Omnia Medical Receives First Ever 510(k) Clearance for PEEK-OPTIMA™ HA Enhanced Cervical VBR
US FDA 510(k) clearance paves the way for an innovative orthopedic product that offers the potential to improve bone apposition and, as a consequence, patient outcomes 1-3
Thornton Cleveleys (UK), Sep 24, 2019 – Omnia Medical’s ‘Boxcar’ has been granted the first US FDA 510(k) clearance for a cervical vertebral body replacement (VBR) system manufactured from PEEK-OPTIMA HA Enhanced polymer, from Invibio Biomaterial Solutions. 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.
Robert Gewirtz, MD- Neurosurgeon, 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.
Steve Anderson, Vice President of Marketing at Omnia Medical, adds: “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-OPTIMA 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,1 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,3 when a PEEK-OPTIMA HA Enhanced interbody fusion device was used.
1. Study evaluated the in vivo response to PEEK-OPTIMA Natural and PEEK-OPTIMA HA Enhanced in a large animal model. Data on file at Invibio. This has not been correlated with human clinical experience.
2. Study evaluated the in vivo response to PEEK-OPTIMA™ Natural, PEEK-OPTIMA™ HA Enhanced and allograft in a cervical spine fusion model in sheep. Data on file at Invibio. This has not been correlated with human clinical experience.
3. Testimonials presented have been provided by participating orthopedic surgeons. Their views and experiences are their own and do not necessarily reflect those of others. “Invibio” disclaims any liabilities or loss in connection with the information herein.
About Omnia Medical, LLC.
Top engineers and industry professionals have come together to form Omnia Medical, an orthopedic implant company located in Morgantown, WV. Omnia Medical's mission is to develop novel products that reduce operative time through safe and reproducible instrumentation, while achieving superior surgical outcomes. Ongoing surgeon collaboration helps the company achieve this mission, which ultimately leads to critical cost savings for hospital partners and ultimately the patients.
About Invibio Biomaterial Solutions
Invibio, part of the Victrex plc group of companies, is a global leader in providing high-performance biomaterial solutions to medical device manufacturers. The company provides PEEK-OPTIMA™ polymers, advanced technical research and support and manufacturing of components for spine, trauma and orthopaedic and dental medical segments for the development of long-term implantable medical devices. Today, Invibio’s PEEK-OPTIMA™ polymers are used in approximately 9 million implanted devices worldwide.
INVIBIO™, PEEK-OPTIMA™, JUVORA™, INVIBIO BIOMATERIAL SOLUTIONS™ are trademarks of Victrex plc or its group companies. All rights reserved. Find out more at www.invibio.com
About Victrex plc
Victrex is an innovative world leader in high performance PAEK/PEEK polymer solutions, focussed on the strategic markets of automotive, aerospace, energy (including manufacturing & engineering), electronics and medical. Every day, millions of people use products and applications, which contain our materials – from smart phones, aeroplanes and cars to oil and gas operations and medical devices. With 40 years’ experience, we develop world leading solutions in PEEK and PAEK-based polymers and selected semi-finished and finished parts which shape future performance for our customers and our markets, and drive value for our shareholders. Find out more at www.victrex.com
From the invention of PEEK over 40 years ago, Victrex has continually pioneered new PAEK-based polymers, materials and solutions that have transformed markets, delivering global impact in the toughest environments.
We bring transformational & sustainable solutions that address world material challenges every day.