Welcome!

News Feed Item

Independent Study Demonstrates Effectiveness of Kiva®System for Patients With Osteolytic Vertebral Metastases

Spine Study Shows Kiva Reduced Pain without Extravasation

SANTA CLARA, Calif., Feb. 25, 2014 /PRNewswire/ -- Benvenue Medical, Inc., today announced results of an independent, prospective, randomized study which found that the company's Kiva® VCF Treatment System was as effective as balloon kyphoplasty (BKP) in reducing pain associated with osteolytic vertebral body metastases. The Kiva System also resulted in no extravasation (cement leakage) while BKP, the current standard of care, showed a nearly 10 percent leakage rate. The results of the first head-to-head study of Kiva and BKP for this patient population were published online and in the Feb. 15 edition of the peer-reviewed journal Spine.

(Logo: http://photos.prnewswire.com/prnh/20140128/SF53909LOGO-b)

"Cement leakage is a common complication of balloon-assisted vertebral augmentation and can be disastrous for patients with bone metastases when it leaks into the spinal canal," said Panagiotis Korovessis, MD, PhD, Chief of the Department of Orthopaedic Surgery at General Hospital "Agios Andreas" in Patras, Greece, and lead author of the study. "This is the first study to show that the Kiva System is an effective alternative to BKP in providing spinal pain relief for these patients – and without the complication of cement leakage."

The study, titled "Is Kiva Implant Advantageous to Balloon Kyphoplasty in Treating Osteolytic Metastasis to the Spine? Comparison of 2 Percutaneous Minimal Invasive Spine Techniques," included 47 patients with 84 vertebral body osteolyses. Outcome measurements were vertebral body height, segmental kyphotic angle, extravasation rates, pain, function and quality of life. Results of the study include:

  • Kiva and BKP provided equally significant spinal pain relief one month postoperatively, as measured by the Visual Analogue Scale and Oswestry Disability Index (P<0.001).
  • No patients in the Kiva group experienced cement leakage, compared with 9.3% in the BKP group.
  • Kiva and BKP showed a tendency for restoration of anterior and posterior vertebral body height and kyphotic Gardner angle; only Kiva restored middle vertebral body height.
  • Both Kiva and BK safely augmented painful thoracic and lumbar vertebral osteolytic metastases; only Kiva additionally reinforced sacral metastases.

"This study adds to the body of literature demonstrating the effectiveness of the Kiva System, providing important insights for patients with cancer that has metastasized to the vertebra," said Robert K. Weigle, CEO of Benvenue Medical, Inc. "The Kiva System, which was cleared by the FDA in January, is continually proven to be an effective vertebral restoration treatment that reduces pain and improves quality of life for patients with cancer that has spread to the vertebra, but with the added patient benefit of reducing the risk of potential complications from cement leakage, which can be devastating."

About the Kiva VCF Treatment System

The Kiva VCF Treatment System provides a new, implant-based approach to vertebral augmentation in the treatment of painful VCFs. It is indicated for use in the reduction and treatment of spinal fractures in the thoracic and/or lumbar spine from T6-L5. It is intended to be used in combination with the Benvenue Vertebral Augmentation Cement Kit.

The Kiva System features a proprietary flexible implant made from PEEK-OPTIMA®, a biocompatible polymer that is widely used and well accepted as a spinal implant. The Kiva implant is designed to provide structural support to the vertebral body and a reservoir to direct and contain bone cement during vertebral augmentation. The implant is delivered percutaneously over a removable guidewire in a continuous loop into the vertebral body through a small diameter, single incision. The amount of the Kiva implant delivered is physician-customized during the procedure.

The Kiva System received 510(k) clearance from the U.S. Food and Drug administration in January 2014.  It is also available in Europe, where it is distributed by Zimmer.

About Benvenue Medical, Inc.

Founded in 2004, Benvenue Medical, Inc. develops next-generation, minimally invasive expandable implants for the spine. The company is privately held and funded by Versant Ventures, DeNovo Ventures, Domain Associates and Technology Partners.  Its first products are designed for the treatment of vertebral compression fractures and degenerative disc disease, which have combined revenues of $1.6 billion globally. For more information, visit www.benvenuemedical.com.

ML3437.A

MEDIA CONTACT:
Betsy Merryman
Merryman Communications
[email protected]
310-560-8176

SOURCE Benvenue Medical, Inc.

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
Containers, microservices and DevOps are all the rage lately. You can read about how great they are and how they’ll change your life and the industry everywhere. So naturally when we started a new company and were deciding how to architect our app, we went with microservices, containers and DevOps. About now you’re expecting a story of how everything went so smoothly, we’re now pushing out code ten times a day, but the reality is quite different.
The hierarchical architecture that distributes "compute" within the network specially at the edge can enable new services by harnessing emerging technologies. But Edge-Compute comes at increased cost that needs to be managed and potentially augmented by creative architecture solutions as there will always a catching-up with the capacity demands. Processing power in smartphones has enhanced YoY and there is increasingly spare compute capacity that can be potentially pooled. Uber has successfully ...
Using new techniques of information modeling, indexing, and processing, new cloud-based systems can support cloud-based workloads previously not possible for high-throughput insurance, banking, and case-based applications. In his session at 18th Cloud Expo, John Newton, CTO, Founder and Chairman of Alfresco, described how to scale cloud-based content management repositories to store, manage, and retrieve billions of documents and related information with fast and linear scalability. He addres...
You want to start your DevOps journey but where do you begin? Do you say DevOps loudly 5 times while looking in the mirror and it suddenly appears? Do you hire someone? Do you upskill your existing team? Here are some tips to help support your DevOps transformation. Conor Delanbanque has been involved with building & scaling teams in the DevOps space globally. He is the Head of DevOps Practice at MThree Consulting, a global technology consultancy. Conor founded the Future of DevOps Thought Leade...
When building large, cloud-based applications that operate at a high scale, it’s important to maintain a high availability and resilience to failures. In order to do that, you must be tolerant of failures, even in light of failures in other areas of your application. “Fly two mistakes high” is an old adage in the radio control airplane hobby. It means, fly high enough so that if you make a mistake, you can continue flying with room to still make mistakes. In his session at 18th Cloud Expo, Lee A...
While some developers care passionately about how data centers and clouds are architected, for most, it is only the end result that matters. To the majority of companies, technology exists to solve a business problem, and only delivers value when it is solving that problem. 2017 brings the mainstream adoption of containers for production workloads. In his session at 21st Cloud Expo, Ben McCormack, VP of Operations at Evernote, discussed how data centers of the future will be managed, how the p...
The deluge of IoT sensor data collected from connected devices and the powerful AI required to make that data actionable are giving rise to a hybrid ecosystem in which cloud, on-prem and edge processes become interweaved. Attendees will learn how emerging composable infrastructure solutions deliver the adaptive architecture needed to manage this new data reality. Machine learning algorithms can better anticipate data storms and automate resources to support surges, including fully scalable GPU-c...
Wooed by the promise of faster innovation, lower TCO, and greater agility, businesses of every shape and size have embraced the cloud at every layer of the IT stack – from apps to file sharing to infrastructure. The typical organization currently uses more than a dozen sanctioned cloud apps and will shift more than half of all workloads to the cloud by 2018. Such cloud investments have delivered measurable benefits. But they’ve also resulted in some unintended side-effects: complexity and risk. ...
Machine learning provides predictive models which a business can apply in countless ways to better understand its customers and operations. Since machine learning was first developed with flat, tabular data in mind, it is still not widely understood: when does it make sense to use graph databases and machine learning in combination? This talk tackles the question from two ends: classifying predictive analytics methods and assessing graph database attributes. It also examines the ongoing lifecycl...
With more than 30 Kubernetes solutions in the marketplace, it's tempting to think Kubernetes and the vendor ecosystem has solved the problem of operationalizing containers at scale or of automatically managing the elasticity of the underlying infrastructure that these solutions need to be truly scalable. Far from it. There are at least six major pain points that companies experience when they try to deploy and run Kubernetes in their complex environments. In this presentation, the speaker will d...
When applications are hosted on servers, they produce immense quantities of logging data. Quality engineers should verify that apps are producing log data that is existent, correct, consumable, and complete. Otherwise, apps in production are not easily monitored, have issues that are difficult to detect, and cannot be corrected quickly. Tom Chavez presents the four steps that quality engineers should include in every test plan for apps that produce log output or other machine data. Learn the ste...
Dhiraj Sehgal works in Delphix's product and solution organization. His focus has been DevOps, DataOps, private cloud and datacenters customers, technologies and products. He has wealth of experience in cloud focused and virtualized technologies ranging from compute, networking to storage. He has spoken at Cloud Expo for last 3 years now in New York and Santa Clara.
"Peak 10 is a hybrid infrastructure provider across the nation. We are in the thick of things when it comes to hybrid IT," explained , Chief Technology Officer at Peak 10, in this SYS-CON.tv interview at 20th Cloud Expo, held June 6-8, 2017, at the Javits Center in New York City, NY.
We are seeing a major migration of enterprises applications to the cloud. As cloud and business use of real time applications accelerate, legacy networks are no longer able to architecturally support cloud adoption and deliver the performance and security required by highly distributed enterprises. These outdated solutions have become more costly and complicated to implement, install, manage, and maintain.SD-WAN offers unlimited capabilities for accessing the benefits of the cloud and Internet. ...
Dion Hinchcliffe is an internationally recognized digital expert, bestselling book author, frequent keynote speaker, analyst, futurist, and transformation expert based in Washington, DC. He is currently Chief Strategy Officer at the industry-leading digital strategy and online community solutions firm, 7Summits.