ADVANCING THE
SCIENCE OF FUSION

The potential to improve clinical outcomes in orthopedics with PEEK-OPTIMA™ polymers

A leading choice for spinal fusion & orthopedic devices

Setting the standard for over 20 years

Ageing global population


People are living longer and have a strong desire to maintain their quality of life in their later years.

Joint replacement & pain management


Extended life expectancy results in an increasing need to replace worn out body parts or to alleviate pain in order to resume normal activities. 
 

High performance solutions providing societal benefits


Invibio provides solutions that can be used in a minimally invasive manner, helping to enhance clinical benefits.

PEEK-OPTIMA™ HA ENHANCED

Christof Hofstetter, MD and Sigurd Berven, MD discuss advances in materials and present clinical evidence

APPLICATIONS

Spinal interbody fusion

Spine

With over twenty years of clinical history, PEEK-OPTIMATM Natural polymer is the first medical-grade PEEK used in spinal fusion surgeries. PEEK is currently the most widely used biomaterial for interbody fusion, accounting for 50% of all devices used1. Clinical studies suggest that PEEK-OPTIMA performs as well as, or better than, interbody fusion devices made of metals or bone, while providing some distinct clinical advantages over competing biomaterials.

Knee arthroplasty

Hip & Knee

In collaboration with leading scientists and research institutions, our biomaterials for orthopedic solutions are proven to deliver improved biomechanics, reduced wear and enhanced bone growth. Innovative orthopedic device companies have chosen our biomaterial solutions for decades.

Shoulder arthroscopy

Sports medicine

PEEK-OPTIMA polymers feature mechanical properties that allow reliable arthroscopy applications such as suture retention for knotless suture anchors, tibial sheath and screw systems, and hand, foot & ankle applications.

Interested in evaluating
PEEK-OPTIMATM polymers for your next device?

Evidence in Spine & Orthopedic solutions

Text
Regulations
Compliance support for PEEK-OPTIMA™ devices under new EU Medical Device Regulations
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POHAE Histological Comparison
clinical study

PEEK-OPTIMA HA Enhanced Polymer Ovine Cervical Fusion Study 

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Medical-Parts
fact sheet

An introduction to PEEK-OPTIMA polymers

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PEEK-OPTIMA Knee
news

First Primary Total Knee Arthroplasty with the PEEK-OPTIMA™ Femoral Component

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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.
More than twenty years ago, the biocompatible PEEK-OPTIMATM 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.

All the benefits of PEEK-OPTIMATM Natural plus Hydroxyapatite (HA) crystals embedded throughout the material, a well-known osteo-conductive material. Unlike interbody fusion devices that are coated, PEEK-OPTIMATM 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 apposition1,
  • Greater new bone formation2
  • Higher quality of new bone bridging2.
PEEK-OPTIMATM Image Contrast offers all the performance advantages of the clinically proven and highly utilized PEEK-OPTIMATM 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.

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-OPTIMATM 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 

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-OPTIMATM 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).

References

1. IQVIA, Spinemarket Inc. 2018, Minneapolis, MN