Business Wire04.02.19
Intellirod Spine, the spinal sensor technology company developing wearable, disposable, and implantable wireless sensors for spine surgeons and their patients, obtained FDA De Novo approval for its revolutionary disposable spinal rod strain sensor, the LOADPRO. The device clamps onto a standard 5.5mm rod for use in monitoring rod strain during a kyphotic correction surgery. This initial approval is for use of LOADPRO with the FORTEX pedicle screw system from Xtant Medical.
“We are delighted to be the first device in this new FDA product category for spine to give the surgeon unprecedented new information about how much strain is on their rods as they correct a deformity,” said Ric Navarro, CEO of Intellirod. “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.”
“FDA granting this De Novo is the result of thorough clinical and non-clinical evaluations to better understand how this technology can benefit surgeons and patients,” said Justin Eggleton, Vice President of Spine Regulatory Affairs for MCRA, the clinical research organization and advisory firm that assists Intellirod. “Intellirod Spine’s collaboration with FDA demonstrates the value of including the Agency early in the process to ensure all evaluations are focused on yielding data that speaks to the benefit-risk profile.”
“Post-market studies will add greater understanding of strains induced on the rods, the effect of different surgeon techniques on rod strain, and how reproducible procedures are relative to rod strain,” said Dr. Rolando M. Puno of Louisville, Ky., a co-founder of Intellirod and a spine surgeon at the Leatherman Spine Center. “Ultimately, we want to understand how our loading of the implants during surgery can affect the outcomes. Implant-related complications in long construct kyphotic deformities can be as high as 20 percent. LOADPRO gives us the tool to do these investigations and to learn the implications of our techniques.”
Intellirod plans to do site releases of the product in Cleveland, Ohio, and Louisville, Ky. The company is planning to expand its commercial launch sites and seek future FDA approvals with additional pedicle screw systems.
“We are delighted to be the first device in this new FDA product category for spine to give the surgeon unprecedented new information about how much strain is on their rods as they correct a deformity,” said Ric Navarro, CEO of Intellirod. “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.”
“FDA granting this De Novo is the result of thorough clinical and non-clinical evaluations to better understand how this technology can benefit surgeons and patients,” said Justin Eggleton, Vice President of Spine Regulatory Affairs for MCRA, the clinical research organization and advisory firm that assists Intellirod. “Intellirod Spine’s collaboration with FDA demonstrates the value of including the Agency early in the process to ensure all evaluations are focused on yielding data that speaks to the benefit-risk profile.”
“Post-market studies will add greater understanding of strains induced on the rods, the effect of different surgeon techniques on rod strain, and how reproducible procedures are relative to rod strain,” said Dr. Rolando M. Puno of Louisville, Ky., a co-founder of Intellirod and a spine surgeon at the Leatherman Spine Center. “Ultimately, we want to understand how our loading of the implants during surgery can affect the outcomes. Implant-related complications in long construct kyphotic deformities can be as high as 20 percent. LOADPRO gives us the tool to do these investigations and to learn the implications of our techniques.”
Intellirod plans to do site releases of the product in Cleveland, Ohio, and Louisville, Ky. The company is planning to expand its commercial launch sites and seek future FDA approvals with additional pedicle screw systems.