical machine firm centered on advancing spine surgical procedure applied sciences. Its dedication to enhancing scientific outcomes and lowering failures in high-risk spinal surgical procedure has led PMT to develop a spread of progressive options like CORUS™ Spinal Programs, CAVUX® Aspect Fixation Programs, and ALLY® Bone Screws and Aspect Screws.
Indications to be used:
The CORUS™ Navigation Entry System to be used with the CORUS™ Spinal System is meant for use throughout spinal surgical procedure to help the surgeon in finding and making ready aspect joints in both open or minimally invasive procedures. The CORUS™ Navigation Entry System is particularly designed to be used with the Medtronic StealthStation™ System, which is indicated for any medical situation by which using stereotactic surgical procedure could also be applicable, and the place reference to a inflexible anatomical construction, akin to an extended bone, or vertebra might be recognized relative to a CT or MR-based mannequin, fluoroscopy photographs, or digitized landmarks of the anatomy.
CORUS™ Spinal System-X is a set of devices indicated for use to carry out posterior cervical fusion in sufferers with cervical degenerative disc illness.
CORUS™ Spinal System-LX is a set of devices indicated for use to carry out posterior lumbar fusion in sufferers with lumbar degenerative disc illness.
CAVUX® Aspect Fixation System (CAVUX FFS) is an built-in assemble comprised of a CAVUX Cage and a single ALLY Bone Screw. CAVUX FFS is positioned bilaterally by means of a posterior surgical strategy and spans the interspace with factors of fixation at every finish of the assemble. CAVUX FFS is meant for non permanent stabilization as an adjunct to posterior cervical fusion in skeletally mature sufferers. CAVUX FFS is indicated for sufferers requiring a revision for an anterior pseudarthrosis at one degree, from C3 to C7, with autogenous and/or allogenic bone graft.
CAVUX Aspect Fixation System, Lumbar (CAVUX FFS-LX) is an built-in assemble comprised of a CAVUX Cage and an ALLY Bone Screw. CAVUX FFS-LX is positioned bilaterally by means of a posterior surgical strategy and spans the aspect interspace with factors of fixation at every finish of the assemble. CAVUX FFS-LX is meant to offer non permanent stabilization as an adjunct to a 1 or 2 degree interbody lumbar fusion with autogenous and/or allogenic bone graft and should be accompanied with an FDA-cleared intervertebral physique fusion machine implanted on the identical spinal degree(s), and could also be used with a pedicle screw and rod system implanted on the identical spinal degree(s). CAVUX FFS-LX is indicated for the remedy of sufferers with lumbar degenerative disc illness (DDD) from L4 to S1 in skeletally mature sufferers who’ve failed conservative care.
SOURCE Windfall Medical Know-how, Inc.
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