FDA clears spine systems
The following spine devices have recently received clearance from the U.S. Food and Drug Administration (FDA):
- The A-Fix Spinal System from Aesculap Implant Systems is a stand-alone interbody fusion device developed for the anterior surgical approach. It is intended for spinal fusion procedures at one or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disk disease with up to Grade 1 spondylolisthesis at the involved level(s). For more information, visit www.aesculapimplantsystems.com
- Medyssey Spine’s Zenius™ Thoracolumbar Spinal System is a titanium alloy 5.5 mm rod and thoracolumbar pedicle screw construct for the surgical treatment of spinal trauma, deformity, and degenerative spinal pathologies. For more information, visit www.medyssey.com
- Mazor Surgical Technologies Ltd.’s combined spinal surgical system comprises the SpineAssist miniature robotic navigation system and the C-Insight 3D imaging system, which enables surgeons to perform 3D imaging during surgery. For more information, visit www.mazorst.com
- The CHESAPEAKE Anterior-Lumbar Stabilization System from K2M, Inc., is an interbody device designed for stabilization of the spine through an anterior approach. Through the use of proprietary locking technology, each screw head reportedly forms an autogenic lock to the implant upon insertion. For more information, visit www.K2M.com
- The Aesculap Implant Systems S4 Cervical Occipital Plating System is used to promote spinal fusion of the cervical and thoracic spine (C1-T3) and occipito-cervico-thoracic junction (occiput-T3) in patients with degenerative disease or fracture. For more information, visit www.aesculapimplantsystems.com
Negative pressure wound therapy for surgical incisions
The Prevena™ Incision Management System from KCI uses an integrated, one-piece dressing to cover and protect closed incisions from external infectious sources, while negative pressure removes fluid and potentially infectious material from the incision. Prevena is designed for linear incisions associated with general surgery, orthopaedic, Ob/Gyn, and cardiothoracic procedures.
For more information, visit www.KCI1.com
Upgraded prosthetic hand
The iLIMB Pulse from Touch Bionics is a myoelectric prosthetic hand that uses multi-articulating digits to provide users with a stronger and compliant grip. Available in two sizes for males and females, the iLIMB Pulse features improved design and functionality, including a pulsing motor for increased grip strength, an upgraded battery assembly for increased speed, automatic grips and gestures, and new BioSim software.
For more information, visit www.touchbionics.com/Pulse
Positioning system for obese patients
The MorphBoard® modular pegboard positioning system from Innovative Medical Products features two modular end boards and a lightweight, 20-inch wide center board that can be adjusted to accommodate a larger patient’s abdomen. When combined with the two end boards and rotated 90 degrees, the center board “morphs” into a 30-inch wide section large enough to support most obese patients.
Instead of lifting the patient, operating room personnel can roll patients onto their sides for stabilization using the various peg-hole locations. The 8-, 12-, and 14-inch pegs are available in aluminum or a radiolucent composite material that can be used with intraoperative X-rays.
For more information, visit www.innovativemedical.com
Tissue-sparing retraction system
The Integra LifeSciences iPASSAGE™ Retractor for minimally invasive surgery of the lumbar spine is a tissue-sparing retraction system that reportedly allows the surgeon to make smaller incisions, potentially reducing tissue damage, blood loss, and recovery time. The device is compatible with the Paramount® MIS Pedicle Screw System and the Coral™ Spinal System’s pedicle screws.
For more information, visit www.integra-ls.com
Knee brace boasts improved comfort, fit
The FUSION® XT knee brace from Breg (E) now features the AirTech™ system. AirTech is a system of air mesh vents and grooved channel frame pads designed to improve comfort and fit by increasing airflow throughout the brace and moving moisture away from the skin. The new pad technology is also designed to reduce pinching and help alleviate pressure points while adjustable/removable straps and pivot point strap tabs help ensure a proper fit.
For more information, visit www.breg.com
FDA clears modular total shoulder system
The TITAN™ Modular Total Shoulder System from Ascension Orthopedics, Inc., offers a bone-preserving option for patients needing total or hemi shoulder arthroplasty. According to the manufacturer, the system allows orthopaedic surgeons to independently select distal stems and proximal bodies that best match the patient’s anatomy and bone quality, and the fully interchangeable system allows all primary and fracture bodies to be used with either press-fit or cemented stems. The system also offers multiple glenoid options for patients needing total shoulder replacement.
For more information, visit www.ascensionortho.com