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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.
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.
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.
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.
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).
Furthermore, Cranial LOOP shows excellent behaviour at impact, thanks to its inherent elasticity and flexibility.
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.
See more details in this video.
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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Cranial LOOP is backed by the following scientific publications:
Poster presented at the 2014 Annual Meeting of the European Association of Neurosurgical Societies (EANS 2014, Prague).
Describes the results obtained in a randomized clinical trial: neurosurgeons are highly satisfied (approval above 80%) with Cranial LOOP. Click for more details.
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 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.
|Cranial LOOP was awarded the Gold recognition at the 2011 edition of the MDEA.|
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