Newest Examine Printed in Journal of Scientific Neurosurgery provides to Sturdy Physique of Proof Supporting Tissue-Sparing Posterior Cervical Fusion to Deal with Excessive-Threat Cervical Fusion Sufferers
PLEASANTON, Calif., Dec. 7, 2023 /PRNewswire/ — Windfall Medical Expertise, Inc., a medical machine innovator centered on enhancing surgical outcomes for high-risk spine surgical procedure sufferers, right now introduced a brand new publication within the Journal of Scientific Neuroscience. Dr. Michael M. Haglund and colleagues authored the publication on the long-term outcomes of sufferers present process tissue-sparing Posterior Cervical Fusion (PCF) to revise a 1-level pseudarthrosis following a failed Anterior Cervical Discectomy and Fusion (ACDF).
There are over 300,000 cervical fusion procedures carried out every year, with over 40% involving sufferers with some type of threat components for nonunion. Whereas secure and efficient for many sufferers, a standard complication is pseudarthrosis, a failure of the bones to heal and fuse after surgical procedure. Threat components that contribute to pseudarthrosis embrace multi-level illness, poor bone high quality, smoking, diabetes, and inadequate immobilization. When pseudarthrosis happens, sufferers can expertise extreme ache and neurological points, which frequently necessitate one other surgical intervention. This second “revision” surgical procedure might be extra advanced and carry elevated dangers and issues.
The Journal of Scientific Neuroscience publication presents long-term information on forty-five sufferers enrolled from six websites throughout the USA who had a failed cervical fusion surgical procedure (ACDF) and had been subsequently revised with a tissue-sparing posterior cervical fusion utilizing Windfall Medical Expertise’s CORUS™ Spinal System and CAVUX® FFS.
Key findings from the examine embrace:
Excessive Success Charge: Surgeons noticed full fusion (bone therapeutic) in 91% of instances. An impartial core imaging lab noticed movement lower than two levels in 93% of instances and verified steady bridging bone throughout the handled joints in 80% of sufferers.
Excessive Satisfaction Charge: 74% of topics reported satisfaction with their revision surgical procedure outcomes.
Lowered Surgical procedure Time, Blood Loss, & Hospital Keep: Tissue-sparing PCF had a median process time of 49 minutes, an estimated blood lack of simply 10 cc, and a median hospital keep of in the future.
No Hospital Re-admission or Subsequent Surgical Interventions: Not one of the sufferers within the examine went on to an extra surgical procedure or re-admission following their tissue-sparing revision process with a median follow-up time of over three years.
CAVUX® FFS is a novel surgical implant constructed of a CAVUX Cervical Cage and an ALLY® Bone Screw. Two FFS units are implanted bilaterally via the again of the neck and span the side joints to supply immobilization and stabilization as an adjunct to posterior cervical fusion. 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 FFS is implanted utilizing the corporate’s flagship CORUS™ Spinal System, which allows a surgeon to carry out a tissue-sparing posterior cervical fusion earlier than putting implants.
“Tissue-sparing posterior cervical fusion with CORUS™ Spinal System and CAVUX® FFS has change into my most popular method to treating sufferers after a failed anterior fusion,” mentioned Dr. Michael M. Haglund, Endowed Professor of Neurosurgery and Orthopaedic Surgical procedure at Duke College and lead creator of the publication. “I’m happy to publish this new proof demonstrating constructive outcomes on this troublesome to deal with affected person inhabitants.”
“Failed spine surgical procedure is a large drawback for everybody concerned,” Windfall CEO and Co-founder Jeff Smith famous. “Excessive-risk spinal fusion sufferers endure nonunion charges a lot larger than most individuals notice and infrequently require revision surgical procedure. We imagine this isn’t acceptable and are pushed to forestall these failures for all sufferers. Our tissue-sparing posterior fusion expertise is a superb choice to deal with these sufferers, as is properly demonstrated on this examine. We additionally imagine one of the simplest ways to repair surgical failures amongst high-risk spinal fusion sufferers is to forestall them from taking place within the first place. We look ahead to sharing our FUSE examine information within the coming months for this software. I’m so grateful for the help of all of our analysis companions for each of those research. They’re actually devoted to fixing this unmet scientific want for high-risk sufferers.”
Windfall Medical Expertise units have been used to deal with over 20,000 sufferers and are at the moment out there in over 2,500 hospitals in the USA.
About Windfall Medical Expertise, Inc.
Windfall Medical Expertise, Inc. is a privately held medical machine firm centered on revolutionary and tissue-sparing surgical options for cervical spine surgical procedure. Its objective is to enhance scientific outcomes for high-risk sufferers and forestall surgical failures of the cervical spine. Its mission is to determine Circumferential Cervical Fusion (CCF) as the usual of look after high-risk sufferers. The Firm has pioneered a proprietary method to posterior cervical and lumbar fusion and has developed surgical instrumentation and implants that deal with the unmet scientific want of and provide distinctive advantages to the $2 billion worldwide cervical spine market.
The Windfall household of merchandise contains the CORUS™ Spinal System, CAVUX® intervertebral implants, and ALLY® bone and side screws. All implants and devices are sterile-packaged and single-use to maximise perioperative effectivity and guarantee constant high quality and efficiency.
View the scientific publication: Lengthy-term outcomes in sufferers handled with tissue-sparing posterior cervical fusion to revise a 1-level pseudarthrosis following ACDF