What improvement does Cranial LOOP offer compared with other current cranial fixation systems?

Cranial LOOP is fast and easy. With a simple “pull and tighten” movement, the device is implanted without the need for additional instruments. Furthermore, it is 100% radiolucent, which means that it is compatible with magnetic resonance imaging and CT scans.

Is it as strong as the metallic cranial fixations?

The design has been adapted to the special features of polymeric materials (PEEK-OPTIMA®) using the strength of this material such as its flexibility. Its innovative design allows fixation strengths similar to those of currently available metallic devices and in some cases even improves them.

Where can I find it?

Cranial LOOP is available in the following countries: Spain, Greece, Germany, the Netherlands, Belgium, Switzerland, France and Austria. It will also be available in Norway, Sweden, Finland, Italy and Denmark in the months to come.

How does the Cranial LOOP benefit the surgeons?

The main benefit for the surgeons provided by the Cranial LOOP is that it is instrument-free. This includes: a) being able to fasten the Cranial Loop without requiring any instrumentation, b) being able to “feel” the fixation, pulling on the handle to obtain the desired fixation, c) the self-cutting feature which gives a very low profile finish without any instrumentation and d) easy revision surgery without specific instrumentation. Furthermore, the handle and applier can be cut off the rest of the implant using standard OR equipment such as scissors, or rongeurs, without risk of becoming blunt. Moreover, the Cranial Loop is completely radiolucent. These aspects would be impossible with metallic biomaterials.

What are the patient benefits of the Cranial LOOP?

The benefits for the patients are: a) less risk of soft tissue damage (brain, dura mater or skin) due to less aggressive material and design (3D Adaptation) b) less risk of infection thanks to Cranial LOOP’s Instrument-free feature c) radiolucency allowing complete visibility of the operated area without any CT scan/MRI artefact, d) reduction of stress-shielding or mechanical mismatch between patient bone and the implant, e) no thermal mismatch, and f) easy revision surgery because PEEK does not tend to attach to the tissue.

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