What is Cranial LOOP?

Cranial LOOP is a cranial fixation device used to fix a bone flap to the skull after a craniotomy. This device has been designed to be placed in the gap left between the flap and the skull without the need of any extra instruments. A strong fixation of the bone flap is guaranteed with the use of three Cranial LOOPs (one per side of the craniotomy).

What advantages does Cranial LOOP offer when compared with current cranial fixation systems?

Cranial LOOP is fast and easy to use: with a simple “pull and tighten” movement, the device is implanted without the need for any additional instruments. The inherent flexibility of its material ensures the perfect 3D adaptation of the device to the skull’s surface. Furthermore, it is 100% radiolucent, which means that it is compatible with magnetic resonance imaging and CT scans. In addition, Cranial LOOP’s unique features ensure an optimal performance in radiotherapy.

How is Cranial LOOP placed in the skull?

We recommend the use of one Cranial LOOP per side of the craniotomy. Once the devices have been placed, you just have to put the bone flap back in its original place, and adjust the Cranial LOOPs with the “pull and tighten” movement.

You can see the whole process in this video.

Is Cranial LOOP as strong as current metallic cranial fixations?

The design has been adapted to fit the special features of polymers (PEEK-OPTIMA^®), and we take advantage of the strong points of this material, such as its flexibility. This way, Cranial LOOP’s innovative design guarantees fixation strengths that are similar to those of currently available metallic devices, and in some cases improves them.

Where is Cranial LOOP currently distributed?

Cranial LOOP is available in over 20 countries in five continents. You can see the complete list of countries in which Cranial LOOP is distributed here.

How does Cranial LOOP benefit surgeons?

The main advantages that Cranial LOOP offers to the surgeons stem from it being instrument-free. This means that surgeons:

a) are able to fasten the Cranial LOOP without requiring any instrumentation,

b) are able to “feel” the fixation, pulling on the handle to obtain the desired fixation strength,

c) obtain a very low profile finish without any instrumentation, thanks to Cranial LOOP’s self-cutting feature, and

d) can perform an easy revision surgery without any additional 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, with no risk of them becoming blunt.

Finally, Cranial LOOP is completely radiolucent, and it is thus artifact-free both in CT and MR images. This would be impossible with similar metallic implants.

How does Cranial LOOP benefit  patients?

Patients who have had Cranial LOOP placed in their skull will benefit from:

a) a reduced risk of soft tissue damage (brain, dura mater or skin) due to its less aggressive material and design, which guarantees Cranial LOOP’s perfect 3D adaptation,

b) a decreased risk of infection, thanks to Cranial LOOP’s instrument-free feature,

c) complete visibility of the operated area without any CT scan or MRI artifact, thanks to Cranial LOOP’s radiolucency,

d) reduction of stress-shielding or mechanical mismatch between patient bone and the implant,

e) lack of thermal mismatch, and

f) easy revision surgery, because PEEK-OPTIMA^® does not adhere to the surrounding tissues.