Device: Spine - Tenon Medical, Inc. Releases the Results of the First Post-Clearance Clinical Study
SAN RAMON, Calif., Feb. 10, 2020 /PRNewswire/ --
Tenon Medical, Inc., a manufacturer of instruments and implants for sacroiliac joint fusion surgery, today announced the completion of the first phase of its post-approval clinical study for the Catamaran™ Sacroiliac Joint Fixation System (CAT SIJ Fixation System) specifically indicated for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroilitis. The company received 510(k) clearance from the United States Food and Drug Administration (FDA) to market the device in the fall of 2018.
The results demonstrated greater than 85% reduction in SIJ pain at 6 weeks and radiographic evidence of the presence of solid continuous bridging bone across the treated joint at 6 months. No procedure- or device-related serious adverse events were reported.
A unique feature of the CAT SIJ Fixation System procedure is the ability to directly visualize the joint allowing for a significant increase in reimbursement for the surgeon and facility payments. "This single implant SIJ fusion system allows me to use either a navigated procedure or fluoroscopic imaging providing flexibility in access and visibility. The implant is designed to breach the SIJ and allow for bone graft materials to be loaded and delivered to the SIJ before and after implant placement to promote fusion of the SIJ. The unique trajectory eliminates the risk of sacral nerve root injury encountered with other fusion techniques and reduces the risk of entry into the retroperitoneal space. By supplementing fixation with decortication and bone grafting, I can be confident that my patients have the best possible foundation for biological fusion, and long-term relief," said Dr. Michael Chaparro.
"Our unique approach is designed to drastically reduce procedure time and represents a landmark innovation for SIJ fusion surgery benefiting patients, surgeons, facilities, and payers," said Dr. Kal Mentak, CEO of Tenon Medical.
In November 2016, Tenon Medical, Inc. was granted the first US patent covering a novel posterior approach SIJ fusion system. The company has since filed for additional compositions.
Tenon Medical, Inc. is a privately held company located in the San Francisco Bay Area.