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A Orthopedic Sensor To Report Progress of Spinal Fusion Aims to Reduce Use of CT Scans


Posted in Orthopedics by Arundhati Parmar on May 12, 2013

The two important features of any new medical device these days is whether it is better for the patient and whether it can take costs out of the system.

Ric Navarro, CEO of Akron, Ohio-based OrthoData, believes he has just that in a novel sensor the company is developing. Called the IntelliRod system, it is an implanted sensor that clamps on to a spinal fusion implant and tells surgeons the progress of the fusion over time by measuring the load on the rod. It is meant to be an alternative to expensive CT scans that are recommended for patients who complain of continuting pain following surgery so that doctors can get a fuller understanding of the condition of the fusion. 

Navarro said the both X-Rays, which is a cheaper mechanism to show bone growth by looking for calcium deposits, and CT scans, a more detailed and more expensive imaging system to do the same thing, leave room for error. CT scans also expose patients to very nigh doses of radiation.

"While a clearer image, the CT scan doesn't tell the physician anything quantitative about the strength about the fusion taking place," Navarro explained in a recent interview. "So an interpretation of what he sees as calcium deposits forming from new bone is required."

And that is where OrthoData's IntelliRod comes in. Instead of looking for images of calcium deposits, which are subjective and open to interpretation, it looks for load data on the fusion rod. 

In sheep studies, the technology has been shown to give a sense of the progress of the fusion four to eight weeks before imaging techniques and it is precisley because it doesn't rely on calcium deposits to report whether spinal fusion is occurring.

"In the formation of new bone, the last thing to occur in that cascade of events is the calcium deposition," Navarro said. "The calcium is a lagging indicator of fusion and it shows up last." The IntelliRod system would provide quantitative data to add to the image data of the X-ray to determine what trend you are on or what course you are on. The load stays high in the rod for patients who are not fusing well and for those that are you are looking for a drop in the load.""

So how does the sensor work? The sensor is clamped on to the spinal fusion rod by the surgeon at the very end of the spinal fusion procedure. Then, during follow up office visits, the sensor reports the load data on the rod to a RFID reader that OrthoData is developing. 

Navarro expects the OrthoData sensor to be a denovo 510(k) device instead of a PMA, which means that the device would meet a moderate risk guidance of the FDA but not have a predicate product. Here's how de described his rationale for the regulatory pathway.

It clamps on to a pedicle screw system but it doesn't change the thereaputic course of the screw system at all. Just monitors and provides data. In that sense, we are a non therapeutic device. we are a diagnostic product and in the sense that we have no battery on this device. The RFID reader provides power through a transcutaneous inductive coupling link that is powered only during the office visit for 30 seconds to up to two minutes. So the FDA can look at this and say there is no power source implanted in the patient, it is used intermittently in terms of giving power to the device and it doesn't change the therapeutic effect of the pedicle screw system.

Navarro has recently raised $1.1 million and hopes to close out between $1.4 million to $1.6 million by the end of the summer. In the next eight to nine months the company will update the product by making it smaller and hermeticaly sealing it. Another sheep study is planned after that. In the second half of 2014, more money will need to be raised to begin human trials.

"Sensors will revolutionize the way we take care of ourselves," Navarro said. "[In our case] a surgeon would know that a fusion was occurring four to eight weeks sooner than he can tell by imaging and that has tremendous value in getting people back to work sooner."

Sensors in orthopedics will be a topic of discussion both at OrthoTec 2013 in Warsaw, Indiana, on June 6 and at MD&M East, in Philadelphia, June 18, two conferences hosted by the publisher of MD+DI.

-- By Arundhati Parmar, Senior Editor, MD+DI 

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