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
Daniel Jones is CTO of EngineerBetter, helping enterprises deliver value faster. Previously he was an IT consultant, indie video games developer, head of web development in the finance sector, and an award-winning martial artist. Continuous Delivery makes it possible to exploit findings of cognitive psychology and neuroscience to increase the productivity and happiness of our teams.
There is a huge demand for responsive, real-time mobile and web experiences, but current architectural patterns do not easily accommodate applications that respond to events in real time. Common solutions using message queues or HTTP long-polling quickly lead to resiliency, scalability and development velocity challenges. In his session at 21st Cloud Expo, Ryland Degnan, a Senior Software Engineer on the Netflix Edge Platform team, will discuss how by leveraging a reactive stream-based protocol,...
Enterprises have taken advantage of IoT to achieve important revenue and cost advantages. What is less apparent is how incumbent enterprises operating at scale have, following success with IoT, built analytic, operations management and software development capabilities - ranging from autonomous vehicles to manageable robotics installations. They have embraced these capabilities as if they were Silicon Valley startups.
The standardization of container runtimes and images has sparked the creation of an almost overwhelming number of new open source projects that build on and otherwise work with these specifications. Of course, there's Kubernetes, which orchestrates and manages collections of containers. It was one of the first and best-known examples of projects that make containers truly useful for production use. However, more recently, the container ecosystem has truly exploded. A service mesh like Istio addr...
DXWorldEXPO LLC announced today that Kevin Jackson joined the faculty of CloudEXPO's "10-Year Anniversary Event" which will take place on November 11-13, 2018 in New York City. Kevin L. Jackson is a globally recognized cloud computing expert and Founder/Author of the award winning "Cloud Musings" blog. Mr. Jackson has also been recognized as a "Top 100 Cybersecurity Influencer and Brand" by Onalytica (2015), a Huffington Post "Top 100 Cloud Computing Experts on Twitter" (2013) and a "Top 50 C...
As DevOps methodologies expand their reach across the enterprise, organizations face the daunting challenge of adapting related cloud strategies to ensure optimal alignment, from managing complexity to ensuring proper governance. How can culture, automation, legacy apps and even budget be reexamined to enable this ongoing shift within the modern software factory? In her Day 2 Keynote at @DevOpsSummit at 21st Cloud Expo, Aruna Ravichandran, VP, DevOps Solutions Marketing, CA Technologies, was jo...
Predicting the future has never been more challenging - not because of the lack of data but because of the flood of ungoverned and risk laden information. Microsoft states that 2.5 exabytes of data are created every day. Expectations and reliance on data are being pushed to the limits, as demands around hybrid options continue to grow.
Business professionals no longer wonder if they'll migrate to the cloud; it's now a matter of when. The cloud environment has proved to be a major force in transitioning to an agile business model that enables quick decisions and fast implementation that solidify customer relationships. And when the cloud is combined with the power of cognitive computing, it drives innovation and transformation that achieves astounding competitive advantage.
Poor data quality and analytics drive down business value. In fact, Gartner estimated that the average financial impact of poor data quality on organizations is $9.7 million per year. But bad data is much more than a cost center. By eroding trust in information, analytics and the business decisions based on these, it is a serious impediment to digital transformation.
Digital Transformation: Preparing Cloud & IoT Security for the Age of Artificial Intelligence. As automation and artificial intelligence (AI) power solution development and delivery, many businesses need to build backend cloud capabilities. Well-poised organizations, marketing smart devices with AI and BlockChain capabilities prepare to refine compliance and regulatory capabilities in 2018. Volumes of health, financial, technical and privacy data, along with tightening compliance requirements by...
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 settlement products to hedge funds and investment banks. After, he co-founded a revenue cycle management company where he learned about Bitcoin and eventually Ethereal. Andrew's role at ConsenSys Enterprise is a mul...
"NetApp is known as a data management leader but we do a lot more than just data management on-prem with the data centers of our customers. We're also big in the hybrid cloud," explained Wes Talbert, Principal Architect at NetApp, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
"Since we launched LinuxONE we learned a lot from our customers. More than anything what they responded to were some very unique security capabilities that we have," explained Mark Figley, Director of LinuxONE Offerings at IBM, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
I love the beginning of the year. It is always enjoyable to see people's predictions for trends in the coming year. Publications like Fortune, CNN Money, Washington Post and the Atlantic speculate about what gadgets and technologies are going to take off in popularity this year, psychics predict which celebrities will have babies and fall in love, and I start to think about trends like DevOps and where the software delivery industry is headed next.CollabNet, Eric Robertson, predicted.
DXWordEXPO New York 2018, colocated with CloudEXPO New York 2018 will be held November 11-13, 2018, in New York City and will bring together Cloud Computing, FinTech and Blockchain, Digital Transformation, Big Data, Internet of Things, DevOps, AI, Machine Learning and WebRTC to one location.