Cizeta Surgical announced that it will be completing the study of SKULL GRIP by December 2009.
SKULL GRIP is a device that helps in fixation of the bone flaps during cranial procedure. It is intended for use in brain surgery. It consists of two wired (empty) parts: one part is circumferential and the other one semicircular. Each has a diameter of 16 mm connected by a wire thick 0.8 mm and high 4, 6, 8 and 10 mm and stretchable between 2.5 and 3 mm. It is manufactured with titanium ASTM F 136, grade 3.7165, tensile min 860, max 9999 Mpa to achieve optimal biocompatibility and resonance imaging (MRI) and computed tomography (CT) scan compatibility.
Bone flaps after craniotomy are typically fixed with suture material, mini plates and others devices. In some cases, fixation with suture material is not secure as it may result in shifting of the bone flap with its dislocation. In this study the safety and efficacy of SKULL GRIP a new device for fixation of the bone flap during cranial procedure comparing to traditional suture materials will be tested.
The 16 patient, phase I study is not yet open for participant recruitment. The official title of the study is “Implant System for Fixation of Cranial Bone Flaps After Craniotomy for Brain Surgery”.