Abstract On Augmentation Of Prodisc(R) With CORTOSS(R) To Be Presented At SAS 2006 In Montreal.MALVERN, Pa. -- Orthovita, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on NM:VITA), a developer of orthopedic biomaterials, reported that James Yue, M.D., from Yale University School of Medicine, will present a scientific paper titled "A prospective, non-randomized analysis of the adjunctive use of CORTOSS(R) vertebroplasty in lumbar disc arthroplasty utilizing the Prodisc(R) prosthesis prosthesis (prŏs`thĭsĭs): see artificial limb. prosthesis Artificial substitute for a missing part of the body, usually an arm or leg. " at the SAS (1) (SAS Institute Inc., Cary, NC, www.sas.com) A software company that specializes in data warehousing and decision support software based on the SAS System. Founded in 1976, SAS is one of the world's largest privately held software companies. See SAS System. 2006 meeting being held in Montreal on May 13 at 11:20 a.m. in Session G, Innovative Technologies: Clinical Papers. The co-authors of this scientific paper include Dr. Rudolf Bertagnoli who is associated with the St. Elizabeth Klinikum, Straubing, Germany, as well as Andrea Fenk-Mayer, M.D., Richard Lee, M.D., Jessica Kirk, A.B., and Armin Karg, A.B. The expanded use of lumbar disc arthroplasty in osteopenic patients has not been advised due to the possibility of subsidence/compression fractures. This is because a significant number of women will develop osteoporosis, which makes them susceptible to suffering vertebral compression fractures in the future. Given that osteoporosis is a contra-indication for lumbar total disc arthroplasty, there may be a need for materials and techniques to prevent and treat subsidence in this patient group. Accordingly, the objective of the prospective, non-randomized study was to examine the use of adjunctive CORTOSS vertebroplasty in osteopenic patients undergoing Prodisc-L(R) surgery. The median age of all patients was 49 years old, and they presented with symptomatic lumbar degenerative disc disease Degeneration of the intervertebral disc, which is often called "degenerative disc disease" (DDD) of the spine, is a common disorder of the lower spine and for some people can cause low back pain and/or leg pain (sciatica). , with or without radicular pain. Post-operative follow-up with radiographic radiographic (rā´dēōgraf´ik), adj relating to the process of radiography, the finished product, or its use. analysis was performed at 3, 6 and 12 months. The 35 patients included in the analysis fulfilled all follow-up criteria and underwent a procedure that included both a Prodisc lumbar disc arthroplasty and an adjunctive anterior vertebroplasty using CORTOSS bone augmentation material. Statistically significant improvements in VAS vas (vas) pl. va´ sa [L.] vessel.va´sal vas aber´rans 1. a blind tubule sometimes connected with the epididymis; a vestigial mesonephric tubule. 2. , Oswestry and patient satisfaction scores occurred 3 months post-op, and these improvements were maintained 12 months post-op. No additional surgeries were necessary either at the affected or unaffected levels in vertebroplasty patients. There were no cases where neurologic adverse effects or hemodynamic he·mo·dy·nam·ics n. (used with a sing. verb) The study of the forces involved in the circulation of blood. he or pulmonary instability were experienced. In addition, there were no cases of subsidence, loosening or migration seen in patients undergoing adjunctive vertebroplasty. "Our early results indicate that adjunctive use of CORTOSS vertebroplasty during lumbar total disc arthroplasty in patients with less than optimal bone density appears to decrease the risk of subsidence as compared to historical controls," said Dr. Bertagnoli. A prospective, randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , controlled multi-center IDE study is underway in the U.S. designed to demonstrate that CORTOSS is safe and effective for the treatment of osteoporotic vertebral compression fractures. CORTOSS is not available for sale in the United States and is limited to investigational use. About the Company Orthovita is a biomaterials company with proprietary technologies for the development and commercialization of synthetic, biologically active, tissue engineering products for orthopedic and neurosurgical applications. Our products are used in the regeneration of bone and soft tissue. Our near-term commercial business is based on our VITOSS(R) Bone Graft bone graft Orthopedic surgery Sterilized bony tissue, often of cadaveric origin, used to fill and/or 'sculpt' bone defects Indications Spinal fusion, revision of failed articular prostheses, filling traumatic or malignant bone defects, or periodontal defects. Substitute technology platforms, which are designed to address the non-structural bone graft market by offering synthetic alternatives to the use of autograft autograft: see transplantation, medical. or cadaver-derived bone material to meet a broad range of orthopedic clinical needs in the spine, trauma, joint reconstruction, revision surgery and extremities markets, and VITAGEL(TM) Surgical Hemostat hemostat /he·mo·stat/ (he´mo-stat) 1. a small surgical clamp for constricting blood vessels. 2. an antihemorrhagic agent. he·mo·stat n. 1. , which is an adherent adherent /ad·her·ent/ (-ent) sticking or holding fast, or having such qualities. matrix and an impermeable impermeable /im·per·me·a·ble/ (-per´me-ah-b'l) not permitting passage, as of fluid. im·per·me·a·ble adj. Impossible to permeate; not permitting passage. barrier to blood flow. Our longer-term U.S. clinical development program is focused on our CORTOSS(R) Synthetic Cortical Bone technology platform, which is designed for injections in osteoporotic spines to treat vertebral compression fractures. Orthovita works jointly with Kensey Nash Corporation and Angiotech Pharmaceuticals, Inc., to develop and market novel synthetic-based biomaterial products, and continues to pursue similar relationships with other companies in biomaterials. This press release may contain forward-looking statements regarding Orthovita's current expectations of future events that involve risks and uncertainties, including, without limitations, our products and other aspects of our business. Such statements are based on management's current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption "Certain Risks Related to Our Business". Further information about these and other relevant risks and uncertainties may be found in Orthovita's filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements. |
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