MINNETONKA, Minn.--(BUSINESS WIRE)--Anulex Technologies, Inc. announced that two-year results from the largest prospective, multi-center randomized study of anular repair post-lumbar discectomy, were published in Spine. The Level 1 study showed patients with predominant leg pain who received the XcloseTM Tissue Repair System experienced a reduction in the need for subsequent reherniation surgery, 83% & 71%, at three and six months respectively, while retaining the benefits of discectomy procedures.
According to the published paper, the results were as follows:
“Patient symptoms were improved after surgery in an equivalent manner in both study groups. In the overall study analysis, the rate of reherniation surgery was lower for Xclose patients at all follow-up time points, but these differences were not statistically significant. In patients with predominant leg pain, there was a significant reduction in reherniation risk at 3 and 6 months post-operation for patients receiving Xclose. A positive reduction was maintained through 2 years, with a clinically relevant risk reduction of 45%, although not statistically significant. Safety was demonstrated with similar improvements in patient outcomes and no difference in reported adverse events.”
“Surgeons have always been concerned about leaving the anulus in a compromised state following discectomy procedures and are well aware that reherniation can be an unfortunate complication in 7-14% of previously successful surgical decompressions that include anulotomies. This study showed the Xclose System provides a solution for closing this important tissue plane,” said lead author Dr. Alexander Bailey of Precision Spine & Orthopaedic Specialists, Overland Park, KS.
He goes on to say: “This study highlights the potential viability of anular closure for the advancement of discectomy procedures using a method that does not add time or complexity to discectomy procedures.”
About Anulex Technologies, Inc.
Anulex Technologies, Inc. is dedicated to the development and commercialization of unique and proprietary soft tissue repair and fixation products. The Xclose System received FDA clearance and CE Mark for the approximation of soft tissue in general and orthopedic surgery. Anulex has submitted an application to the FDA for approval/clearance for increased specificity to the product label that would include the specific anatomy and additional claims defined in this paper. More information on the Company can be found at www.anulex.com.
Xclose and Anulex are trademarks of Anulex Technologies, Inc.