OSTENE

Control of bone bleeding in orthopedic and cardiothoracic surgeries is essential to achieve successful outcomes and to provide a healthy recovery. OSTENE bone hemostat provides immediate bone hemostasis and facilitates natural bone healing after surgery.¹

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Image of Ostene being applied to the sternal edge

Immediate Bone Hemostasis

OSTENE provides immediate bone hemostasis and resorbs within 24-48 hours, facilitating the natural bone healing process.^1,2,3,7

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Image of thumb and index fingers holding Ostene product

Easy Application At Your Fingertips

The ready-to-use sticks are soft and easy to apply. Using dry, gloved fingers, OSTENE is easily molded to the desired shape and consistency that provides immediate hemostasis when pressed into bleeding bone.

Additional Product Benefits

Does Not Interfere With Bone Healing*

Preclinical studies on sternal, cranial and tibial animal bone healing show OSTENE facilitates normal osteogenesis while negligible healing is shown with bone wax.^2,3,4,6,7

*Preclinical data. Results may not correlate to performance in humans.

Does Not Increase Infection*

OSTENE does not increase infection rates, providing for a good alternative to bone wax when the risk of infection may be a concern.^2,4,5,6

Does Not Cause Chronic Inflammation*

In a preclinical model, OSTENE does not cause chronic inflammation, providing for a good alternative to bone wax when the risk of chronic inflammation may be a concern.^2,4

OSTENE [Bone Hemostasis Material] Indication

OSTENE Bone Hemostasis Material is indicated for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces. OSTENE Bone Hemostasis should be warmed to desired consistency using aseptic techniques.

Important Risk Information for OSTENE Bone Hemostasis Material

Do not use OSTENE Bone Hemostasis Material in sites with active or latent infections. OSTENE Bone Hemostasis Material is not intended for use in lending structural support to bone.

OSTENE Bone Hemostasis Material is provided sterile for single use only. DO NOT RESTERILIZE. Discard any open, unused, or damaged packages. DO NOT USE if there is a loss of sterility of the device. OSTENE Bone Hemostasis Material should not be subjected to excess heat. Store at room temperature away from direct heat, including sunlight.

Rx Only: For safe and proper use of this device please refer to full device instructions for use.

CE 0086

See References

Ostene Bone Hemostasis Material [instructions for use]. Los Angeles, Calif: Ceremed Inc.PN-26 CF607 Rev. H 2011.
Wellisz T, Armstrong JK, Cambridge J, Fisher TC. Ostene, a new water-soluble bone hemostasis agent. J Craniofac Surg. 2006;17:420-5.
Armstrong JK, Han B, Kuwahara K, et al. The effect of three hemostatic agents on early bone healing in an animal model. BMC Surg. 2010;10:37.
Wellisz T, An YH, Wen X, et al. Infection rates and healing using bone wax and a soluble polymer material. Clin Orthop Relat Res. 2008;466:481-6.
Singh-Joy SD, McLain VC. Cosmetic Ingredient Review, Washington, DC 20036, USA. Safety assessment of poloxamers 101, 105, 108, 122, 123, 124, 181, 182, 183, 184, 185, 188, 212, 215, 217, 231, 234, 235, 237, 238, 282, 284, 288, 331, 333, 334, 335, 338, 401, 402, 403, and 407, poloxamer 105 benzoate, and poloxamer 182 dibenzoate as used in cosmetics. Int J Toxicol. 2008;27 Suppl 2:93-128.
Wellisz T, Armstrong JK, Cambridge J, et al. The effects of a soluble polymer and bone wax on sternal healing in an animal model. Ann Thorac Surg. 2008;85:1776-80.
Magyar CE, Aghaloo TL, Atti E, Tetradis S. Ostene, a new alkylene oxide copolymer bone hemostatic material, does not inhibit bone healing. Neurosurgery. 2008;63:373-8; discussion 378.

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