‘Omnia Medical VBR’ has been granted the first US FDA 510(k) clearance for a vertebral body replacement (VBR) system manufactured from PEEK-OPTIMA HA Enhanced polymer, from Invibio Biomaterial Solutions, for use in the thoracolumbar spine to replace a collapsed, damaged, or unstable vertebral body. This advancement was the result of a three-way collaboration: orthopedic implant company Omnia Medical partnered with JALEX Medical on product development and regulatory activities and with Invibio Biomaterial Solutions, who pioneered medical PEEK.
Robert Gewirtz, MD- Neurosurgeon, Columbus, Ohio, comments on the innovative orthopedic product: “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. I am happy that I was able to partner in this collaboration to help bring the product to market.”
Steve Anderson, Vice President of Marketing at Omnia Medical concludes: “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. This unique material combination is a great option for the VBR application due to the large amount of natural anatomy removed during the procedure. Working with JALEX Medical and Invibio Biomaterial Solutions was an excellent experience – and will hopefully enable surgeons and patients to benefit from the new solutions.”
For more information please visit www.omniamedical.com, www.jalexmedical.com and https://invibio.com
REFERENCES
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 orthopaedic surgeons. Their view and experience 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.
Omnia Medical, LLC. Is a privately held medical device company headquartered in Morgantown, West Virginia. Omnia Medical VBR is the first device to be cleared for Omnia Medical, LLC with more products in the corporate pipeline. Omnia is focused on developing and commercializing innovative spine devices to help address unmet clinical needs for spine care and improve long-term patient outcomes.
About JALEX Medical
JALEX Medical is a privately held medical device development and regulatory consulting organization located in Westlake, Ohio. JALEX provides a one stop shop approach to the device industry looking to partner and/or outsource development activities.
About Invibio Biomaterial Solutions
Invibio, a Victrex plc company, 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, orthopaedic and dental medical segments for the development of long implantable medical devices. Today, Invibio’s PEEK-OPTIMA™ polymers are used in approximately 9 million implanted devices worldwide.
INVIBIO™, PEEK-OPTIMA™, INVIBIO BIOMATERIAL SOLUTIONS™ are trademarks of Victrex plc or its group companies.
All rights reserved. Find out more at https://invibio.com/
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