Omnia Receives First Ever FDA Clearance for PEEK-Optima HA Enhanced Cervical Vertebral Body Replacement

 

U.K.’s Omnia Medical has been granted the first FDA 510(k) clearance for cervical vertebral body replacement (VBR) system—Boxcar VBR—manufactured from PEEK-Optima HA Enhanced polymer from Invibio Biomaterial Solutions (U.S. office in West Conshohoken, Penn.). Sources at Invibio, a compounder of PEEK-Optima polymers for medical devices, confirm that this is the first time HC filler—the main constituent of bone and tooth enamel, has been integrated into a PEEK and the first time it has been used for a spinal implant.

The Boxcar system has been designed for use in cervical-corpectomy procedures--that is, the replacement of a collapsed, damaged, or unstable vertebral body located in the cervical spine. Nerorosurgion Robert Gewirtz, Columbus, Ohio, collaborated on the development of the Boxcar VBR product, and he had this to say about the cervical VBR clearance. “I see many patients that require a cervical corpectomy, and it's exciting to have such an innovative option for these patients. Boxcar is very easy to use and provides intra-operative flexibility, allowing me to dial in a VBR construct to match my patient’s anatomy. Hydroxyapatite is incorporated into the PEEK-Optima structure of the implant, which delivers potentially improved outcomes for my patients”.

The novel single-use device is available in two footprints and allows fine adjustments of height and lordosis using spacers and endplates. It features a hollow center and holes to accommodate autograft or allograft, while encouraging the formation of new bone, and includes anti-migration features.

Said Omnia’s v.p. of marketing Steve Anderson, “There is a limited number of 510(k) FDA cleared cervical VBR products on the market, and for our company to gain the first approval for a PEEK-Optima HA Enhanced cervical corpectomy device is a great achievement. I’m absolutely confident surgeons will see the clinical benefits for them and their patients. Omnia Medical is focused on bringing truly innovative products to market, and Boxcar is the first of many ‘first to market’ products from our company, going forward.”

In PEEK-Oprima HA Enhanced, hydroxyapatite (HA), a well-known osteoconductive material that enhances bone apposition, is fully integrated into the polymer matrix, and not simply coated. Invibio´s enhanced biomaterial offers all the clinical advantages of PEEK-OPTIMA Natural, including a modulus similar to that of cortical bone – unlike the metal or mesh cages in earlier use, plus reduced stress shielding and artifact-free imaging that allows for clear fusion assessment. It has been shown to improve bone apposition compared to unfilled PEEK-Optima Natural in a pre-clinical ovine model at 4 weeks and 12 weeks, and also demonstrated performance advantages in a pre-clinical cervical spine fusion model in sheep at 6 and 12 weeks.² In addition, as observed by surgeons, early clinical results have shown solid fusions with dense bone apposition at 6 months and beneficial clinical outcomes for patients, revealing specific improvements in overall pain and neurological function, when a PEEK-Optima HA Enhanced interbody fusion device was used.