Invibio Offers Trauma Technology Platform in PEEK

A new offering from Invibio Biomaterial Solutions showcased during the annual meeting of the American Academy of Orthopaedic Surgeons (AAOS, March 24-28) in Las Vegas, Nev., delivers trauma plates composed of the company’s PEEK-Optima Ultra Reinforced material.

Clear regulatory device predicates in the United States and Europe enable medical device manufacturers to more easily expand their trauma range beyond metal technologies, according to officials for United Kingdom-based Invibio. The polymer-based anatomic devices could be appropriate in those cases, where the prognosis is poor, particularly with high-risk patients.

According to the company, PEEK-Optima Ultra Reinforced improves the visibility of the fracture during surgery, improving the ability to assess reduction and alignment. Initial results from an ongoing survey indicate that more than 80 percent of surgeons can identify poor fracture alignment when PEEK-Optima Ultra Reinforced is used as opposed to less than 30 percent for metals.¹ The survey is focused on the assessment of two fracture fixation areas, the proximal humerus and the distal femur.

Unsuccessful treatment of fractures, resulting in non-unions, costs the healthcare system more than $2 billion in the United States.² In the literature, non-union rates have been detailed as high as 19 percent for distal femoral plating.³ While metallic implants have been used for the last century with limited changes, the patient population has become more challenging with increasing co-morbidities such as obesity, diabetes and osteoporosis. This, combined with a longer life expectancy and a desire to maintain a quality of life, has driven the need for alternative biomaterials for use in treatments.

PEEK-Optima Ultra Reinforced combines the high-performance material properties of PEEK-Optima Natural polymers with the additional strength imparted by continuous carbon fiber. The material can be tailored to have mechanical strength similar to that of metallic plates, combined with a 50-times greater resistance to fatigue, extending implant lifetime.^4,5 Hardware removal complications are likely to be reduced as carbon fiber PEEK composites are biologically inert, having low tissue adhesion and cold welding of screws does not occur.⁶


References
1. Data on file at Invibio.
2. HCUP Nationwide Inpatient Sample (NIS), 2012, Agency for Healthcare Research and Quality (AHRQ) Assumes non-union rate of 10%
3. CE Henderson, LL Kuhl, DC Fitzpatrick, JL Marsh, Locking Plates for Distal Femur Fractures: Is There a Problem With Fracture Healing?, J Orthop Trauma, 2011, Vol 25, S8-S14
4. Data on file at Invibio. Pre-clinical and biomechanical testing is not indicative of clinical performance.
5. Data on file at Invibio. Biomechanical testing is not indicative of clinical performance.
6. L Tarallo, R Mugnai, R Adani, F Zambianchi, F Catani, A New Volar Plate made of Carbon-Fiber-Reinforced Polyetheretherketon for Distal Radius Fracture: Analysis of 40 Cases, J Orthop Trauma, 2014, Vol 15, 277-83