Healthcare Industry News: spine surgery
News Release - November 7, 2006
LDR Medical Reaches Milestone of Over 3,000 Artificial Discs Worldwide
Implantations Driven By 1,250 Second-Generation Cervical Discs ImplantedAUSTIN, Texas--(HSMN NewsFeed)--LDR Medical, a company of LDR Holdings (LDR) and an innovator in non-fusion and fusion spinal implants, has now implanted over 3,000 of its artificial cervical and lumbar discs worldwide. The company has a second-generation technology platform for its artificial discs featuring an innovative mobile bearing design. The number of artificial discs implanted is being driven by a strong and growing acceptance of the Mobi-C® cervical artificial disc.
The Mobi-C has no screws or keels and offers many potential advantages to the surgeon and patient with its unique design. The device was first introduced in November 2004 and began its FDA-approved investigational device exemption study in the United States this spring. The study is the only one that offers both one- and two-level implantation of a cervical disc. Many market analysts believe patient demand will drive the multi-level market and the Mobi-C enrollment seems to validate this forecast.
Christophe Lavigne, CEO of LDR, said, "We are gratified by the strong performance of the Mobi-C worldwide. LDR has surgeons in over 26 countries that regularly use our products - they are particularly excited about the Mobi-C. We now have clinical results with two-year follow-up in approximately 100 of our first European Mobi-C patients. Our clinician team is analyzing and formatting the results which are termed as impressive."
Lavigne comments further, "Additionally, we are pleased with the progress of our U.S. FDA study to prove the safety and effectiveness of the device. This is an important step for our company and our strong IDE clinician team has told us the multi-level market is important to them and their patients. We want to offer solutions beyond cervical plating which we, and others, believe will begin to become less popular - the Mobi-C could be an option instead of cervical plates for one or two levels."
Charley Gordon, a prominent neurosurgeon with Texas Spine and Joint Hospital in Tyler, Texas, comments, "The Mobi-C is an exciting second-generation disc and I am proud to be involved in the study. There are many disc designs being tested and the Mobi-C is unique in that there are no keels or screws involved. The product goes in much like a cervical cage so the technique is familiar to surgeons. I also appreciate the option of using this product for two-level applications and believe this part of the FDA study is an important advantage to my patients."
LDR was founded in 2000 by seasoned spine executives after their successful experience in the design and market introduction of the industry's first iteration of artificial discs. LDR was created to bring innovative non-fusion and fusion spine implants that address unmet or underserved needs to market. The company's flagship product is Mobi-C, a true second-generation cervical artificial disc. Mobi-C was first introduced in late 2004 and subsequently implanted in over 1,250 patients outside the United States. The company has recently focused on gaining approval for Mobi-C in the U.S. via an FDA-approved Investigational Device Exemption (IDE) study for both single- and two-level implantations of the device.
LDR works closely with surgeons to develop implantable spine systems and instrumentation that restore optimum stability and mobility to patients and to make spine surgery more reproducible and easier to perform. More information is located at www.ldrspine.com.
Caution: The Mobi-C® Cervical Disc Prosthesis is an investigational device and is limited by federal law to investigational use only.
Source: LDR Medical
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