Intelligent Implants Ltd. has announced FDA breakthrough device designation for its SmartFuse orthopedic implant technology, according to a press release.
The SmartFuse platform is designed to remotely stimulate, control and monitor bone growth for real-time clinical decision-making. The product will be indicated for first-use patients who undergo lumbar spinal fusions, according to the release.
“We are pleased the FDA has granted breakthrough device designation for SmartFuse, a next-generation technology platform for orthopedics. It underscores the urgent need for more effective treatments for patients suffering with degenerative disc disease,” John Zellmer, CEO of Intelligent Implants, said in the release. “We look forward to working closely with the FDA through future clinical trials and review processes for SmartFuse. We expect to benefit from additional FDA input during premarket development, as well during the submission process and through an expedited review once the submission is filed. Our goal is to bring this important new technology to a patient population with a significant unmet medical need,” Zellmer added.
“Breakthrough device designation is a strong confirmation of the disruptive potential of the SmartFuse system,” Benjamin Hertzog, executive chair of Intelligent Implants, said in the release. “I believe that SmartFuse represents the future of medical devices, where we have smart implants designed to not only provide a therapeutic benefit, but to also provide data to support real-time clinical decision-making throughout the duration of therapy. The industry has been talking about this paradigm for a while now, but with SmartFuse, the future is here.”