overview

Why PEEK is an Excellent Solution for sternal fixation devices

Stiffness similar to bone

Radiolucency and artifact-free imaging

Strong, durable and highly resistance to creep and fatigue

Design flexibility, precision machining, injection molding

benefits

Potential Benefits of PEEK Polymer Compared to Metal Implants

PEEK polymer is rapidly becoming a preferred material in the medical field, especially in orthopedic and spinal implants. Here's why PEEK stands out when compared to traditional metal sternal fixation devices:

1. Reduced Stress at the Bone-Implant Interface [2,4]	PEEK's unique properties lead to a more balanced stress distribution at the bone-implant interface. This reduces the risk of implant "cut through" and device failure, providing a more durable and long-lasting solution.
2. Enhanced Fusion Healing Assessment [5]	PEEK's radiolucent properties allow for clearer imaging during radiographic assessments, enabling better monitoring of fusion healing without the interference that often comes with metal implants.
3. CT and MRI Compatibility [5]	Unlike metal, PEEK is fully compatible with CT and MRI imaging. This eliminates the risk of imaging artifacts and allows for precise postoperative assessments, ensuring optimal patient care.
4. Easier Insertion [3]	The flexibility and smooth surface of PEEK implants make them easier to insert, reducing surgical time and potentially improving patient outcomes.
5. Simplified Revisions [4]	PEEK implants can be easily cut or burred during revision surgeries, making them more adaptable in complex cases where adjustments are necessary.
6. Lower Risk of Glove Puncture	When compared to metal wires, PEEK offers a significantly lower risk of surgical glove punctures, enhancing the safety of the surgical team.
7. Flexibility and Ease of Handling [3,4]	PEEK’s inherent flexibility makes it easier to handle during surgery, offering greater control and precision for surgeons.
8. Continuous Compression [2,4]	PEEK allows for continuous compression across the implant site, ensuring consistent pressure and stability, which can contribute to better long-term outcomes.

Launching a PEEK device?

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peek examples

PEEK is Fast Becoming an Alternative to Metals

The global sternal closure systems market was estimated at USD 1.7 billion in 2020 and is expected to grow at a CAGR of 5.6% from 2021 to 2028. Here are two examples of recently launched FDA-cleared devices that use PEEK-OPTIMA™:

KEY BENEFITS COMPARED TO METAL PLATES

Fast emergent re-entry, patient-specific contouring, improved visibility post-operatively with no imaging artifacts

Image: Valkyrie™ PEEK-OPTIMA™ Sternal Fixation plate system. © Able Medical 2022.

KEY BENEFITS COMPARED TO METAL WIRES

Continuous sternal compression, reduced risk of bone cut-through, lower risk of glove puncture and easy to us

Image: STERNFix™: PEEK-OPTIMA™ Carbon Fibre Reinforced Sternal Fixation system. © NEOS Surgery 2022.

RESOURCES

Further resources

PEEK-OPTIMA POLYMERs

An introduction to PEEK-OPTIMA polymers

Download brochure

regulatory support

Compliance support for PEEK-OPTIMA™ devices under new EU Medical Device Regulations

Download flyer

Surgeon opinion

“The best of all worlds”: A surgeon’s clinical experience with the PEEK-OPTIMA expandable interbody device

Read article

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References

1. Data available on file at Invibio.
2. Pouya Nezafati, et al. ZipFix Versus Conventional Sternal Closure: One-Year Follow-Up. Heart Lung Circ. 2019 Mar;28(3):443-449.
3. Ludovic Melly, et al. A new cable-tie-based sternal closure device: infectious considerations. Interact Cardiovasc Thorac Surg. 2013 Aug;17(2):219-23.
4. Martin TR Grapow, et al. A new cable-tie based sternal closure system: description of the device, technique of implantation and first clinical evaluation. J Cardiothorac Surg. 2012 Jun 25;7:59.
5. Kazuma Takashima, et al. A carbon fiber-reinforced polyetheretherketone intramedullary nail improves fracture site visibility on postoperative radiographic images. Injury. 2021 Aug;52(8):2225-2232.