Brochure PEEK-OPTIMA HA Enhanced Brochure Download

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PEEK-OPTIMA™ HA ENHANCED Advancing the Science of Fusion

Two clinically proven biomaterials, together in one innovative compound. Hydroxyapatite (HA), a well-known osteoconductive material that enhances bone apposition, has been completely integrated with PEEK-OPTIMA™, the leading PEEK-based biomaterial with over 15 years of clinical history.

PEEK-OPTIMA HA ENHANCED

PEEK-OPTIMA NATURAL

Mechanical Strength





Modulus Similar to Cortical Bone





Imaging Compatibility





Biocompatibility





Enhanced Bone Contact1



PEEK-OPTIMA HA Enhanced has similar properties to PEEK-OPTIMA Natural, but also encourages enhanced bone on-growth

Push Out Strength at 4 weeks 5

5

Bone Contact Comparison

4

4

3

3

Grading of bone-in-contact:

2

grade

Mean Grade

Shear Stress (MPa)

THE RESULT: a strong, versatile and highly effective biomaterial that offers a superior solution for bone apposition.1

2 1 0

12 weeks

4: 3: grade 2: grade 1: grade 0: grade

1 0

PEEK-OPTIMA Natural

PEEK-OPTIMA HA Enhanced

PEEK-OPTIMA HA Enhanced increases interfacial shear strength with bone 4 weeks following implantation1

4 weeks

PEEK-OPTIMA Natural

PEEK-OPTIMA HA Enhanced

PEEK-OPTIMA HA Enhanced promotes greater bone contact in vivo1

> 75% contact 50% 25% < 25% No direct contact

A material enhancement in spinal device technology. Spinal fusion continues to be the most popular procedure for treating spinal pathologies. Although published fusion rates for PEEK devices are high,2, 3 recently the trend for interbody fusion devices has been to look for ways to enhance bone apposition on the surface of the device. Invibio PEEK-OPTIMA™ HA Enhanced provides the accepted high performance characteristics of PEEK-OPTIMA Natural, the leading spinal interbody device material, plus Hydroxyapatite (HA) to enhance bone apposition. This new combination is a promising solution for medical applications where early bone on-growth is required, such as spinal interbody fusion.

PROPERTY

IMPACT STRENGTH (Notched Izod kJ/m2)

FLEX STRENGTH (MPa)

FLEX MODULUS (GPa)

TENSILE STRENGTH (MPa)

TENSILE ELONGATION AT BREAK (%)

PEEK-OPTIMA Natural

7.6

164

4.1

100

40

PEEK-OPTIMA HA Enhanced

5.6

155

4.9

92

18

2-5

173

18

80-150

1.4

Cortical Bone

(un-notched)

(longitudinal)

PEEK-OPTIMA HA Enhanced has mechanical properties similar to PEEK-OPTIMA Natural and a modulus closer to bone than does titanium, thus reducing stress shielding4

Fluorographic imaging of cervical interbody fusion devices. With a high degree of radiolucency and no imaging artifacts, PEEKOPTIMA HA Enhanced has similar visibility to PEEK-OPTIMA Natural.

PEEK-OPTIMA HA Enhanced PEEK-OPTIMA Natural

Superior surface coverage with an integrated compound. Hydroxyapatite (HA) is fully integrated, not coated, into the PEEK-OPTIMA Natural biomaterial to provide a complete homogenous compound, ensuring it is present on all surfaces of a machined device. This material innovation eliminates the investment of time and resources associated with applying a surface coating, and simplifies the validation process.

SCANNING ELECTRON MICROGRAPH: Well dispersed HA in the PEEK matrix HA available on all machined surfaces for enhanced bone-on growth Typical coating technologies only applied to vertebral body contact surfaces

Early bone apposition generates greater bone contact.1 Invibio PEEK-OPTIMA HA Enhanced Polymer demonstrates enhanced bone apposition within 4 weeks compared with PEEK-OPTIMA Natural in a pre-clinical in vivo study using a sheep model.1 PEEK-OPTIMA Natural

PEEK-OPTIMA HA Enhanced

PEEK-OPTIMA HA Enhanced

Areas of direct bone contact, but with some gaps

High degree of direct bone contact early in the healing process

Early bone mineralization (alizarin red labelling)

Enhanced bone contact continues at 12 weeks. Enhancements in bone apposition are maintained at 12 weeks following implantation left:

the blue arrows indicate gaps between the bone and implant. right:

the dashed line indicates continuous bone contact.

PEEK-OPTIMA Natural

PEEK-OPTIMA HA Enhanced

High performance in application-specific tests. Compressive strength tests using a generic cervical fusion device, and impact testing with a generic PLIF design, demonstrate that PEEK-OPTIMA HA Enhanced delivers the same high performance as PEEK-OPTIMA Natural – even after repeated sterilization.

Example of cage used in testing of static compressive strength

Static compressive strength 70000

Ultimate impact strength 5000

60000

4000 Peak Force (N)

50000 Force (N)

Example of cage used in ultimate impact strength testing

40000 30000 20000 10000

3000 2000 1000 0

0 Equivalent performance to PEEK-OPTIMA Natural in compressive strength testing following the principles of ASTM F2077 PEEK-OPTIMA Natural

Unconditioned

Steam Sterilized (30 cycles)

Equivalent ultimate impact strength to PEEK-OPTIMA Natural before and after repeated steam sterilization PEEK-OPTIMA HA Enhanced

Available only from Invibio – advancing the science of fusion. Consistent high-quality and performance. Reliable delivery. Simple processing that helps streamline production. PEEK-OPTIMA HA Enhanced expands upon the advantages Invibio has offered customers since transforming the spinal device industry with the introduction of the PEEK-OPTIMA polymer family over 15 years ago. Invibio continuously innovates and extends value-added services that support our customers in overcoming challenges in the ever-evolving spine industry.

To learn more about PEEK-OPTIMA HA Enhanced Polymer, visit InvibioSpine.com

Invibio Ltd. Technology Centre, Hillhouse International Thornton Cleveleys, Lancashire FY5 4QD United Kingdom Tel: +44 (0) 1253 898000 FAX: +44 (0) 1253 898001

Invibio Ltd. 300 Conshohocken State Rd West Conshohocken, PA USA 866-INVIBIO (468 4246) Tel: +484 342 6004 FAX: +484 342 6005

For further information call us toll free at 866-INVIBIO or +44 (0)1253 898000 or please visit our website at:

InvibioSpine.com REFERENCES 1. Study evaluated the bone on-growth of PEEK-OPTIMA 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 experience. 2. Niu et al. J Spinal Disord Tech. 2010;23(5):310-6. 3. Chou et al. J Clin Neurosci. 2008;15(11):1240-5 4. Values shown are typical material properties as moulded, and those shown for cortical bone are indicative of those found in the literature. Copyright © 2016 Invibio Ltd. INVIBIO™, PEEK-OPTIMA™, INVIBIO BIOMATERIAL SOLUTIONS™ are trademarks of Victrex plc or its group companies.

S-DP-PHA-E-0037-D (8/2016)

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Brochure PEEK-OPTIMA HA Enhanced Brochure Download

PEEK-OPTIMA™ HA ENHANCED Advancing the Science of Fusion Two clinically proven biomaterials, together in one innovative compound. Hydroxyapatite (HA...

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