New Products/Products News
Smith & Nephew Biologics & Spine has launched a new system for performing transforaminal epidural injections. The TRUCATH™ Spinal Injection System is designed to help reduce the risks1 associated with epidural pain management procedures. The design enables the physician to position the needle outside the bony structure of the spine, accurately delivering the catheter to the correct transforaminal entry point and reducing the potential for venous and arterial trespass.
The TRUCATH device has been licensed to Smith & Nephew in an exclusive global agreement with Laurimed, a privately owned medical device company based in Redwood City, California. It has received FDA clearance for use in injections into the epidural space. The new injection system is available immediately in the United States.
For more information about the new TRUCATH system, visit www.trucath.com.
Smith & Nephew Inc.
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Bone Graft Substitute
ETEX Corporation, an advanced-biomaterials company, announced additional FDA 510(k) cleared indications for EquivaBone®. ETEX notes that EquivaBone was the first FDA-cleared hard-setting osteoinductive material and is the only osteoinductive bone graft substitute that provides a continuous nanocrystalline calcium phosphate scaffold.
EquivaBone is now additionally indicated for use in posterolateral spine fusion, providing spine surgeons with a product that combines the certified osteoinductivity of demineralized bone matrix (DBM) with the optimal handling and hard-setting characteristics of the clinically proven ETEX calcium phosphate osteoconductive scaffold.
In addition, the FDA clearance allows EquivaBone to be mixed with autologous blood, adding greater procedural flexibility. The resultant viscous putty can then be molded and packed or injected into a defect.
EquivaBone is a proprietary combination of osteoinductive DBM and ETEX’s osteoconductive nanocrystalline calcium phosphate. ETEX points out that this is the first combination product that is both moldable and injectable and that sets hard once implanted. The osteoinductivity of the DBM is certified after sterilization, by lot, for the entirety of shelf life.
For more information, contact
ETEX Corporation
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