Long-Term Safety and Performance of a Polymeric Clamplike Cranial Fixation System

Asencio-Cortés, Carlos; Salgado-López, Laura; Hernández, Fernando Muñoz; Quintana-Schmidt, Cristian de; Rodríguez-Rodríguez, Rodrigo; Álvarez-Holzapfel, María Jesús; Conesa, Gérardo

doi:10.1016/j.wneu.2019.02.146

Cited by 8 publications

(6 citation statements)

References 16 publications

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“…The method used in this article's cases proposes an interesting alternative that tackles most of the abovementioned issues. Cranial LOOP™ is generally praised for its ease of use, avoiding the use of complex instrument kits that require sterilization [2,3]. The risks of cranial fixation complications such as bone resorptions, skin erosion, or bone flap depression are significantly reduced when using Cranial LOOP™ thanks to the design of this device.…”

Section: Discussionmentioning

confidence: 99%

“…By pulling on the handle and pressing gently on the applier of the device, the two platforms are tightened together. The main advantages of Cranial LOOP™ over other bone flap fixations are the following: (a) it ensures a stable fixation with a very simple technique, (b) it requires no other surgical instrument to perform this fixation, (c) PEEK-Optima™ is not radiopaque, which ensures artifact-free radiological images [3], and (d) PEEK-Optima™ has a lower impact on the radiotherapy dose applied in areas nearby an implant than titanium, reducing the need for corrections when performing radiotherapy in the area below the craniotomy [4]. Cranial LOOP™ comes in three different sizes according to the diameter of the platforms: 12 mm (regular size) and 16 mm (L size) only for bone flap fixation and 22 mm (XL size) to cover burr holes in addition to fixing the bone flap.…”

Section: Introductionmentioning

confidence: 99%

“…In addition, it has been reported that Cranial LOOP™ offers excellent cosmetic results [3], which makes it a particularly optimal system to close frontal craniotomies as it avoids any bulges or cosmetic disturbances that have been commonly reported for the use of plates and screws. However, according to its instructions for use, Cranial LOOP™ should not be used on the base of the skull.…”

Section: Introductionmentioning

confidence: 99%

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Use of Clamp-Like Devices to Fix Bifrontal Basal Craniotomies: Three Case Reports

Gomez de la Riva

2024

Cureus

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The three case reports presented here provide clinical evidence of a configuration to easily and successfully fix bifrontal basal craniotomies with a clamp-like fixation device (Cranial LOOP™, NEOS Surgery, Barcelona, Spain): A 72-year-old woman undergoing resection of a meningioma at the sphenoidal level, a 43-year-old man undergoing clipping of an anterior communicating artery aneurism, and a 55-year-old woman undergoing macroscopical resection of a meningioma on the olfactory groove had their surgery performed through a bifrontal basal craniotomy, and, once the intervention was completed, the fixation of the cranial flap was performed using Cranial LOOP™, with a configuration consisting of two Cranial LOOP™ L at the basal lateral level and two additional products at the posterior frontal level. The result of this fixation was very satisfactory with no settling or artifacts during the follow-up. These cases show that Cranial LOOP™ can be used to fixate bifrontal basal craniotomies.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Use of Clamp-Like Devices to Fix Bifrontal Basal Craniotomies: Three Case Reports

Gomez de la Riva

2024

Cureus

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“…However, PEEK is also a non-absorbable material, and from the standpoint of infection, our method is more advantageous. [ 2 ] On the other hand, absorbable skull fixation materials are generally expensive, whereas titanium plates are superior in terms of cost-effectiveness. The CranioFix Absorbable system is available at a low cost in Japan, and the price of one CranioFix Absorbable is almost the same as the price of titanium plates and screws combined [ Table 2 ].…”

Section: Discussionmentioning

confidence: 99%

Rigid but nonmetallic cranioplasty after pterional craniotomy: Technical note

Sanada,

Tsuji,

Hamada

et al. 2023

Surgical Neurology International

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Background: Given the popularity of pterional craniotomy, numerous modifications have been made to prevent postoperative deformities. With the advent of titanium plates, fixation has become both simple and excellent. However, titanium plates can cause skin problems, infection, or cause skull growth to fail. Methods: To develop a simple, cost-effective, and esthetically satisfactory fixation method, without the use of non-metallic materials, six young and older patients underwent pterional craniotomy. CranioFix Absorbable clamps were used to fix the bone flap in the frontal and temporal regions such that the frontal part was in close contact with the skull. After fixation, the bone chips and bone dust were placed in the bone gap and fixed with fibrin glue. We measured the computed tomography values of the reconstructed area and thickness of the temporal profiles postoperatively over time. Results: Bone fusion was achieved in all patients by 1 year after surgery. Both the thickness of the temporalis muscle and the thickness of the temporal profile had changed within 2 mm as compared with the preoperative state. Conclusion: Our simple craniotomy technique, gentle tissue handling, and osteoplastic cranioplasty yielded satisfactory esthetic results and rigidness in pterional craniotomy.

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“…It is worth noting that in a craniotomy fixed with the Cranial LOOP system, the XL size could be used for both covering and fixing the bone flap 17 ; however, Cranial COVER would be of use for an aesthetic cover of the burr hole in a craniotomy fixed with plates and screws.…”

Section: Discussionmentioning

confidence: 99%

Safety and Performance of a New Burr Hole Covering Device: Results of the Multicenter COVER Registry

Asencio-Cortés

Villalba

Vilalta

et al. 2022

J Neurol Surg A Cent Eur Neurosurg

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Background: Burr-hole covering in brain surgical procedures can avoid complications and unaesthetic results. Study Aim: The aim of this registry was to assess the safety and performance of a new polymeric burr hole covering device (Cranial COVER, NEOS Surgery). Patients and Methods: A multicentere, prospective, clinical registry was used for the study. All patients that fulfilled inclusion criteria were included in the study and followed up for 6 months. Baseline clinical parameters, surgical variables (technical success of the implantation, surgeon satisfaction), post-operative variables (aesthetic and functional results, neuroimage artifacts) and adverse events were evaluated. Results: Forty-three Cranial COVER devices were implanted in 30 patients. Most of them were implanted in frontal locations (53.5%). After implantation, 97.7% of the devices completely covered the burr hole, and 100% perfectly adapted to the skull surface. All surgeons ranked their satisfaction with the implantation procedure as very high or high. No artifacts were detected in any of the neuroimages performed and no adverse events related with the device or its implantation were reported during the follow-up. There were significantly more scalp depressions associated with uncovered than with Cranial COVER-covered burr holes (P=0.040). Patient satisfaction with covered burr holes located in frontal and parietal areas was 9.0±1.4 over 10. Conclusion: Cranial COVER is a safe and reliable burr hole covering system that offers excellent cosmetic results and high satisfaction rates for both surgeons and patients. Cranial COVER is highly adaptable to the skull surface, and it was predominantly used in frontal locations due to their cosmetic importance.

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Long-Term Safety and Performance of a Polymeric Clamplike Cranial Fixation System

Cited by 8 publications

References 16 publications

Use of Clamp-Like Devices to Fix Bifrontal Basal Craniotomies: Three Case Reports

Use of Clamp-Like Devices to Fix Bifrontal Basal Craniotomies: Three Case Reports

Rigid but nonmetallic cranioplasty after pterional craniotomy: Technical note

Safety and Performance of a New Burr Hole Covering Device: Results of the Multicenter COVER Registry

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