New Study Shows Better Results with Combined Cervical Fusion Technique

FDA Greenlights New Cervical Fusion Technique

The FDA has approved the CORUS™ PCSS system for treating up to three levels of cervical Degenerative Disc Disease (DDD). This approval is based on findings from the FUSE study, which compared the combined approach of Circumferential Cervical Fusion (CCF) with Anterior Cervical Discectomy and Fusion (ACDF) alone.

The FUSE study involved 227 patients across 18 U.S. sites. It showed that the CCF approach using the CORUS™ PCSS system resulted in more successful outcomes compared to ACDF alone, especially in high-risk cases.

Study Results and Implications

The study's interim analysis revealed that CCF offered higher fusion success rates and better symptom relief than ACDF alone. Patients treated with CCF reported significant improvements in their symptoms and overall quality of life.

The CCF approach also showed lower rates of secondary surgeries compared to ACDF alone. Only 1.7% of CCF patients needed additional surgery, compared to 22.8% of those who underwent ACDF alone.

Expert Opinions

Dr. Pierce D. Nunley, a lead investigator of the study, highlighted the compelling evidence supporting CCF. He noted the higher fusion rates and the remarkable improvements in patient-reported outcomes as key reasons to consider CCF.

Jeff Smith, CEO of Providence Medical Technology, echoed these sentiments. He emphasized that the study's findings represent a significant advancement in spinal surgery and urged for CCF with CORUS PCSS to become the new standard of care.

Conclusion

The FUSE study offers promising evidence that CCF with the CORUS PCSS system could redefine the treatment for multilevel cervical DDD. The higher success rates and fewer secondary surgeries point to significant benefits for patients.

This new approach could potentially improve the long-term outcomes for those suffering from this debilitating condition.