Intelligent Implants Ltd., a development-stage, medical device company with offices in Cork, Ireland; Gothenburg, Sweden; and Houston, Texas announces that its SmartFuse system has received Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA).
Intelligent Implants SmartFuse technology is a wirelessly enabled orthopedics platform that has been designed to remotely stimulate, control, and monitor bone growth. The goal of the SmartFuse system is to accelerate bone growth and provide remote monitoring of the patient to support real-time clinical decision-making. The first indication for the SmartFuse system will be for use in lumbar spinal fusions.
FDA Breakthrough Device designation is granted to certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The goal is to give patients and doctors timely access to these medical devices by speeding up their development, assessment, and review, while preserving the statutory standards for premarket approval.
“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,” says John Zellmer, CEO. “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.”
