Omnia Medical has announced that the US Food and Drug Administration (FDA) has cleared its new vertebral body replacement (VBR) system, which is manufactured from PEEK-OPTIMA HA Enhanced polymer (Invibio Biomaterial Solutions). The system is designed for use in thoracolumbar procedures where a vertebral body is damaged or unstable. Omnia says that this is the first US clearance for a VBR manufactured from the polymer.
The Omnia Medical VBR, says the medical device company, is available in two footprints and accommodates spacers and endplates for custom height and lordosis adjustments in patients. It also allows for the use of autograft or allograft materials to be used in a fusion procedure.
PEEK-OPTIMA HA Enhanced is a PEEK-based polymer matrix integrated with hydroxyapatite (HA), an osteoconductive material that encourages bone formation and has a similar modulus to cortical bone.
“This unique material combination is a great option for the VBR application due to the large amount of natural anatomy removed during the procedure,” says vice president of Marketing at Omnia Medical, Steve Anderson. “We are happy to be the first to be granted FDA 510(k) clearance for a vertebral body replacement (VBR) system manufactured from PEEK-OPTIMA HA Enhanced biomaterial.”
The company says that PEEK-OPTIMA HA Enhanced “has been shown to improve bone apposition compared to unfilled PEEK-OPTIMA Natural in a pre-clinical ovine model at four weeks and 12 weeks, and also demonstrated performance advantages in a pre-clinical cervical spine fusion model in sheep at six and 12 weeks.”
Early clinical results for PEEK-OPTIMA HA Enhanced, says Invibio Biomaterial Solutions, have “shown solid fusions” and “specific improvements in overall pain and neurological function” at six months.
“Omnia Medical VBR is an intuitive device that is easy for the surgeon to use, and the benefits of hydroxyapatite incorporated into the structure of the implant is a real advance for our patients as it potentially offers improved outcomes,” says Robert Gewirtz, a neurosurgeon based in Columbus, USA.
Anderson adds, “This unique material combination is a great option for the VBR application due to the large amount of natural anatomy removed during the procedure.”
Omnia Medical partnered with Invibio Biomaterial Solutions to produce the Omnia Medical VBR, and with consultants JALEX Medical on product development and regulatory compliance.