Cranial LOOP

Product catalog summary

Overview: The document describes the Cranial LOOP family of cranial fixation devices, designed for securely fixing bone flaps resulting from craniotomies. These devices are characterized by their high strength, safety, and ease of use.

Specifications:

Osteotomy line devices available in 16 mm and 12 mm diameters with a 1 mm profile.
Burr hole device with a 22 mm diameter and 0.9 mm profile.
Made from 100% PEEK-OPTIMA™, ensuring CT/MRI artifact-free imaging.

Key Features:

Double locking mechanism for enhanced safety.
Instrument-free, allowing fast and easy implantation.
Minimal profile guaranteed by 3D adaptation.
Supplied sterile and ready to use, reducing OR time and logistics.
Compatible with bone thicknesses between 1.5 and 24 mm.

Clinical and Functional Studies:

Studies by Van Loock et al. and Vilana et al. highlight the effectiveness of the Cranial LOOP compared to traditional titanium devices.
Long-term safety and performance confirmed by Asencio et al.

Certifications:

PEEK-OPTIMA™ polymer certified under ISO 10993 standards and US FDA Drug & DMF.
CE-mark and FDA clearance obtained.

Advantages:

Reduces risk of soft tissue damage due to less aggressive material.
Easy removal with standard neurosurgery tools.
Equivalent fixation strength to standard metallic devices.

Awards: The Cranial LOOP received the MDEA Gold distinction in NYC, USA.

Distribution and Manufacturing:

Distributed by NEOS Surgery S.L. in Spain.
Manufactured under reference codes FC050000, FC050100, and FC050200.

Catalog excerpts

REINVENTING CRANIAL FIXATIONS HIGH STRENGTH & SAFETY Double locking mechanism INSTRUMENT-FREE Fast & Easy implantation CT/MRI ARTIFACT-FREE 100% PEEK-OPTIMA™ MINIMAL PROFILE Guaranteed by 3D adaptation BURR HOLE • Burr hole device • 22 mm diameter • Proﬁle: 0.9 mm • Osteotomy line device • 16 mm diameter • Proﬁle: 1 mm • Osteotomy line device • 12 mm diameter • Proﬁle: 1 mm CLINICAL AND FUNCTIONAL STUDIES Asencio, C. et al. Long-Term Safety and Performance of a Polymeric Clamp-Like Cranial Fixation System. World Neurosurg 2019; 126: e758-e764 Cranial LOOP was awarded the MDEA Gold distinction (NYC-USA) Van Loock, K. et al. “Cranial Bone Flap fixation using a New Device (Cranial Loop )”, Minim Invas Neurosurg 2011; 54:119-124 Vilana, X. et al. “Comparison between PEEK and Titanium cranial fixation devices”, Proceedings of the 24th European Conference on Biomaterials (Se

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GENERAL INFORMATION Savings in OR time, sterilisation and logistics • Supplied ready to use: sterile, no instrument tray needed. • Artifact-free in X-Ray, CT scan and MRI. • Reduced risk of soft tissue damage due to the smart design and less aggressive material: PEEK-OPTIMA™. • Can be used for bone thicknesses between 1.5 and 24 mm. • Easy to remove using standard Neurosurgery forceps or rongeurs. • PEEK-OPTIMA™ polymer is certified for implantation under ISO 10993 standards and US FDA Drug & DMF. • CE-mark and FDA clearance. NEOS SURGERY and Cranial LOOP are trademarks of NEOS SURGERY S.L. PEEK...

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Cranial LOOP

Cranial LOOP

Catalog excerpts

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