Cranial LOOP

The first 100% PEEK cranial fixation device

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Click to know more aboutCranial LOOP (L)andCranial LOOP (XL)

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The first 100% PEEK cranial fixation device

Cranial LOOP is the first-ever cranial fixation device totally made of PEEK.

With its small size (12 mm diameter), the 2nd generation of Cranial LOOP is ideal to strongly fix the bone flap through the craniotomy gap, and at the same time minimize the amount of implanted material, particularly in the epidural region.

Instrument-free

Cranial LOOP is implanted with no additional instruments. Its unique design makes it a self-cutting device. The surgeon totally controls the bone flap fixation, which is achieved through its fast and easy "pull-and-tighten" action. Using three Cranial LOOPs, a standard bone flap is fixed in less than a minute.

Implantation of Cranial LOOP

CT / MRI Artifact-free

Cranial LOOP is totally made of PEEK-OPTIMA®. This makes it completely artifact-free in different medical imaging systems, such as X-rays, CT scanning and MRI.

Cranial LOOP is totally artifact-free

High Strength and Safety

NEOS' engineers have developed a unique design which guarantees that Cranial LOOP provides the same fixation strength as similar metallic non-instrument-free cranial fixation devices.

Strength of Cranial LOOP

The 2nd generation of Cranial LOOP has been designed to resist the same forces as equivalent titanium devices. The graph above compares the behaviour of Cranial LOOP and homologous systems in a test in which a bone flap was sank 2 mm into the skull (maximum limit tolerated in vivo).

3D Adaptation

Cranial LOOP perfectly adapts to the shape and curvature of the skull, thus guaranteeing the minimal possible profile at both the epidural and epicranial surfaces of the skull.

Cranial LOOP's minimal profile

See more details in this video.

 Product combination

All members of the Cranial LOOP family can be used either in combination or stand-alone. Thus, neurosurgeons can combine them in the way that best fits each specific craniotomy.

See several examples of possible combinations in the gallery below:

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Clinical and Functional Studies

Cranial LOOP is backed by the following scientific publications:

Article in Minimally Invasive Neurosurgery

Van Loock et al. Cranial bone flap fixation using a new device (Cranial LoopTM). Minim Invasive Neurosurg. 2011; 54 (3): 119-24

Describes the outcome of 35 consecutive patients in which Cranial LOOP was implanted.

Poster for the European Society for Biomaterials

Poster presented at the 24th Meeting of the European Society for Biomaterials (Dublin, 2011).

Describes the key characteristics that PEEK-OPTIMA® gives to the Cranial LOOP family: excellent mechanical behaviour, total lack of artifacts in medical imaging and optimal performance in radiotherapy.

♦ Click to know more about the excellent results of Cranial LOOP (user satisfaction 8/10) in an ongoing clinical trial.

Medical Design Excellence Awards winner

Medical Design Excellence Awards Winner Cranial LOOP was awarded the Gold recognition at the 2011 edition of the MDEA.

USA FDA RX-only

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