Theradaptive has announced that the US Food and Drug Administration (FDA) has granted breakthrough medical device designation to its Osteo-Adapt SP Spinal Fusion implant indicated for transforaminal lumbar interbody spinal fusion to treat degenerative disc disease, spondylolisthesis, or retrolisthesis.
Under the Breakthrough Devices Program, the FDA will provide Theradaptive with priority review and interactive communication regarding device development and clinical trial protocols during the premarket review process.
“Theradaptive has developed a technology that may provide several significant advantages over the current state-of-the-art in spinal fusion and musculoskeletal repair, including greater safety and more consistent outcomes,” said George Muschler, an orthopaedic surgeon at the Cleveland Clinic (Cleveland, USA). “This is an exciting development in the field and having a breakthrough designation from the FDA is strong validation of the approach. The potential for patients is enormous.”
Theradaptive’s regenerative implants are designed to permit precise tissue regeneration for a variety of tissue types and clinical indications. According to the company, the new technology enables superior outcomes and safety, and greatly improved ease of use.
John Greenbaum, senior vice president of clinical and regulatory operations at Theradaptive, added: “This designation is a major milestone for Theradaptive as we aspire to change the practice of medicine by enabling precise tissue regeneration in a way that was not previously possible. This opens the door to entirely new treatments for conditions that currently have very few options.”