The US Food and Drug Administration (FDA) has granted ReGelTec an investigational device exemption (IDE) for the company’s HYDRAFIL system.
The device contains a polymer that is injected into a diseased disc and cools to form an integrated solid. This mimics the biomechanical properties of a natural disc.
The hydrogel technology’s safety and effectiveness are being evaluated in a multicentre, single-blinded, randomised, controlled trial (NCT06011551). The study, called HYDRAFIL-D, is estimated to enrol around 225 patients with axial chronic back pain due to degenerative disc disease and who have not responded to conservative care. ReGelTec expects to begin enrolment in early 2024.
After 12 months of the gel’s implantation, ReGelTec will assess function, serious adverse events, surgical site infections, intercurrent events, and radiographic findings to determine clinical success.
The gel implant is delivered percutaneously via a needle under local anaesthesia to the affected lumbar disc.
Degenerative disc disease is considered a normal part of ageing, but its effects on motion can severely affect daily activities. Artificial discs are becoming a gold standard treatment for the condition but require invasive procedures. According to GlobalData’s medical device pipeline, 32 artificial disc replacement systems are in various stages of development. ReGelTec says its product, however, could offer a minimally invasive treatment option.
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Dr Kasra Amirdelfan, director of clinical research at California’s Boomerang Healthcare, and one of two national principal investigators said: “The HYDRAFIL System is designed for a segment of the chronic low back pain population who are not very good candidates for conventional spine surgery.
“When conservative care fails, these patients have limited treatment options. HYDRAFIL appears to be a great option for these patients.”
In June, Synergy Spine Solutions completed enrolment for its IDE clinical trial evaluating its artificial disc in patients with degenerative disc disease.