Friday, September 29, 2017

PEEK Performance Biomaterial of Choice

For Clariance Spine
Since the late 1990s when highly pure and implantable grade of polyetheretherketone, known as PEEK-OPTIMA, gained acceptance for medical device implantation, the use of PEEK has grown to a point that it may be considered the material of choice, particularly for spinal implants. (published site)

In a medical device-network interview by Nic Paton, Dr. Steve Kurtz, corporate vice president and the director of Exponent’s Biomedical Engineering practice explains how and why that has come about.

Dr. Kurtz is also a part-time research professor and director of the Implant Research Center at Drexel University’s School of Biomedical Engineering, Science, and Health Systems. His expertise is in the clinical performance of polyethylene, ceramic, and metal-on-metal hip implants.

Since its invention by the aerospace industry, polyetheretherketone (PEEK) as a material that combines flexibility, strength, and stability at high temperatures made it an obvious choice for adaptation to medical uses.

Following development in the 1980s with experimental medical devices, Dr. Kurtz said clinical studies in the 1990s led to widespread clinical acceptance, especially in the field of spine implants.

He noted that the benefits of PEEK in spinal cages alone have led an industry segment now worth over $1 billion, and the majority of that is PEEK. This rapid rise to prominence, Dr. Kurtz said coincided with expansion of, and advances in surgical interventions for spinal diseases.

As a result, PEEK is now used in a wide range of procedures including spinal fusion, minimally invasive fusion surgery, motion preservation and dynamic stabilization, pedicle-based rod systems for non-fusion, interspinous spacers, and disc arthroplasty.

Part of the reason for that, Dr. Kurtz says is that traditionally implant devices were fabricated from metallic biomaterials, including stainless steel and titanium alloy, because of their strength and resistance to fatigue.

One of the main drawbacks of metallic materials, however is their incompatibility with diagnostic imaging, including MRI and CT scans, essential for visualizing changes to the spinal cord and soft tissue structures of the spine. PEEK polymer-based devices have been a key solution to this problem.

On the other hand, one of the drawbacks to PEEK has been its lack antibacterial activity and binding ability to natural bone tissue. However, Dr. Kurtz sees tremendous potential in overcoming these drawbacks pointing to experiments embedding calcium phosphate and hydroxyapatite within PEEK to promote bone ongrowth. Other approaches are looking at blending PEEK with synthetic hydroxyapatite whiskers or by using agents that increase the porous surface of PEEK to further encourage bone ingrowth.

Add to that is research looking at ways of making PEEK anti-bacterial by incorporating nano-silver, or other anti-bacterial formulations will further enhance PEEK’s appeal among spine surgeons.

So what, then, is the future of PEEK?

Dr. Kurtz says PEEK has the potential, for example, to be injection moldable, so it could be very amenable to high-throughput manufacturing and even micromolding. In short, he thinks PEEK can simply provide more value and flexibility for implants, as well as be a potential replacement for metal implants.

Clariance’s line of PEEK-OPTIMA spinal implants are made to provide the highest level of performance and durability and designed to create favorable conditions to optimize bone fusion. We are committed to developing further advances in PEEK devices as well as innovative solutions to provide patients with optimal outcomes.

Source: medicaldevice-network.com

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