Mesh+tiles+skull Banner_2

OSSDSIGN® Cranial bringing life
to cranioplasty

OSSDSIGN® Cranial PSI (patient-specific implant) represents an innovative and insightful approach to cranioplasty. Uniquely designed for every single patient, OSSDSIGN Cranial reconstructs the skull defect, protects the brain and enhances the patient's cosmetic appearance. Delivered sterile and ready to use, in any size* or shape desired, it provides a solution for a variety of cranioplasty needs.

* < 200 cm2


THE CHALLENGE

Eliminate lifelong risks

Conventional cranioplasty using autologous bone and traditional synthetic implants pose a number of substantial risks and complications including resorption (autologous bone), infection and protrusion1-6

OSSDSIGN Cranial Implant

Ossdsign's SOLUTION

OSSDSIGN® Cranial PSI is a patient-specific implant based on a biocompatible calcium phosphate composition with a strong titanium skeleton embedded in the core of its' ceramic tiles.

OSSDSIGN® Cranial PSI is intended for the reconstruction of cranial defects. It is indicated for non-load bearing applications for patients in whom cranial growth is complete, and for use with an intact dura, with or without duraplasty.

features

outstanding mechanical properties

The design of OSSDSIGN® Cranial is based on a series of titanium-reinforced calcium phosphate tiles. The reinforcing titanium in OSSDSIGN® Cranial has been shown to withstand a force greater than that of a conventional titanium mesh.

innovative material and design

OSSDSIGN® Cranial PSI is composed of OssDsign's biocompatible calcium phosphate-based ceramic material. It is designed as a set of interconnecting tiles with inter-tile spacing that enables fluid movement through the device.

Easy and reliable ordering, handling and fixation

OSSDSIGN Cranial is easy to fixate to the skull with standard micro screws through the pre-designed, low-profile fixation arms. The titanium skeleton is embedded in the core of the implant's ceramic tiles which are manufactured, cured and immobilized - ready for surgery.

The OssDsign CAD-design team have extensive experience in designing implants for cranial defects of various complexity. During the design process we work in close collaboration with you to ensure that we achieve an optimal solution for you and your patient. 

Always read Instructions for Use which accompany the product for indications, contraindications, warnings and precautions


OSSDSIGN Cranial is labeled MR Conditional; see the 'MR Safety Information' in the Instruction for Use.
For more information please contact OssDsign at info@ossdsign.com or 011-46-18 55 39 93.

References
 1. Lee L, et al. (2013) A retrospective analysis and review of an institution’s experience
 with the complications of cranioplasty. Br J Neurosurg 27(5):629–635
 2. Walcott BP, et al. (2013) Predictors of cranioplasty complications in stroke and
 trauma patients. J Neurosurg 118(4):757–762
 3. Wachter D, et al. (2013) Cranioplasty after decompressive hemicraniectomy:
 underestimated surgery associated complications? Clin Neurol Neurosurg
 115(8):1293–1297
 4. Coulter I, et al. (2014) Routine but risky: A multi-centre analysis of the outcomes of
 cranioplasty in the Northeast of England. Acta Neurochir 156:1361–1368
 5. Thien A, et al. (2015) Comparison of Polyetheretherketone and Titanium Cranioplasty
 after Decompressive Craniectomy. World Neurosurg. 2015 Feb;83(2):176-180
 6. Bobinski L, et al. (2013) Complications following cranioplasty using autologous bone
 or polymethylmethacrylateretrospective experience from a single center. Clin Neurol
 Neurosurg 115(9):1788–1791