Advantages Of Safe Orthopaedics Sterile Single-Use Instrumentation For Lumbar Fusion Confirmed In A U.S. Clinical Study
Published: Jul 22, 2015
ERAGNY-SUR-OISE, France--(BUSINESS WIRE)--Regulatory News:
“Risk of infection following posterior instremented lumbar fusion of degenerative spine disease in 817 consecutive cases”
SAFE ORTHOPAEDICS (Euronext: FR0012452746 – SAFOR), a company developing and marketing an innovative range of sterile implants combined with their single-use surgical instruments, today announces the positive outcomes of a retrospective clinical study carried out by Dr. Gregory Lanford, neurosurgeon at St.Thomas Hospital for Specialty Surgery, Nashville, TN.
Dr. Lanford said: “Safe Orthopaedics’ Sterispine™ is a cost-effective system that negates the need for sterilization and potentially lowers the infection rate by mitigating risks for cross-contamination. The instruments are easy to use by any surgeon experienced in pedicle screw fixation.”
A total of 45 patients were operated on completing an instrumented lumbar fusion via an open or percutaneous approach using Sterispine kits by the author between July of 2013 and January of 2015. A 3 to 12 months follow-up period has been performed for each patient with plain radiograph at 1, 3, 6 and 12 months.
No cases of infection nor morbidity or mortality were reported while the infection rate for instrumented lumbar fusion is commonly found in the literature at 3-6% with a peak at two weeks post-op1.
Tim Nye, Safe Orthopaedics US Vice President, added: “This study is an important milestone as it highlights the potential benefits of using Safe Orthopaedics products. We are very thankful to Dr. Lanford for this important work.”
About Safe Orthopaedics
Founded in 2010, Safe Orthopaedics is a French medical technology company that develops and markets an innovative range of sterile implants and associated single-use surgical instruments, with the aim of facilitating safer, optimized and lower-cost spinal surgery. By avoiding the reuse of surgical instruments, Safe Orthopaedics reduces the risk of infection, avoids the cumbersome and unreliable logistics of instrument sterilization, and limits hospital costs. Protected by 17 patent families, the company’s CE-marked and FDA-approved SteriSpineTM kits are already being marketed in 12 countries, in Europe and the United States. They are being rapidly adopted by surgeons throughout the world, with nearly 1,000 procedures performed in 2014 and 1,143 in the first half of 2015 alone. The company is based at Eragny-sur-Oise (France), and has 33 employees and a US subsidiary.
For more information, visit: www.SafeOrtho.com
This press release contains certain forward-looking statements concerning Safe Orthopaedics and its business. Such forward-looking statements are based on assumptions that Safe Orthopaedics considers to be reasonable. However, there can be no assurance that the anticipated events contained in such forward-looking statements will occur. Forward-looking statements are subject to numerous risks and uncertainties including the risks set forth in the registration document of Safe Orthopaedics registered by the French Financial Markets Authority (Autorité des marchés financiers) on January 12, 2015 under number I.15-003 (a copy of which is available on www.safeorthopedics.com) and to the development of economic conditions, financial markets and the markets in which Safe Orthopaedics operates. The forward-looking statements contained in this press release are also subject to risks not yet known to Safe Orthopaedics or not currently considered material by Safe Orthopaedics. The occurrence of all or part of such risks could cause actual results, financial conditions, performance or achievements of Safe Orthopaedics to be materially different from such forward-looking statements.
This press release and the information that it contains do not constitute an offer to sell or subscribe for, or a solicitation of an offer to purchase or subscribe for, Safe Orthopaedics shares in any country.
1 Kaison L. Chaichana, MD, Mohamad Bydon, MD, David R. Santiago-Dieppa, MD, Lee Hwang, MD, Gregory McLoughlin, MD, Daniel M. Sciubba, MD, Jean Paul Wolinsky, MD, Ali Bydon, MD, Ziya L. Gokaslan, MD, and Timothy Witham, MD “Risk of infection following posterior instremented lumbar fusion of degenerative spine disease in 817 consecutive cases” Journal of Neurosurgery: Spine Jan. 2014/Vol. 20/No. 1/pages 45-52
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