Disposable spinal rod strain sensor earns De Novo clearance
- A disposable sensor designed to measure how much strain is being placed on a spinal rod implant during surgery to correct kyphosis, an abnormal rounding of the upper back, has received FDA De Novo marketing authorization.
- The first-of-its-kind wireless electronic sensor, developed by Akron, Ohio-based Intellirod Spine, communicates its measurements of rod strain values to an external reader.
- Called the Loadpro, the single-use device clamps onto a standard 5.5-millimeter-diameter titanium or cobalt chrome rod. The strain-sensing device is not implanted and is removed before surgery closure.
Spine surgery typically is reserved for severe cases of kyphosis, when more conservative treatments such as exercise or bracing are not enough to correct the deformity. Instrumentation related complications (IRC) are among the most common complications that occur in spine surgery.
Over the past two decades, the reported incidence of IRC has ranged from 0.6% to 3% in adolescents with scoliosis and up to 40.2% in adult spinal deformity patients, according to a study published last month in the Journal of Spine Surgery. The study of spinal patients in the Scoliosis Research Society database found that the highest risk of IRC occurred in those with a preoperative diagnosis of kyphosis, and nearly half of those complications were due to the potentially avoidable malpositioning of implants.
Intellirod said implant-related complications in long construct kyphotic deformities can be as high as 20%.
"Now the surgeon can quantify their tactile feel and be knowledgeable of the strain level as it relates to the yield limits of the rod material," Ric Navarro, CEO of Intellirod, said in a press release.
Rolando Puno, a co-founder of Intellirod and spine surgeon at the Leatherman Spine Center in Louisville, said post-market studies of the device will improve understanding of the strains on rods, the effect of different surgeon techniques on rod strain, and the reproducibility of procedures relative to rod strain.
Intellirod's rod strain sensor received initial approval for use with the Fortex pedicle screw system from Xtant Medical. The company said it will seek FDA approval for use of the device with additional pedicle screw systems.
The Loadpro will be released initially at sites in Cleveland and Louisville, Kentucky, with plans to expand the commercial launch to more sites eventually.
- Intellirod Intellirod Spine Receives First-Ever Spine FDA De Novo Approval
- FDA FDA Letter to Intellirod
- Journal of Spine Surgery Instrumentation complication rates following spine surgery: a report from the Scoliosis Research Society (SRS) morbidity and mortality database
- Intellirod Spine LOADPRO™ Intraoperative Rod Strain Sensor
- ClinicalTrials.gov Intra-operative Assessment of the Intellirod LOADPRO Spinal Rod Strain Sensor for Use During Kyphotic Corrective Surgery (LOADPRO)