Scient'x (Maitland, Florida), a private manufacturer of spinal implant technologies, reported receiving FDA 510(k) clearance to market its Isobar Duo Dynamic Stabilization System. The device is an extension of its original Isobar Dynamic TTL-Rod, which was cleared by FDA in 1998, the company said.
Scient'x said the Isobar Duo has been cleared to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment; fracture, dislocation, scoliosis, kyphosis, spinal tumor; and failed previous fusion.
"What's really exciting [about the Isobar Duo] is it expands out to multiple levels, it's not just limited to a single level," said John Sanders, manager of quality and regulatory affairs at Scient'x.
It still is cleared only as an adjunct to fusion, Sanders said, "but it is an exciting step in the evolution of this product."
Speaking from the Spine Arthroplasty Society (Aurora, Illinois) annual meeting in Miami Beach, Sanders told Medical Device Daily that the company developed Isobar Duo in response to surgeon requests to use the Isobar Dynamic TTL-Rod technology at multiple levels.
"We've had multiple requests where docs want to not just be limited to a single level, they want to be able to use it at multiple levels," Sanders said.
With the Isobar Duo, the surgeon is able to use a standard 5.5 mm diameter rod with two dampener elements that provides controlled motion for use at two levels, Scient'x said.
Last month Scient'x reported that it had repurchased the Isobar dynamic rod license from Alphatex Spine (Carlsbad, California), thus, it said, making it the "exclusive holder" of the Isobar dynamic rod intellectual property globally. Alphatec said it was making the sale because it felt the product did not fit in with its current marketing strategy (Medical Device Daily, April 25, 2008).
"The FDA 510(k) clearance of the Isobar Duo system combined with the repurchase of the license agreement on the Isobar Dynamic TTL-Rod from Alphatec will allow Scient'x to strengthen its leading position in the dynamic stabilization spinal implant market," Michael Huggins, CEO of Scient'x, said in a company statement.
Alphatec had originally planned to acquire Scient'x in 2006 (MDD, Sept. 29, 2006). In January 2007, it cancelled that arrangement for undisclosed reasons, and instead signed three license agreements with Scient'x to make and sell several spinal implants in the U.S. (MDD, Jan. 25, 2007).