Technical Assessment of Tru-Fuse
December 2009
This Technical Assessment was prepared by the AANS Emerging Technology Committee using systematic review methodology, and summarizes the findings of studies published and other publicly available information as of December 2009 on Tru-Fuse by MinSURG Corporation. As a summary, this document does not make recommendations for or against the use of Tru-Fuse by MinSURG Corporation. It should not be construed as an official position of the American Association of Neurological Surgeons. Readers are encouraged to consider the information presented in this assessment and reach their own conclusions concerning the subject matter.
The American Association of Neurological Surgeons has developed and is providing this Technical Assessment as an educational tool. Patient care and treatment should always be based on a physician’s independent medical judgment given the individual patient’s clinical circumstances.
| Assessment Date |
Dec/2009 |
| Manufacturer |
MinSURG Corporation Clearwater, FL |
| Website |
http://www.trufuse.com/ |
| Stated Purpose |
Minimally Invasive Spinal Facet Fusion |
| Cost of Device |
$5,200 per level |
| FDA Approval |
Cortical Bone Screw 510(k), FDA approved as a bone graft to provide stability for primary and secondary healing of bone. |
| Usage History |
Introduced to US market in 2006. Company reports several thousand procedures covering all 50 states. |
| Current Providers |
Majority (60-70%) Pain Clinic Physicians, remainder divided between Ortho, PM&R, Neurosurgery. Company estimates that approximately 150 – 200 physicians have been trained. |
| Site of Service |
Ambulatory Surgery Center (>75%), some office, few inpatient. |
| Clinical Indications |
Facet arthrosis with spine pain |
| Diseases Treated |
Cervical, Thoracic and lumbar degenerative pain |
| Technique |
Allograft interference screw is percutaneuosly or through stab incision, inserted into the facet joint (cervical, thoracic, or lumbar) to stiffen the joint and promote fusion. |
| Supporting Literature |
No current publications in US literature. Two vendor sponsored unpublished articles are attached. |
| Vendor Suggested Coding |
Vendor suggests the use of 22600, 22610 or 22612 (posterior fusion cervical, thoracic or lumbar). Currently a Cat III tracking Code has been approved by CPT and is soon to be released. |
| Assessment |
FDA approved as a threaded bone dowel for minimally invasive bone fusion. This has been brought to market as a minimally invasive spinal fusion procedure. Marketing has been primarily aimed at non-surgeons in out patient pain clinic settings. There is no published data to assess safety, efficacy, or outcomes. Manufacturer sponsored literature has too many inconsistencies to be reliable in guiding therapy. In conclusion there is insufficient objective information to evaluate the safety and utility of this device or to make recommendations regarding clinical usage. |
| **The manufacturer has been contacted requesting any possible scientific data not identified in a literature search. |