Beyond the Pitch
Intellirod Spine’s New High-tech Measurement of Spine Healing
These days, wireless technology is increasingly becoming part of the nuts and bolts of innovative design.
From automobiles to oil wells, devices and machines are transmitting data wirelessly—information that measures performance, provides failure alerts, and helps the human users have a better experience.
Now, Intellirod Spine adds to the list with implantable, wireless, monitoring systems designed to measure the progress of spine healing after lumbar surgery.
From inside the body, these sensors send physicians the data they need to achieve potentially better patient outcomes, both during surgery and post-operatively.
Better Data Contributes to Better Outcomes
Each year in the U.S., more than 450,000 lumbar spinal fusions are performed to treat fractures and instability, to correct deformities, or to eliminate pain. In these procedures, the surgeon positions bone grafts around the spine; the goal is for the body to grow new bone to connect (or fuse) the grafts to existing vertebrae.
During surgery, a system of metal rods and screws, typically made of titanium or cobalt chrome, is implanted to stabilize the spine and help it heal.
“Strain on the implanted rods lessens as new bone grows after surgery,” said Ric Navarro, president and CEO of Intellirod Spine. “When the spine doesn’t fuse, there is more strain on the rods.”
Currently, surgeons use radiography and CT scans during recovery and rehab to determine whether the spine is successfully fusing and growing new bone after surgery. Intellirod Spine’s wireless sensors provide mechanical data on the strain on the rods. This information compliments medical assessments from x-ray or CT scans.
“We are undergoing clinical studies to collect data for FDA at the Cleveland Clinic, the OhioHealth Grant Medical Center, and the Norton Leatherman Spine Center in Louisville and seeking a fourth site, said Navarro, who has more than 25 years of medical device and implant experience in artificial heart, operating room equipment, and spinal implants. He has also been inventor on 22 patents and has commercialized numerous spine and operating room products.
What’s Next for Intellirod Spine
Breakthroughs in healthcare often begin with ideas from medical professionals who work with patients every day.
The vision for Intellirod Spine came from orthopedic surgeon and co-founder Rolando Puno, MD. Puno, the inventor of a polyaxial screw that has become the industry standard for most spinal fixation implants, worked with a multi-disciplinary team from the University of Louisville.
Additional applications for the implantable RFID sensor are in the works. “One is the idea of a spinal brace that promotes wearing it with real-time monitoring of the patient at home, giving them reminders and alerts,” Navarro said. “Incorporating electronics in the brace would allow remote real-time monitoring anytime and anywhere.
Such a device could help children diagnosed with scoliosis as well as spine surgery patients.
With the movement to outcomes-based medicine, the healthcare industry is looking for innovative ways to capture the data needed to measure results reliably.
“Our products are all about creating the data to measure outcomes. That is sitting well with the industry in terms of outcome-based approvals,” said Navarro. “We have had a lot of interesting developments in the last year. We had a successful funding raising in June, with investment from OhioHealth, the Queen City Angels, and private investors.”
With considerable intellectual property and both issued and pending patents, Intellirod Spine’s next set of critical milestones involve the U.S. and international regulatory approvals in advance of commercial sales.
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