Healthcare Industry News: spine surgery
News Release - June 1, 2006
Second Generation Cervical Artificial Disc Kicks Off Multiple U.S. Surgeries in Research Study Launch
LDR's Mobi-C(R) Begins FDA Investigational Study with First 15 Patients EnrolledAUSTIN, Texas--(HSMN NewsFeed)--June 1, 2006--During a controlled launch, the first 15 patients were enrolled in a pioneering cervical artificial disc research study in multiple locations throughout the United States. The Mobi-C cervical disc prosthesis is a second generation, investigational implant designed with innovative mobile bearing technology and a one-step implantation technique. The U.S. IDE study was approved by the FDA this February for both one and two-level implantations.
Arnold Schwartz, MD, and Paul Alongi, MD, of Orthopedic Spine Care at Huntington Hospital in Long Island, NY, were the first in the U.S. to implant a Mobi-C. Dr. Schwartz offers, "The surgery went smoothly and the device and instrumentation were easy to use. The Mobi-C's design intuitively makes sense to a surgeon."
This study is unique in that it is the first, second generation disc approved for an investigational research study for both single and two-level disc surgeries concurrently. Drs. Dan Peterson and John Stokes with Austin Brain and Spine performed the study's first two-level surgery at Brackenridge Hospital in Austin, Texas.
Dr. Peterson said, "Many of our patients have indications such that a two-level surgery is necessary. It is encouraging that we can participate in an investigational study to determine if there are advantages to using the Mobi-C versus a standard two-level fusion procedure."
Dr. Stokes adds, "Many cervical discs currently in IDE studies in the U.S. have center keels requiring cutting a channel into the top and bottom vertebrae in the spine. The Mobi-C design does not require this and therefore can be used in two level patients without the potential concern of fracturing the vertebrae."
The Mobi-C design is intended to provide contained mobility for better replication of anatomical movements, a more natural range of mobility that includes six degrees of freedom, and one-step implantation to potentially simplify the surgical technique. Lateral stops on the inferior plate control and limit the movement of the mobile insert and reduce the potential for insert migration.
Christophe Lavigne, the founder and CEO of LDR concludes by saying, "Outside the U.S., we have implanted the Mobi-C artificial cervical discs in more than 14 countries in the past 18 months. Initial results from the Mobi-C European pilot study were included in the IDE submission to the FDA. We are excited to begin our U.S. IDE study in such a strong way."
About LDR: LDR supplies surgeons worldwide with innovative spinal solutions for fusion and non-fusion needs. The company 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.
The Mobi-C® Cervical Disc Prosthesis is an investigational device and is limited by federal law to investigational use only.
Source: LDR Spine
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