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  • An innovative implant company has just received a big boost from the U.S. Food and Drug Administration and a large infusion of cash from investors, but patients who require fusion surgery in the future are the ones who may see the greatest benefit. 

     

    Fusion surgery is a solution offered to patients suffering from a range of spine problems. Patients with degenerative disc disease for whom conservative treatments have failed may be offered lumbar fusion, and the same is true for patients with the age-related narrowing of the spinal cord known as spinal stenosis. The surgery can offer significant improvement, with recovery often requiring pain medication for relief from discomfort and several months for vertebrae and bone grafts to successfully fuse together. The company Intelligent Implants hopes to make a big difference in how that recovery progresses.

     

    The company has created a smart implant for use in spinal fusion surgery. The wireless devices are designed to be placed between patients’ vertebrae in the same way that is currently done with non-active implants, using the exact same procedure. However, once implanted they behave entirely differently. They both stimulate and steer bone growth and monitor it so that physicians are able to see exactly how much bone growth has occurred.

     

    The intelligent implants are similar in theory to pacemakers, but the fact that they are wireless changes everything. They operate by creating an electric field that is powered externally through a surgical corset worn after the surgery. Much like Apple watches and smart phones use wireless charging pads, the corset powers and guides the implant’s sensors, which can be modulated to aid bone growth and control it. Sensors within the device are able to detect signature changes in graft material so that bone growth can be measured.

     

    The product is known as SmartFuse, and the company’s founders explain that they created the device after a family member had a poor outcome from fusion surgery. They worked to create a solution that would align with current standard-of-care practices from spine surgeons and have already completed large-animal trials on sheep, with results showing three times more bone growth and time to fusion cut by half. In response to their data the U.S. Food and Drug Administration granted it Breakthrough Device designation, which means that the agency believes “the device provides for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions.”  Following the designation, the company has raised $8.7 million in funding, and plans to conduct its first human clinical trials in 2023.  They estimate that they are more than halfway to bringing the product to market. 

     

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