Volume 5, Issue 2 (Spring 2019)                   Iran J Neurosurg 2019, 5(2): 54-62 | Back to browse issues page


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Ghodsi S R, Esmaili Dezaki H, Alizadeh M, Namazi Z. Post-Market Surveillance Study of a Skull Flap Fixation Device: Cranfixer. Iran J Neurosurg. 2019; 5 (2) :54-62
URL: http://irjns.org/article-1-156-en.html
1- CEO, DanaWell Company , roholahghodsi@gmail.com (Corresponding author)
2- Designer, DanaWell Company
3- Department of Tissue Engineering, School of Advanced Technologies, Shahrekord University of Medical Sciences, Shahrekord, Iran
4- R&D coordinator, DanaWell Company
Abstract:   (490 Views)
Background and Aim: Cranfixer was approved in 2017 by the Food and Drug Administration of Iran as a skull flap fixation and also a burr hole cover. The effectiveness and safety of this commercial medical device were investigated in detail by the regulatory auditors.
Methods and Materials/Patients: Cranfixer was used for ninety-five patients. Sixty patients were selected from a list if they had at least two follow-ups after surgery. The following variables were investigated: age, gender, number of Cranfixers, device loosening, infection, and prominence. In
addition, a retrospective review was performed about the reason of surgery.
Results: Flap loosening and infection were the major variables surveyed. On average, two Cranfixers were used for each patient. Patients’ median age was 44 years. There was no sex preference (50% male). The craniotomy occurred in the frontal (50%), occipital (3%), parietal (20%), and temporal (27%)
lobes. Based on examination and CT imaging, no cases of loosening were observed. Just in one patient, one of two Cranfixers was infected (P<0.001).
Conclusion: The reliability and functionality of Cranfixer were proved in pre-market test and the results of this study confirm them. Cranfixer provides safe, reliable and long-term functionality.
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Type of Study: Clinical Trial | Subject: Basic Neurosurgery

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