Published 11/1/2007

Tools and Technology Update

FDA clears low-dose X-ray imager
Biospace med announced that it has received 510k clearance from the Food and Drug Administration (FDA) to market EOS, a new digital X-ray imager in the United States for 2D imaging use. According to the company, the EOS 2D|3D technology allows images to be obtained with a low dose of radiation and is capable of long length digital imaging, permitting full-body, uninterrupted digital imaging with a single scan. The simultaneous biplane image acquisition (front and side images acquired at the same time) eliminates the need for taking a second view and can save time.

The company is also developing an advanced workstation for the U.S. market, designed to generate a 3D skeletal reconstruction from the two simultaneous planar images. This planned product will also feature automatic measurement software designed to calculate a variety of measurements and angle calculations between individual bones and joints, potentially helping to evaluate global balance and posture. EOS 3D is currently commercially available in Europe and Canada only and is not part of the current FDA clearance.

Learn more at http://www.biospacemed.com.

Study finds once-yearly osteoporosis drug reduces fractures
Results of the first ever clinical study in osteoporosis patients who have had a hip fracture show that a once-yearly infusion of Reclast® (zoledronic acid) injection reduced the risk of subsequent fractures by 35% compared to placebo. The study also found a significant reduction in the risk of death.

The study, which included more than 2,100 men and women, was published in The New England Journal of Medicine and presented simultaneously at the annual meeting of the American Society for Bone & Mineral Research. The international, multicenter, randomized, double-blind, placebo-controlled Phase III study was designed to evaluate the efficacy and safety of Reclast in preventing subsequent fractures in men and women following the surgical repair of a low-trauma hip fracture (i.e., a fall from standing height or less or equivalent force). It is part of the Novartis HORIZON clinical trial program.

Reclast received FDA approval on August 17, 2007, as a treatment for postmenopausal osteoporosis. For more information, visit www.reclast.com or call (866) RECLAST (866-732-5278).

FDA clears new implant for marketing
Small Bone Innovations, Inc. (SBi), a single-source provider of products, technology, and education for the small bone and joint sector of the orthopaedic industry, announced that its Artelon® STT Spacer has been cleared by the FDA for marketing in the United States.

The Artelon STT Spacer is implanted in the scapho-trapezio-trapezoidial (STT) joint between the scaphoid and trapezial-trapezoid bones near the base of the thumb. Although similar in size to the Artelon CMC Spacer LG, the Artelon STT Spacer has a “single-wing” design (an L-shape vs. a T-shape), of woven, degradable Artelon fibers. The spacer is designed to preserve the STT joint and to help restore joint function while minimizing the need to sacrifice healthy bone and tissue.

The Artelon® CMC Spacer Arthro, cleared for marketing by the FDA earlier this year, permits minimally invasive arthroscopic implantation in patients at the earliest surgical stages of the condition.

For more details on Artelon products marketed by SBi, visit www.totalsmallbone.com.

New device helps repair meniscus tears in knee
The U.S. Food and Drug Administration has approved a new knee surgery device to help repair meniscus tears. Researchers at the University of Missouri developed the BioDuct Meniscal Fixation Device, which preserves the meniscus. The device will allow the meniscus to heal and restore knee function by transporting blood and cells from the vascular portion of the knee to the avascular portion of the meniscus.

JCR issues call for presentations
Joint Commission Resources (JCR) is now accepting proposals for presentations for the 2008 Ambulatory Care Conference. This marks the first time that JCR, a not-for-profit affiliate of The Joint Commission, has issued a call for presentations for its 13th annual ambulatory care conference.

Presentations at the Oct. 2-3, 2008, conference in Chicago will focus on “best practices” to create a culture of quality and safety improvement in ambulatory care settings, including primary care and surgery centers. Presentation proposals should address new processes, technologies, and tools that provide creative, innovative methods for addressing quality and safety issues. All proposals should be submitted for consideration by Dec. 20, 2007.

Presentation proposals will be reviewed by Conference Planning Advisory Members and presenters will be invited in February 2008. Additional information about the conference and proposal guidelines can be found by calling Leslie LaBelle, associate director of Conferences for JCR at (630) 792-5435 or by e-mailing ambulatorypost2008@jcrinc.com