Industry News

Pedicle screw receives FDA clearance for AIS
Medtronic, Inc., has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the TSRH® Spinal System pedicle screw for the treatment of adolescent idiopathic scoliosis (AIS). TSRH and CD HORIZON® pedicle screws are indicated for posterior use as an adjunct to fusion in the thoracolumbar spine when treating AIS. The safety and effectiveness of the TSRH and CD HORIZON spinal systems have not been established for use as part of a growing rod construct. They are only intended to be used when definitive fusion is being performed at all instrumented levels.

For more information, visit www.medtronic.com

Robotic arm-assisted technology for THA
MAKO Surgical’s RIO® Robotic Arm Interactive Orthopedic System (A) is now available for use in MAKOplasty® total hip arthroplasty (THA) procedures. The total hip replacement application is designed to support the surgeon’s ability to more accurately align and position the implants relative to the needs of a patient. MAKOplasty THA provides the surgeon with a preoperative 3-dimensional (3-D) reconstruction of the patient’s hip, which is used to develop the patient-specific surgical plan. The robotic arm then assists the surgeon during the procedure to accurately prepare the joint and optimally place hip implants.

For more information, visit www.makosurgical.com

Fixation implant system treats scoliosis in youths
Zimmer, Inc.’s Universal Clamp® Spinal Fixation System is now indicated for the treatment of idiopathic and neuromuscular scoliosis in patients 8 years of age or older. Designed for use in conjunction with spinal deformity procedures, the Universal Clamp Implant offers a pedicle-sparing approach for malformed or small thoracic pedicles, while reportedly still providing similar stability to pedicle screw constructs.

According to the manufacturer, the Universal Clamp band spreads contact forces over a greater surface area compared to wires and hooks, thereby reducing the risk of pulling through the lamina. Zimmer also states that the system’s reduction instrumentation enables surgeons to sequentially reduce deformity and spread the reduction forces over multiple levels.

For more information, visit www.zimmer.com

Minimally invasive system for 3-D spine correction
DePuy’s VIPER® 3D Minimally Invasive Surgery (MIS) Correction Set (B) is a surgical instrumentation system designed specifically for the minimally invasive 3-D correction of complex spinal deformities, such as AIS and adult degenerative scoliosis. The VIPER 3D Set consists of instrumentation and devices for a variety of correction maneuvers and techniques. The set includes the MIS Rod Inserter/Rotator for 360° correction, a spondy reduction lever to control sagittal alignment, derotation and correction frames, a multilevel compression and distraction device to control orientation at individual levels, and approximation tools for seamless rod reduction.

For more information, visit www.depuy.com

Wound dressing designed to reduce SSIs
SurgiClear from Covalon Technologies is a clear film dressing with an antimicrobial silicone adhesive especially designed to reduce instances of surgical site infections (SSIs). SurgiClear is reportedly the first transparent film dressing that allows clinicians and patients to monitor the healing process of surgical sites while providing effective antimicrobial protection for up to 7 days against the leading organisms that cause SSIs, with the aid of two antimicrobial compounds infused directly into the silicone adhesive.

For more information, visit www.covalon.com

Ultrasound-guided drug delivery system
The Navigator™ Delivery System (DS) (C) from Carticept Medical is a computer-controlled drug delivery system with integrated ultrasound guidance designed to increase the efficiency, accuracy, and safety of administering pain-relieving medications for joint pain. Designed for convenient operation by a single clinician, the Navigator DS prepares and delivers physician-prescribed injections from standard multidose anesthetic and steroid drug vials.

The system eliminates needle exposures to healthcare workers, minimizes the potential for contamination of the medication, and helps to ensure accurate dose preparation. The ultrasound screen provides the physician with real-time visualization of the needle position, fluid delivery process, and prescription volume. After the injection is delivered, the system records the treatment data and automatically creates a record for transfer to an electronic records management system.

For more information, visit www.carticept.com

Disposable bone fixation system
The Speed™ system from BioMedical Enterprises, Inc., is a fully disposable bone fixation system. The system includes a comprehensive series of shape memory bone fixation staple implants, in combination with single-use instruments. According to the manufacturer, the system’s disposable design prevents loss of instrumentation before and after surgery, eliminates instrument cleaning and sterilization, and reduces surgery time and operating room costs.

For more information, visit www.bme-tx.com

Mobile C-arm with flat detector
The Veradius Neo mobile C-arm (D) with flat detector from Philips is designed to allow surgeons to more easily and precisely handle challenging patients and procedures. The device’s new C-arc geometry is specially designed to accommodate even obese patients with increased maneuverability, providing more room for orthopaedic surgeons to work and to position around patients. The flat detector technology provides high-quality, undistorted images that surgeons use to help place screws and other devices with precision, states Philips.

For more information, visit www.usa.philips.com

AAOS Now
January 2012 Issue
http://www.aaos.org/news/aaosnow/jan12/marketplace1.asp