A prospective multicentric registry to assess the safety and performance of a polymeric cranial burr hole covering system: the cover registry
Asencio-Cortés C, Villalba G, De Vilalta A, Serrano L, Gabarrós A.
ONGOING (March,2020)
This is a multi-centric, prospective, post-marketing clinical registryto assess the safety and clinical performance of a new polymeric burr hole covering device (Cranial COVER, NEOS Surgery) in common neurosurgical practice.
Thirty-two patients have been included in the study (three Spanish centres), and 16 of them have already finished the 6 months follow-up. A total of 88 burr holes were performed in those patients, of which 43 were covered with Cranial COVER. After implantation, 97.4% of devices completely covered the burr hole, and 100% ended perfectly adapted to the skull surface. Surgeon satisfaction was very high (81%) or high (19%) in all the procedures. No adverse events related with the device or its implantation were reported. There were no scalp depressions in any of the covered burr-holes, while there where present in 80% of the uncovered burr-holes. Patients ranked 9.1±1.3 (over 10) its satisfaction with the cosmetic results.
Conclusion: Cranial COVER is a safe and reliable burr-hole covering system that offers excellent cosmetic results.
