Depuy Spine Launches Confidence™ System For Vertebral Compression Fractures At Spineweek

Main Category: Bones / Orthopaedics
Also Included In: Medical Devices
Article Date: 02 Jun 2008 - 2:00 PDT

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DePuy Spine, Inc., a Johnson & Johnson company, announced the worldwide launch of the CONFIDENCE SPINAL CEMENT SYSTEM™, a novel treatment for vertebral compression fractures, a painful condition that occurs when one or more vertebrae collapse, usually as a result of osteoporosis.

The announcement was made here during SpineWeek, a scientific meeting that brings together leading spine societies from the around the world.

According to the National Osteoporosis Foundation (NOF), more than 550,000 people get vertebral compression fractures in the United States each year and more than 10 million Americans have osteoporosis.

The CONFIDENCE System consists of a proprietary hydraulic-based delivery system that provides precise placement of a specially formulated high viscosity polymethylmethacrylate (PMMA) bone cement directly into vertebral bodies to stabilize fractures and to potentially reduce pain.

"The CONFIDENCE System addresses several important clinical needs for the treatment of vertebral compression fractures increasing procedure efficiency and precision," said Sylvain Palmer, MD, University of California, Irvine and Mission Hospital and Regional Medical Center.

The CONFIDENCE Spinal Cement System is easy to use, has a very short mixing time, and the dough-like consistency of the CONFIDENCE High Viscosity Cement provides a controlled, more even fill than low viscosity cement.[1]

CONFIDENCE achieves high viscosity immediately after mixing and stays at a constant high viscosity for nine minutes, allowing for optimal working time. The high viscosity properties of the CONFIDENCE Cement are designed to allow for interdigitation, preserving the remaining trabecular structure of the vertebral body.

The unique hydraulic-based delivery system allows the high viscosity cement to flow easily through a long, thin introducer needle and into the fracture site. The system also allows delivery and control outside the fluoro field reducing radiation exposure to the surgeon.

"DePuy Spine has worked very hard to bring a solution to the marketplace that provides a novel approach to one of the most common problems facing people with vertebral compression fractures," said Gary Fischetti, Worldwide President, DePuy Spine. "Advancing the treatment solutions for the aging spine has been a major focus for our organization and the CONFIDENCE System is just one of many products we have introduced to establish a leading position in this marketplace."

Vertebral compression fractures may only produce modest back pain at first, but can become severe over time. Multiple fractures may result in loss of height and dowager's hump, an abnormal forward curvature of the spine that causes a hunchback-like appearance and in some cases, difficulty breathing.

Vertebral compression fractures may be caused by specific injury or very slight force, such as turning, bending, standing or even sneezing because bones are weak and thin from osteoporosis. These fractures may also be caused by tumors or trauma. If a fracture occurs, doctors recommend conservative treatments such as bed rest, medications and physical therapy. If those fail, vertebral body augmentation may be recommended to reduce the pain and improve mobility.

Treating osteoporosis can prevent vertebral compression fractures from occurring by helping to strengthen bones. In addition, regular exercise, including muscle strengthening can decrease vertebral fractures and back pain.

According to the National Osteoporosis Foundation, 50 percent of all women and 25 percent of all men age 50 and older in the U.S. will have an osteoporosis fracture in their lifetime.

All medical procedures have potential risks. Patients should consult with their doctors to determine if vertebroplasty is appropriate for them. For more information about the CONFIDENCE System, please visit http://www.confidencespinalcement.com.

[1] G.Baroud, M. Crookshank, M.Bohner, Spine 31, 2562 (2006)

About DePuy Spine

DePuy Spine, Inc. has worked and partnered with leading clinicians, researchers, and thought leaders to develop products to treat spine disorders for over 20 years. Today, DePuy Spine stands in the forefront of the worldwide spine market, with a substantial sales organization in the U.S. and an expanding worldwide distribution network. The company is committed to advancing the knowledge of all health care professionals and their patients in addressing spinal pathologies.

DePuy Spine, Inc.