Implantable Medical Grade PEEK Polymer

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Implantable PEEK

Innovative medical grade PEEK-OPTIMA^TM materials that can help you to bring leading edge devices to market

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Materials & Solutions

Implantable PEEK

Overview

Medical-grade PEEK: a proven implantable polymer

The PEEK-OPTIMA^TM family of products is available in a wide variety of forms making it one of the most versatile biomaterial solutions available to medical device designers for long-term implantable solutions.

20+

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Years of proven clinical history

Our revolutionary PEEK-OPTIMA polymers are established as being a safe, long-term implantable polymer that can meet the needs of medical device manufacturers, surgeons and patients

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Zero material-related recalls

With approximately 15 million devices implanted worldwide, Invibio is a leading provider of proven and trusted PEEK-OPTIMA™ polymer based solutions for implantable medical devices

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Excellent mechanical properties

Excellent mechanical properties such as stiffness, toughness and durability, and a modulus close to that of natural cortical bone

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Used in medical devices cleared globally

Used in medical devices cleared globally , including US FDA 510(k), CE-marked and other regulatory bodies.

Regulatory support

Medical-grade, biocompatible PEEK polymer materials

Our wide range of biocompatible polymer materials and compounds are each designed to meet the specific and rigorous demands of implantable medical devices. PEEK materials are tailored to offer superior performance in a variety of applications including spine, orthopedic, trauma, dental and specialty devices. Innovative PEEK materials and our in-depth manufacturing knowledge combined with application expertise supports medical device companies to bring leading edge devices to market and open up new areas of growth.

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APPLICATIONs

Transformative PEEK implant material for medical applications

Spine & Orthopedics

Our biocompatible PEEK-OPTIMA^TM polymers are a leading choice for applications including spinal interbody fusion devices & anterior cervical plates

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Trauma

Delivering next generation technologies for fracture fixation and reducing implant failure, our carbon fiber composite trauma solutions are benefiting patients worldwide with a less stiff material compared to metal

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Medical devices

Short and long-term implantable solutions for cardiovascular, neurological and connected drug delivery devices such as diabetes management and respiratory devices

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Dental

Shock absorbing, durable and lightweight biomaterials for restorative and prosthetic dentistry, that offer a more natural dental solution than metals and ceramics

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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.

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.

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.

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.

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

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).

From concept to commercialization

Meeting the needs of medical device companies, surgeons and patients

Invibio is committed to developing solutions that can bring significant advantages
for patients and surgeons. We are more than a biomaterials provider; we are a
partner that can add value to all stages of a medical device product lifecycle.