Medtronic Inc. has announced the launch of the commercial introduction of a new set of surgical instruments used for the treatment of single-level cervical disc disease, one of the most common diagnoses for chronic neck and arm pain.
(Daily News File Photo)
The new ACD Instrument Set, which is touted to be much easier to use than previous instruments, is produced by the company’s Memphis-based Spinal and Biologics business.
More than 17,000 patients are projected to undergo a cervical disc replacement procedure in 2012, according to Medtronic estimates.
“The original instruments required a very large mainframe to be attached to the operating table, and then a large derrick was then affixed to the mainframe,” said Dr. Rick Sasso of the Indiana Spine Group, who explained that a complex array of measurements had to be calculated by the doctors at the back of the operating room to figure how to position the derrick on the mainframe. “The technique worked very well, but the problem was that placement of the elegantly designed Bryan discs was laborious. So the challenge was to make it easier.”
The new ACD instrument set eliminates the need for unwieldy mainframes or derricks as well as the complicated measurements needed to affix the mainframe to operating tables.
“The new instrumentation is very user friendly, very easy, very intuitive,” said Sasso, who was involved with the product’s design and testing.
He explained that the new tool set was actually created years ago and has already been in commercial use in Europe for several years.
U.S. surgeons have been forced to wait for U.S. Food and Drug Administration approval, which happened earlier this year. The first surgery in the U.S. with the new instrument set was completed in Houston in July.
Sasso and other surgeons will now be able to use the same technique that has been used for anterior cervical fusion for more than 50 years with excellent success rates.
The tools are designed for use with Medtronic’s clinically proven Bryan cervical disc, a medical device used in disc replacement surgery that is made of two metal (titanium) shells and a plastic (polyurethane) central core. It is designed to provide motion by allowing movement between the metal components and the plastic component.
Medtronic has sold more than 20,000 Bryan disc implants worldwide since January 2000 when the first surgery was performed in Europe using the original instrument set developed by Seattle neurosurgeon, Dr. Vincent Bryan.
Bryan founded Spinal Dynamics Inc. in 1993 to pursue the development of the device, and Medtronic acquired Spinal Dynamics in 2002.
The disc was FDA approved in 2009 and has been used outside of the U.S. since 2000 in more than 30 countries on six continents. The Bryan disc is one of three FDA-approved cervical disc replacement devices that are currently available in the U.S.
Doug King, president of Medtronic’s Spinal business in Memphis, pointed out that Medtronic is the only company with two clinically proven artificial cervical discs in its portfolio, both with different designs and made of different materials in order to accommodate surgeon preference.
“We are very excited to provide this enhanced instrument set and motion device to physicians seeking to offer their patients an alternative to fusion,” King said in a prepared statement.