Transforming trauma with polymer composites

Breakthrough implantable PEEK-OPTIMA™ polymers for fracture fixation

Trauma

Megatrends

Setting the standard for over 20 years

More than twenty years ago, the biocompatible PEEK-OPTIMA^TM Natural polymer quickly became the material of choice in interbody fusion and developed a successful clinical track record.
Today, approximately 15 million PEEK-OPTIMA^TM devices are implanted worldwide.

Challenging patient health risk factors

Increasing global rises in high risk conditions that reduce the ability to heal after a fracture. Studies show that there is an elevated non-union risk associated with severe fractures in people with a high body mass index, and a history of smoking, and alcoholism.⁵

The rising cost of complications

Adverse events are 3 times more likely in trauma patients than other orthopedic patients, which is leading to more frequent and higher costs to revise and deal with complications.⁶

Reducing risk through device design

Medical device companies are seeking a new generation of high performance fixation devices that can offer adequate fatigue strength to withstand loads through the healing process, especially in patients with risk factors for implant related complications.

Applications

TRAUMA APPLICATIONS

Our biocompatible carbon fiber composite material, PEEK-OPTIMA Ultra-Reinforced polymer, offers an alternative to metal for fracture fixation devices for high-load implant applications

Patient-specific craniomaxillofacial implants

PEEK-OPTIMA high performance polymer is a strong, permanent, functional alternative to traditional structural materials like metal that can be used to manufacture custom cranial implants. PEEK-OPTIMA’s biomechanical properties are similar to bone, result in better clinical outcomes and have improved cosmetic satisfaction compared to titanium.

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Sternal closure

Cerclage wires have been the standard of care for sternotomies but can result in loosening and patient discomfort when coughing. Poor bone quality in geriatric patients can also result in wire cut through and instability post operatively. Studies have shown rigid fixation results in better outcomes compared to standard cerclage wires. PEEK-OPTIMA polymers have been used to innovate in this space, with OEMs developing new metal-free technologies for fixation plate, ties and zips.

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Resources

Evidence in Trauma solutions

Video

Introduction to Invibio's trauma solutions from leading KOLs

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infographic

Distal femur outcomes in high risk patients

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Olympic Athelete James Ellington running with his carbon fiber PEEK implant

OLYMPIC ATHELETE fracture fixation

British Olympic sprinter James Ellington, the first professional athlete to have a trauma composite technology implant.

Read about his journey

PEEK-OPTIMA™ Ultra-Reinforced Polymer Brochure

Material information

Learn about PEEK-OPTIMA Ultra-Reinforced polymer technology, pre-clinical test results and clinical history

Download information for device manufacturers

Materials

MEDICAL-GRADE MATERIALS

PEEK-OPTIMA™ polymer blends for proven performance with superior wear, safety and comfort. Since Invibio introduced PEEK-OPTIMA as the first implantable PEEK polymer in 1999, it has earned the confidence and gained the acceptance of the global medical community.

Natural
HA Enhanced
Image Contrast
Reinforced
Ultra-Reinforced

More than twenty years ago, the biocompatible PEEK-OPTIMA^TM Natural polymer quickly became the material of choice in interbody fusion and developed a successful clinical track record. Today, approximately 15 million PEEK-OPTIMA polymer devices are implanted worldwide. This high-performance, implant-grade polymer serves as the foundation for the PEEK-OPTIMA product family.

Natural
HA Enhanced
Image Contrast
Reinforced
Ultra-Reinforced

All the benefits of PEEK-OPTIMA^TM Natural plus Hydroxyapatite (HA) crystals embedded throughout the material, a well-known osteo-conductive material. Unlike interbody fusion devices that are coated, PEEK-OPTIMA^TM HA Enhanced devices have hydroxyapatite crystals on all surfaces which results in earlier bone on-growth and greater new bone formation on a fully osteoconductive implant. Key benefits include:

Enhanced bone apposition^1,
Greater new bone formation²
Higher quality of new bone bridging^2.

Natural
HA Enhanced
Image Contrast
Reinforced
Ultra-Reinforced

PEEK-OPTIMA^TM Image Contrast offers all the performance advantages of the clinically proven and highly utilized PEEK-OPTIMA^TM Natural, with one unique difference: it allows for tailored radiolucency that can be optimized for application-specific image guidance and post-operative healing assessment requirements.

Natural
HA Enhanced
Image Contrast
Reinforced
Ultra-Reinforced

A carbon fiber reinforced PEEK polymer compound to increase strength while reducing stress shielding by more closely matching cortical bone stiffness. Short carbon fibers are dispersed within the PEEK-OPTIMA^TM Natural matrix enhancing mechanical and physical properties for more demanding load-bearing implants and applications. Benefits include³:

Fiber-to-matrix bond strength provides higher strength than PEEK-OPTIMA Natural Polymers
Bone-like stiffness can reduce stress shielding by more closely matching cortical bone stiffness
Extensive history of use in FDA 510(k) cleared, long-term implantable devices

Natural
HA Enhanced
Image Contrast
Reinforced
Ultra-Reinforced

An innovative composite formed by continuous carbon fibers dispersed within the PEEK-OPTIMA Natural polymer matrix to enhance mechanical strength and stiffness.

Benefits include:

Excellent fatigue resistance and structural strength for device longevity⁴
Tailored stiffness for design flexibility⁴
Radiolucent, offering circumferential visibility of the surgical site before and after the procedure.

References for PEEK-OPTIMA^TM materials

1. Study evaluated the bone ongrowth of PEEK-OPTIMA Natural and PEEK-OPTIMA HA Enhanced in a bone defect model in sheep. Data on file at Invibio. This has not been correlated with human clinical data.
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 data has not been correlated with human clinical experience.
3. Supporting information available upon request.
4. Data on file at Invibio Biomaterial Solutions™. Mechanical Benchmark of Carbon Fiber PEEK-OPTIMA™ Ultra-Reinforced vs Ti 6AI-4V Plates undergoing Static and Dynamic Testing per ASTM F382-99 (2008).

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References

1.Data on file at Invibio Biomaterial Solutions. Mechanical Benchmark of Carbon Fiber PEEK-OPTIMA™ Ultra-Reinforced vs Ti 6Al-4V Plates undergoing Static and Dynamic Testing per ASTM F382-99 (2008).
2.Ziran BH, Mansour J, Jahangir AA, Min W. Efficacy of Carbon Fiber-Reinforced PEEK Femoral Nail Preliminary Results. Poster #68. Presented at OTA 2017.
3.Allison DC, Menendez LR. Carbon fiber fixation in oncologic bone surgery. Presented at MSTS Meeting 2013. Carbon Fiber Intramedullary Nail Fixation in Troublesome Long Bone Fractures and Nonunions in Cedars-Sinai Advances in Orthopaedics Newsletter, Spring 2014.
4.Zimel MN, Hwang S, Riedel ER Healy JH. Carbon fiber intramedullary nails reduce artifact in postoperative advanced imaging. Skeletal Radiol. 2015 Sep;44(9):1317-25.
5.Zura R, Xiong Z, Einhorn T, Watson JT, Ostrum RF, Prayson MJ, Della Rocca GJ, Mehta S, McKinley T, Wang Z, Steen RG. Epidemiology of Fracture Nonunion in 18 Human Bones. JAMA Surg. 2016 Nov 16;151(11):e162775. doi: 10.1001/jamasurg.2016.2775. Epub 2016 Nov 16. PMID: 27603155.
6.Sathiyakumar V, Thakore RV, Greenberg SE, Whiting PS, Molina CS, Obremskey WT, Sethi MK. Adverse Events in Orthopaedics: Is Trauma More Risky? An Analysis of the NSQIP Data. J Orthop Trauma. 2015 Jul;29(7):337-41. doi: 10.1097/BOT.0000000000000293. PMID: 26091531.