NEW PRODUCTS / PRODUCT NEWS


Spinal Injection System

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.
Biologics & Spine, Carlisle Place
4721 Emperor Boulevard
Durham, NC 27703
phone (919) 474- 6700
fax (919) 474 6869
www.smith-nephew.com

Reference
1. Abdi S, Datta S, Trescot AM, et al. Epidural steroids in the management of chronic spinal pain: a systematic review. Pain Physician. 2007;10(1):185-212.


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
38 Sidney Street
Cambridge, MA 02139
phone (617) 577-7270
fax (617) 577-7170
www.etexcorp.com

Next-Generation Radiofrequency Electrode

DePuy Mitek, Inc., has launched the VAPR® Premiere90, a new low-profile, small-diameter radiofrequency electrode designed to provide fast and efficient soft-tissue ablation and coagulation with enhanced visualization during arthroscopic surgery.

The VAPR Premiere90 offers a low-profile design (3.3-mm tip and 3.7-mm shaft) aimed at allowing for easy insertion, maneuverability, and access to small or constricted areas, and its large active element surface area provides fast, efficient ablation and coagulation. DePuy Mitek notes that, at its default power setting, the device ablates hard tissue more than 20% faster than comparable electrodes.1

The central and new peripheral suction ports create a large suction area that improves visualization by quickly removing bubbles and small debris from the field of vision. Four raised areas on the face of the electrode provide tactile feedback, allowing the surgeon to know what tissue is being contacted and ablated.

Using the VAPR Premiere90, surgeons can independently adjust energy settings to optimize power for faster ablation or controlled coagulation. An integrated hand piece reduces the number of required connections in the operating room.

The VAPR Premiere90 is part of the VAPR Electrosurgical System, which includes the VAPR Premiere50 knee electrode for efficient anterior cruciate ligament (ACL) removal and meniscal sculpting, sealing, and shaping. The company notes that more than 20 additional electrodes of various lengths, sizes, and angles address a variety of surgical preferences and clinical needs.

The VAPR Electrosurgical System consists of a high-frequency electrosurgical generator, a reusable handpiece with connector cable, disposable electrodes, alternative disposable electrodes with integrated connector cable, and a foot switch. It is intended for resection, ablation, excision, hemostasis of blood vessels, and coagulation of soft tissue in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow, and/or wrist.

To learn more, contact

DePuy Mitek, Inc.
325 Paramount Drive
Raynham, MA 02767
phone (800) 382-4682
www.depuymitek.com

Reference
1. Data on file at DePuy Mitek.