VertiFlex, a US-based developer of minimally invasive spinal solutions, has treated the first patient using its Totalis Direct Decompression system, designed for the treatment of lumbar stenosis.
Under the minimally invasive procedure, which was performed at US-based Napa Surgery Centre, a small single midline incision and sequential dilation is made to a working cannula.
Using the company’s proprietary interspinous access technology, the system performs minimally invasive direct decompressions of the lumbar spine.
The FDA-cleared system, which includes both reusable and disposable instruments, can be used to remove the ligament, bone and facet capsule material tissues.
Napa Surgery Center founder and first procedure surgeon Dr Eric Grigsby said the challenge in treating spinal stenosis is removing the ligament without destabilisng the spine.
"The Totalis system allows a more thorough resection of the offending ligament than other minimally invasive options, and still leaves the structural elements of the lumbar spine intact," Grigsby said.
"It’s a very significant advancement in the treatment of spinal stenosis, and the evolution of minimally invasive spinal surgery overall."
VertiFlex president and chief executive officer Earl Fender said; "The procedure offers the best of both worlds in that it enables spine clinicians the ability to safely perform broad lumbar decompressions in a minimally invasive approach."
Earlier in 2011, VertiFlex completed patient enrolment in its pivotal IDE clinical trial of the Superion Interspinous Spacer (ISS).