Intellirod Spine Receives First-Ever Spine FDA De Novo Approval (press release)
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”Tweet this
“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,” says Mr. 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,” says Mr. 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,” says Dr. Rolando M. Puno of Louisville, Kentucky, 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%. 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, Kentucky. The company is planning to expand its commercial launch sites and seek future FDA approvals with additional pedicle screw systems.
About Intellirod Spine
Intellirod Spine™ (formerly OrthoData Inc.) was founded by renowned spine surgeon Rolando M. Puno, M.D. and professors from the University of Louisville. The company is developing multiple wearable, disposable and implantable wireless sensors for improving outcomes and lowering costs. This innovative strain monitoring system will allow spine surgeons to objectively assess intra-operative rod strain. www.intellirodspine.com
About MCRA, LLC
Founded in 2004, MCRA is a leading clinical research organization and advisory firm. MCRA’s value lies in its industry experience and integration of five business value creators: regulatory, reimbursement, clinical research, healthcare compliance and quality assurance. MCRA’s integrated approach of these key value-creating initiatives provides unparalleled expertise for its clients. MCRA has offices in Washington, D.C., Manchester, Conn., and New York, N.Y., and serves nearly 500 clients globally. MCRA has a demonstrated history of driving success in all areas of the medical device industry including spine, orthopedics, cardiovascular, diagnostic imaging, ophthalmics, drug delivery, wound care, dental, general surgery, neurology, in vitro diagnostic (IVD) devices, combination products and biologics. www.mcra.com