Welcome!

News Feed Item

New Implant Shows Promise for Painful Osteoporotic Spine Fractures

Results in 300 Patients Suggest Vertebral Augmentation Device Offers First New Treatment Option in Decade for Individuals With Compression Fractures

SAN DIEGO, March 24, 2014 /PRNewswire-USNewswire/ -- Individuals suffering from spinal fractures—caused by osteoporosis or weakened bones—now have another option to reduce pain, restore function and improve quality of life, according to a study of 300 patients treated with a new type of vertebral augmentation. Results of a randomized, controlled multicenter trial on a new implant treatment for vertebral compression fractures are being reported for the first time at the Society of Interventional Radiology's 39th Annual Scientific Meeting.

Society of Interventional Radiology

Made of medical polymer, the implant is designed to treat painful and debilitating vertebral compression fractures, which cause the bones in the spine to collapse and, left untreated, can lead to pain and a condition called kyphosis (or a curvature of the spine). Recently cleared by the U.S. Food and Drug Administration (FDA), the implant provides a new treatment alternative to vertebroplasty and kyphoplasty, the current standards of care. The implant was shown to meet or exceed the performance of kyphoplasty on every measure studied.

"This the first new method of treating these painful fractures in a decade, which is great news for patients because it not only helps restore quality of life, but it also was shown to outperform our most-used treatment in important ways," said Sean M. Tutton, M.D., FSIR, lead author of the study and professor of radiology, medicine and surgery at Medical College of Wisconsin in Milwaukee. "This Level 1 trial, which provides the highest quality and most reliable data, is one of the largest to date to compare a new treatment for vertebral compression fractures to standard of care—and the results match or exceed those of the current treatment," said Tutton. "This research also adds to the growing body of evidence supporting the efficacy and safety of these treatments," he added.

"Interventional radiologists are leading the way in providing minimally invasive treatment innovations for the spine, including developing new technologies that show significant patient benefits," said SIR President Scott C. Goodwin, M.D., FSIR. The Society recently published a multisociety position statement on vertebral augmentation, discussing current and future technologies and noting that augmentation is a safe, effective and durable treatment in appropriate patients, added Goodwin, Hasso Brothers' Professor and chair of radiological services at the University of California Irvine (UCI) School of Medicine.

Kiva System as a Vertebral Augmentation Treatment—A Safety and Effectiveness Trial (KAST) was a study conducted with FDA approval in which 153 patients with one or two painful osteoporotic vertebral compression fractures received the new implant and 147 had balloon kyphoplasty. Patients were treated at one of 21 centers in the United States, Canada, Belgium, France and Germany and were followed for one year. Results of the study confirmed that the implant provided essentially the same amount of pain relief and improvement in daily function based on accepted measures for pain and function (visual analogue score, VAS; Oswestry Disability Index, ODI) and safety. Researchers also found patients who had the implant were more likely to benefit from a reduction in the angle of the kyphosis and less likely to have the bone cement leak. Moreover, the study showed a clinically important trend in that the implant patients were less likely to suffer a fracture in adjacent vertebra. This latter finding is despite the fact that the 153 patients who received the implant had higher risk predictors for future fractures.

There are approximately 700,000 osteoporosis-related vertebral compression fractures in the United States every year, which is only expected to continue growing as the population ages, said Tutton. Treatment options include pain medications and bed rest, or now one of three image-guided minimally invasive treatments often performed by an interventional radiologist or interventional neuroradiologist: vertebroplasty, balloon kyphoplasty and the placement of this new implant. The implant is designed to provide structural support to the vertebral body and a reservoir to direct and contain bone cement. "We are moving away from traditional vertebroplasty or balloon-based vertebral augmentation, which relies solely on the administration of bone cement. This new approach allows the treating doctor to deliver a much more predictable supportive structure into the vertebrae," said Tutton.

More information about the Society of Interventional Radiology, finding an interventional radiologist in your area and minimally invasive treatments can be found online at www.SIRweb.org.

Abstract 238: "KAST Study: The Kiva® System as a Vertebral Augmentation Treatment—A Safety and Effectiveness Trial," S.M. Tutton, M.D., FSIR, Medical College of Wisconsin, Milwaukee; R. Pflugmacher, M.D., Universitätsklinikum Bonn, Germany; M. Davidian, M.D., Radiological Associates of Sacramento, Calif.; D. Beall, M.D., Clinical Radiology of Oklahoma, Edmond; F.R. Facchini, M.D., FSIR, Vascular and Interventional Radiology Associates, Hinsdale, Ill.; C. Nutting Jr. DO, FSIR, Radiology Imaging Associates, Greenwood Village, Col.; J. Hierholzer, M.D., Klinikum Ernst von Bergmann gGmbH, Potsdam, Germany; D. Nguyen, M.D., Radiology, Penn State Hershey Medical Center, Pa.; R. Smith, M.D., radiology, Toronto Western Hospital, Ontario, Canada; F. Schils, Saint Joseph, Liege, Belgium; J. Rappaport, M.D., Sierra Regional Spine Institute, Reno, Nev.; P. Jarzem, M.D., Montreal General Hospital, Quebec, Canada; D.F. Kallmes, M.D., Mayo Clinic, Rochester, Minn.; J.A. Stone, Mayo Clinic Jacksonville, Jacksonville, Fla.; F. Komlos, El Camino Hospital, Mountain View, Calif.; J. Zucherman, M.D., St. Mary's Spine Center, San Francisco, Calif.; E. Kerr, M.D., Spine Institute of Louisiana, Shreveport; M. Alonzo, M.D., North Shore University Health System, Evanston, Ill.; H. Deramond, M.D., Radiology, CHU Amiens, France; S.R. Garfin, M.D., Orthopedics, UC San Diego. SIR Annual Scientific Meeting, March 22–27. This abstract can be found at www.SIRmeeting.org

About the Society of Interventional Radiology
Interventional radiologists are physicians who specialize in minimally invasive, targeted treatments. They offer the most in-depth knowledge of the least invasive treatments available coupled with diagnostic and clinical experience across all specialties. Using X-ray, MRI and other imaging to advance a catheter in the body, such as in an artery, they treat disease at the source internally. As the inventors of angioplasty and the catheter-delivered stent, which were first used in the legs to treat peripheral arterial disease, interventional radiologists pioneered minimally invasive modern medicine. Many conditions that once required surgery can be treated less invasively by interventional radiologists. Interventional radiology treatments offer less risk, less pain and less recovery time compared to open surgery. Visit www.SIRweb.org. Follow SIR on Facebook and Twitter and use #SIR2014 to keep up with news from SIR 2014.

Logo - http://photos.prnewswire.com/prnh/20100127/SIRLOGO

SOURCE Society of Interventional Radiology

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
WebRTC sits at the intersection between VoIP and the Web. As such, it poses some interesting challenges for those developing services on top of it, but also for those who need to test and monitor these services. In his session at WebRTC Summit, Tsahi Levent-Levi, co-founder of testRTC, reviewed the various challenges posed by WebRTC when it comes to testing and monitoring and on ways to overcome them.
Have you ever noticed how some IT people seem to lead successful, rewarding, and satisfying lives and careers, while others struggle? IT author and speaker Don Crawley uncovered the five principles that successful IT people use to build satisfying lives and careers and he shares them in this fast-paced, thought-provoking webinar. You'll learn the importance of striking a balance with technical skills and people skills, challenge your pre-existing ideas about IT customer service, and gain new in...
SYS-CON Events announced today that Catchpoint Systems, Inc., a provider of innovative web and infrastructure monitoring solutions, has been named “Silver Sponsor” of SYS-CON's DevOps Summit at 18th Cloud Expo New York, which will take place June 7-9, 2016, at the Javits Center in New York City, NY. Catchpoint is a leading Digital Performance Analytics company that provides unparalleled insight into customer-critical services to help consistently deliver an amazing customer experience. Designed ...
SYS-CON Events announced today that CA Technologies has been named “Platinum Sponsor” of SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY, and the 21st International Cloud Expo®, which will take place October 31-November 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. CA Technologies helps customers succeed in a future where every business – from apparel to energy – is being rewritten by software. From ...
Tintri VM-aware storage is the simplest for virtualized applications and cloud. Organizations including GE, Toyota, United Healthcare, NASA and 6 of the Fortune 15 have said "No to LUNs." With Tintri they manage only virtual machines, in a fraction of the footprint and at far lower cost than conventional storage. Tintri offers the choice of all-flash or hybrid-flash platform, converged or stand-alone structure and any hypervisor. Rather than obsess with storage, leaders focus on the business app...
The financial services market is one of the most data-driven industries in the world, yet it’s bogged down by legacy CPU technologies that simply can’t keep up with the task of querying and visualizing billions of records. In his session at 20th Cloud Expo, Jared Parker, Director of Financial Services at Kinetica, will discuss how the advent of advanced in-database analytics on the GPU makes it possible to run sophisticated data science workloads on the same database that is housing the rich inf...
DevOps is often described as a combination of technology and culture. Without both, DevOps isn't complete. However, applying the culture to outdated technology is a recipe for disaster; as response times grow and connections between teams are delayed by technology, the culture will die. A Nutanix Enterprise Cloud has many benefits that provide the needed base for a true DevOps paradigm.
Ayehu provides IT Process Automation & Orchestration solutions for IT and Security professionals to identify and resolve critical incidents and enable rapid containment, eradication, and recovery from cyber security breaches. Ayehu provides customers greater control over IT infrastructure through automation. Ayehu solutions have been deployed by major enterprises worldwide, and currently, support thousands of IT processes across the globe. The company has offices in New York, California, and Isr...
LogMeIn has completed its previously disclosed merger with Citrix Systems, Inc.’s GetGo, Inc. subsidiary, a wholly owned subsidiary consisting of Citrix’s GoTo family of service offerings. The merger officially closed after market hours on January 31, 2017. Effected through a Reverse Morris Trust transaction, the merger brings together two of the preeminent players in cloud connectivity to instantly create one of the world’s top 10 public SaaS companies, and a market leader with the scale, resou...
In his session at @ThingsExpo, Steve Wilkes, CTO and founder of Striim, will delve into four enterprise-scale, business-critical case studies where streaming analytics serves as the key to enabling real-time data integration and right-time insights in hybrid cloud, IoT, and fog computing environments. As part of this discussion, he will also present a demo based on its partnership with Fujitsu, highlighting their technologies in a healthcare IoT use-case. The demo showcases the tracking of patie...
In his keynote at 18th Cloud Expo, Andrew Keys, Co-Founder of ConsenSys Enterprise, provided an overview of the evolution of the Internet and the Database and the future of their combination – the Blockchain. Andrew Keys is Co-Founder of ConsenSys Enterprise. He comes to ConsenSys Enterprise with capital markets, technology and entrepreneurial experience. Previously, he worked for UBS investment bank in equities analysis. Later, he was responsible for the creation and distribution of life settle...
The explosion of new web/cloud/IoT-based applications and the data they generate are transforming our world right before our eyes. In this rush to adopt these new technologies, organizations are often ignoring fundamental questions concerning who owns the data and failing to ask for permission to conduct invasive surveillance of their customers. Organizations that are not transparent about how their systems gather data telemetry without offering shared data ownership risk product rejection, regu...
The best way to leverage your Cloud Expo presence as a sponsor and exhibitor is to plan your news announcements around our events. The press covering Cloud Expo and @ThingsExpo will have access to these releases and will amplify your news announcements. More than two dozen Cloud companies either set deals at our shows or have announced their mergers and acquisitions at Cloud Expo. Product announcements during our show provide your company with the most reach through our targeted audiences.
Cloud Expo, Inc. has announced today that Aruna Ravichandran, vice president of DevOps Product and Solutions Marketing at CA Technologies, has been named co-conference chair of DevOps at Cloud Expo 2017. The @DevOpsSummit at Cloud Expo New York will take place on June 6-8, 2017, at the Javits Center in New York City, New York, and @DevOpsSummit at Cloud Expo Silicon Valley will take place Oct. 31-Nov. 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
SYS-CON Events announced today that Cloud Academy will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Cloud Academy is the industry’s most innovative, vendor-neutral cloud technology training platform. Cloud Academy provides continuous learning solutions for individuals and enterprise teams for Amazon Web Services, Microsoft Azure, Google Cloud Platform, and the most popular cloud computing technologies. Ge...