Reduce pain following lumbar spine surgery
Even with the best surgical technique, postoperative pain, neurological symptoms, and other long-term complications can still occur after spine surgery. Fziomed’s absorbable gel products are the leading choice of spine surgeons worldwide, backed up by more than two decades of clinical experience improving patient outcomes and preserving surgical excellence.
Formulated specifically for spine surgery, Oxiplex® absorbable gel acts as a temporary, protective barrier to coat and protect sensory nerves from surrounding tissues and inflammatory mediators during the body’s natural healing process.
More than 800,000 spine patients treated since 2002
What is Oxiplex?
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Product Overview
Oxiplex is intended to be placed around neural tissues following lumbar spine surgery to
reduce leg pain and neurological symptoms.
Oxiplex gel is supplied sterile, ready to use in a 3 mL syringe with a flexible applicator.
Reduce Pain, Improve Outcomes
Oxiplex has been shown to significantly reduce pain* following spinal surgery.
This can lead to higher patient satisfaction and may help reduce the risk of long-term complications, including Failed Back Surgery Syndrome (FBSS).
1,2,3
Demonstrated Safety and Effectiveness
With over 20 years of clinical use, Oxiplex has been demonstrated safe and effective in more than 750,000 spinal procedures worldwide, supported by numerous published clinical studies. Our proprietary dual-polymer formulation contains no pharmaceutical agents and no materials of human, animal, or bacterial origin.
Ease of Use
Oxiplex is provided sterile and ready to use – no mixing required – and conveniently stored at room temperature. The prepackaged, flexible applicator allows for easy application, while the clear absorbable gel maintains operative site visibility.
Patient Satisfaction
Reducing postoperative leg pain and neurological symptoms can lead to improved patient satisfaction and outcomes.
Stability
Oxiplex gel’s unique viscosity is flowable yet remains where applied with no change in volume that could adversely affect nearby tissue or nerves.
Oxiplex is an FDA De Novo device. It is a synthetic, absorbable gel intended as an adjunct to lumbar spinal surgery in adult patients with leg pain, back pain, and neurological symptoms undergoing discectomy to reduce leg pain and neurological symptoms. Oxiplex should only be used after hemostasis during wound closure in adult patients. It is supplied sterile, for single use only, should not be re-used or sterilized, and should not be used in the presence of infection. Healthcare professionals should refer to the Instructions for Use for a complete list of Contraindications, Warnings and Precautions.
Caution: Federal law restricts this device to sale by or on the order of a physician.
References
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Oxiplex Absorbable Gel for Spine Surgery Instructions for Use, Clinical Summary.
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Rhyne A, et al. Oxiplex reduces leg pain, back pain and associated symptoms following lumbar discectomy. Spine 2012;37:631-641.
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Assietti R, et al. Use of carboxymethylcellulose/polyethylene oxide gel in microdiscectomy with interlaminectomy, a case series comparison with long-term follow-up. Spine 2008;33:1762-1765.
*Compared to surgery alone at 6 months in patients with severe leg and back pain prior to surgery.