LDR Spine Selects Dr. Ralph Rashbaum as Lead Clinician for Cervical Artificial Disc Study; Co-Founder of Texas Back Institute to Anchor Clinical Team for Second-Generation Artificial Disc FDA Study.AUSTIN, Texas -- LDR See photocell. Spine, a total spine solution company, today announced it has named Dr. Ralph Rashbaum, M.D. of the Texas Back Institute as the lead clinical investigator A clinical investigator involved in a clinical trial is responsible for ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under for its cervical artificial disc IDE study. This announcement follows the company's recent IDE (Investigational Device Exemption An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and ) submission for the clinical investigation that is required by the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. before the disc can be distributed or sold in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. . "In my practice at the Texas Back Institute, we see many patients that can benefit from artificial disc implantation under the right circumstances," said Dr. Rashbaum. "The Mobi-C is designed to be implanted just like a cervical cage and utilizes the same basic approach. The instrumentation is simple and elegant. Most importantly, the mobile bearing design may provide for some latitude in the placement of the device." "We are honored to have a surgeon as well-known and respected as Dr. Rashbaum," said Steve Whitlock, CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of LDR Spine. "His agreement to participate as our lead clinician is emblematic of the strong enthusiasm Mobi-C is generating in the spine surgeon community. The mobile bearing technology, overall design, and comprehensive instrumentation could potentially make the whole surgical process easier for surgeons." The Mobi-C device is limited to investigational use and not yet available for distribution in the United States. About Dr. Rashbaum Ralph Rashbaum, M.D. is the lead clinician for the Mobi-C(R) cervical artificial disc clinical study. He is a board-certified orthopedic surgeon with specialization in the spine and is co-founder of the Texas Back Institute, the largest freestanding spine specialty clinic in the United States. Dr. Rashbaum, an Assistant Clinical Professor at the University of Texas Southwestern Medical School Ranking and selectivity The medical school ranked 19th in the 2008 U.S. News and World Report ranking of the top medical schools in the research category (ranked 6th among public medical schools), ranked 18th in primary care category, and ranked 21st in terms of research in Dallas, is also a published author. He received his Doctor of Medicine degree from the Chicago Medical School The Chicago Medical School is the medical school of the Rosalind Franklin University of Medicine and Science. Founded in 1912, the Chicago Medical School has a nearly 100 year history of a broadly-based socially constructive admission process relatively unlike that of other in 1968, performed his surgical residency at Strong Memorial Hospital, and completed his orthopedic surgical residency at Case Western Reserve and University Hospitals. About LDR Spine LDR Spine supplies U.S. surgeons with innovative spinal solutions in partnership with LDR Medical of Troyes, France. LDR Spine works closely with surgeons to develop implantable systems and instrumentation that restore optimum stability and mobility to patients, and make spine surgery more reproducible and easier to perform. More information is located at www.ldrspine.com. |
|
||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion