MINNEAPOLIS–(BUSINESS WIRE)–Anulex Technologies, Inc., a privately held medical device manufacturer focusing on spinal disc Preservation & Anular RepairTM products, announced the completion of the patient enrollment phase of its XcloseTM Tissue Repair System Post Market Clinical Study. 750 patients from 34 facilities around the U.S. were enrolled in the study. These patients will be followed for a two year period.
This prospective, controlled, randomized study will compare discectomy patients that receive anular repair (utilizing XcloseTM) to those who have no repair. Primary study objective is to investigate the outcomes of surgical management of disc herniation in terms of rate of reherniation. Other outcomes measures such as pain relief, functional improvement, patient satisfaction, disc height and the economic benefits associated with return to work and healthcare utilization, will also be measured.
The Xclose system has been used in over 6,000 U.S. procedures to date. Xclose was cleared in September 2006 for use in soft tissue approximation for procedures such as general and orthopedic surgery. Xclose provides a simple, convenient method for treating the compromised soft tissue of the anulus fibrosus.
Commenting on these two milestones, Rich Lunsford, Anulex’s President and Chief Executive Officer, said, “The completion of the enrollment phase of this landmark study for anular repair is an important achievement. As the pioneer in anular repair, this study represents Anulex’s commitment to provide further evidence to support the benefits of preservation and repair of the anulus. In addition, we are proud that over 6,000 patients have been treated with the Xclose system and we look forward to continuing to address the unmet clinical need.”