Please can you give a brief introduction to cervical disc replacement?
Cervical disc replacement is a surgical procedure that involves removing a damaged or degenerated cervical disc and replacing it with an artificial disc device.
Cervical discs are the cushions or shock absorbers between the bones (vertebra) of the neck (cervical spine). Discs that become damaged either through trauma or degeneration can be a source of pain. If part of a disc moves out of its normal position it can cause pressure on the central spinal cord or on the individual nerve roots that exit from the spinal canal at each vertebral level.
Disc degeneration can be a source of neck pain as well as cause neurologic symptoms which may include pain, numbness or weakness that radiates from the neck into one or both arms.
Until recently, the standard treatment would be a spinal fusion, where implants are used to connect the two vertebrae above and below the damaged disc rigidly. The outcomes of this procedure can be very good, however a spinal fusion eliminates motion at the operative spinal levels and it has been theorized that this loss of motion may accelerate the degenerative process at other levels of the spine.
In contrast, cervical disc replacement maintains motion at the operative level and may help to improve long-term clinical outcomes.
What are the differences between one and two level applications?
The level refers to the number of cervical discs involved in the procedure. A one-level procedure involves one cervical disc while a two-level procedure involves two discs.
In our study the U.S. Food and Drug Administration (FDA) is evaluating submissions for our Mobi-C artificial cervical disc for both one and two-level indications.
How many people suffer from the two-level pathology?
The estimates from analysts and leading physicians point to roughly 250,000–275,000 anterior surgical procedures performed in the United States annually.
In terms of the percentage of those patients who may be appropriate for cervical disc replacement, it may be between 25 to 40 percent of those patients long-term.
Why is there currently no available cervical disc treatment for two-level cervical disease?
Currently, no artificial cervical discs have full FDA approval for two-level indication. The currently available on-label procedure for two-level treatment is anterior cervical discectomy and fusion.
Please can you outline LDR’s Mobi-C® Cervical Disc?
The Mobi-C is a three-piece cobalt chromium alloy and polyethylene artificial cervical disc with a unique mobile bearing core. Whereas most cervical discs use keels or screws for fixation, Mobi-C’s mobile core is designed to help minimize stresses between the implant and the bone thereby eliminating the need for the more invasive fixation features found in other devices.
In addition, the controlled motion provided by the mobile core has proved suitable for not only one-level, but two-level cervical arthroplasty as well. In fact, upon pending FDA approval, Mobi-C may be the only device to have demonstrated safety and efficacy for two-level cervical disc replacement.
How was Mobi-C® developed?
It was developed 10 years ago by a team of expert physicians, engineers and the LDR founders, and has been used by surgeons outside of the U.S. since 2004.
At what stage of development is Mobi-C® Cervical Disc currently?
LDR announced this month that the FDA granted Mobi-C an Approvable Letter for the two-level submission after an intensive review of the prospective concurrent IDE Clinical Trial for one and two-level cervical disc replacement.
What impact do you think Mobi-C® will have?
Mobi-C has the potential to be the first artificial cervical disc on the market with FDA approval for two-level application, which makes up a significant portion of the patient population with degenerative disc disease.
As such, it has the potential to be a great option for surgeons to use to treat patients while maintaining cervical motion, especially in cases where today the only on-label treatment is multi-level cervical fusion. And very importantly, Mobi-C will bring with it the rigorous clinical evidence to support precise patient selection and informed surgical treatment options.
What plans do LDR have for the future?
LDR's goal is to continue to innovate and to offer surgeons exclusive technology that will help them to provide their patients with the best possible care. We are excited about the potential full FDA approval of Mobi-C in 2013, and we are focused on supporting that launch, as well as continuing support for our entire suite of current and future products.
Where can readers find more information?
www.ldrmedical.com
About Joe Ross
Joe Ross joined LDR in 2010, bringing with him more than 15 years of experience in spine medical devices. His previous position was as Vice President of Strategic Initiatives for Axial Biotech, a developer of novel molecular diagnostic assays for spinal disorders. Earlier, Mr. Ross spent more than eleven years at the DePuy Spine division of Johnson & Johnson in roles of increasing responsibility including Worldwide Vice President of New Business Development.
He has extensive experience partnering with physician and industry leaders to advance innovative clinical solutions. He has led numerous successful product and business development efforts and has been granted multiple U.S. patents. He holds a BBA in Marketing from the University of Notre Dame, an MS in Management from Troy State University and served proudly for five years as an officer in the United States Navy.
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