|By PR Newswire||
|January 6, 2014 07:00 AM EST||
SAN JOSE, Calif., Jan. 6, 2014 /PRNewswire/ -- SI-BONE, Inc. (San Jose, California), a medical device company that pioneered the use of the iFuse Implant System,® a minimally invasive surgical (MIS) device indicated for fusion of the sacroiliac (SI) joint, announced today that the iFuse Implant System has been used in over 10,000 procedures worldwide utilizing over 29,000 iFuse implants. Adoption of the MIS procedure continues to expand and now over 700 surgeons have performed the iFuse procedure in the U.S. and Canada as well as 13 European countries with 4 additional European countries expected to begin performing cases soon. Minimally invasive SI joint fusion is now considered the standard of care1 for patients suffering from degenerative sacroiliitis or sacroiliac joint disruptions who fail conservative therapy, and the iFuse, with its unique triangular-shape and porous titanium plasma spray (TPS) coating, is the clear market leader. In addition, the iFuse Implant System is the only MIS treatment option for which there are published peer-reviewed clinical data that support safety and effectiveness.2
SAN JOSE, Calif., Jan. 6, 2014 /PRNewswire/ -- SI-BONE, Inc. (San Jose, California), a medical device company that pioneered the use of the iFuse Implant System,® a minimally invasive surgical (MIS) device indicated for fusion of the sacroiliac (SI) joint, announced today that the iFuse Implant System has been used in over 10,000 procedures worldwide utilizing over 29,000 iFuse implants. Adoption of the MIS procedure continues to expand and now over 700 surgeons have performed the iFuse procedure in the U.S. and Canada as well as 13 European countries with 4 additional European countries expected to begin performing cases soon. Minimally invasive SI joint fusion is now considered the standard of care1 for patients suffering from degenerative sacroiliitis or sacroiliac joint disruptions who fail conservative therapy, and the iFuse, with its unique triangular-shape and porous titanium plasma spray (TPS) coating, is the clear market leader. In addition, the iFuse Implant System is the only MIS treatment option for which there are published peer-reviewed clinical data that support safety and effectiveness.2"10,000 procedures is truly a significant milestone for us to achieve and it is very gratifying to know that our technology has helped so many people. However, in spite of this significant achievement, we believe there are many more patients suffering from degenerative sacroiliitis or sacroiliac joint disruptions who have failed conservative therapy and we will continue to accelerate our leadership efforts to educate patients, health care professionals and insurers on the benefits of iFuse as a treatment option for these patients," said Jeffrey Dunn, President and CEO of SI-BONE.
Steven Garfin, MD, Distinguished Professor and Chairman, Department of Orthopedic Surgery, UC San Diego, said: "a little over four years ago, when I first learned about SI-BONE and the iFuse procedure, I was intrigued and thought this would potentially be something useful but only for a very limited number of patients. However, after a little over four years now and over 10,000 procedures, it is obvious that the SI joint disorders that are treatable with the iFuse are much more prevalent than previously recognized. SI-BONE has pioneered this new approach to treating the SI joint and the iFuse is the only MIS device that has published clinical safety and effectiveness evidence to support its use. I am impressed with the company's focus on patients."
SI-BONE, Inc. received original 510(k) clearance in November 2008 from the Food and Drug Administration (FDA) to market its iFuse Implant System (then called the "SI Joint Fusion System") for fracture fixation of long bones and large bone fragments of the pelvis for conditions including sacroiliac joint disruptions and degenerative sacroiliitis, and an additional clearance in April 2011 for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. The CE mark for European commercialization was obtained in November 2010.
Clinical publications have identified the SI joint as a pain generator for up to 22% of low back pain patients.5 In addition, DePalma et al, Pain Medicine 2011, identified the SI joint as a low back pain generator from 43% to 61% of post-lumbar fusion, so-called "failed back surgery," patients.6 Initial treatment options for patients with SI joint disorders typically involve non-surgical management and, when non-surgical treatment of the SI joint fails, surgical treatments such as the iFuse may provide an option.
The iFuse Implant System is a commercially available device in the U.S. and Europe. The iFuse procedure uses a small incision for delivery and implantation of titanium implants. The implants are coated with a porous, titanium plasma spray that acts as an interference surface, designed to help decrease implant motion and provide immediate fixation and allow for biological fixation to support long term fusion. These implants have substantial thickness and sophisticated metallurgy and are able to produce a much stronger construct than that of conventional screws used to surgically fix bony structures. The iFuse System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. As with all surgical procedures and permanent implants, there are risks and considerations associated with surgery and use of the iFuse Implant.
About SI-BONE, Inc.
SI-BONE, Inc. (San Jose, California) is the leading sacroiliac joint medical device company dedicated to the development of tools and products for diagnosing and treating patients with low back issues related to SI joint disorders. The company has developed, and is manufacturing and marketing, less invasive approaches using implants for the treatment of certain SI joint pathology. SI-BONE has an experienced management team with extensive experience in orthopedic and spine medical devices. SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. ©2014 SI-BONE, Inc. All Rights Reserved. 8568.112113
1International Society for the Advancement of Spine Surgery (ISASS) Consensus Statement, July 2013.
2 Graham Smith A, Capobianco R, Cher D, Rudolf L, Sachs D, Gundanna M, Kleiner J, Milan M, Shamie AN. Open versus Minimally Invasive Sacroiliac Joint Fusion: a Multi-Center Comparison of Perioperative Measures and Clinical Outcomes. Annals of Surgical Innovation and Research. 2013, 7:14
2 Duhon BS, Cher DJ, Wine KD, Lockstadt H, Kovalsky D, Soo CL. Safety and Six-Month Effectiveness of Minimally Invasive Sacroiliac Joint Fusion: A Prospective Study. Medical Devices: Evidence and Research. 2013;6:219-29
Dr. Garfin, Dr. Graham Smith, Dr. Rudolf, Dr. Sachs, Dr. Gundanna, Dr. Shamie and Dr. Duhon are paid consultants for SI-BONE. Dr. Rudolf, Dr. Sachs, Dr. Gundanna, Dr. Duhon, Dr. Lockstadt, Dr. Kovalsky and Dr. Soo are paid clinical research investigators for SI-BONE. Dr. Garfin, Dr. Rudolf and Dr. Shamie have an ownership interest in SI-BONE. R. Capobianco, Dr. Cher, and K. Wine are employees of SI-BONE.
SOURCE SI-BONE, Inc.
DevOps is being widely accepted (if not fully adopted) as essential in enterprise IT. But as Enterprise DevOps gains maturity, expands scope, and increases velocity, the need for data-driven decisions across teams becomes more acute. DevOps teams in any modern business must wrangle the ‘digital exhaust’ from the delivery toolchain, "pervasive" and "cognitive" computing, APIs and services, mobile devices and applications, the Internet of Things, and now even blockchain. In this power panel at @...
Oct. 22, 2016 07:45 PM EDT Reads: 1,812
Without lifecycle traceability and visibility across the tool chain, stakeholders from Planning-to-Ops have limited insight and answers to who, what, when, why and how across the DevOps lifecycle. This impacts the ability to deliver high quality software at the needed velocity to drive positive business outcomes. In his general session at @DevOpsSummit at 19th Cloud Expo, Eric Robertson, General Manager at CollabNet, will discuss how customers are able to achieve a level of transparency that e...
Oct. 22, 2016 07:00 PM EDT Reads: 757
SYS-CON Events announced today that SoftNet Solutions will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. SoftNet Solutions specializes in Enterprise Solutions for Hadoop and Big Data. It offers customers the most open, robust, and value-conscious portfolio of solutions, services, and tools for the shortest route to success with Big Data. The unique differentiator is the ability to architect and ...
Oct. 22, 2016 06:45 PM EDT Reads: 609
"Matrix is an ambitious open standard and implementation that's set up to break down the fragmentation problems that exist in IP messaging and VoIP communication," explained John Woolf, Technical Evangelist at Matrix, in this SYS-CON.tv interview at @ThingsExpo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Oct. 22, 2016 06:00 PM EDT Reads: 8,955
In past @ThingsExpo presentations, Joseph di Paolantonio has explored how various Internet of Things (IoT) and data management and analytics (DMA) solution spaces will come together as sensor analytics ecosystems. This year, in his session at @ThingsExpo, Joseph di Paolantonio from DataArchon, will be adding the numerous Transportation areas, from autonomous vehicles to “Uber for containers.” While IoT data in any one area of Transportation will have a huge impact in that area, combining sensor...
Oct. 22, 2016 05:30 PM EDT Reads: 479
Established in 1998, Calsoft is a leading software product engineering Services Company specializing in Storage, Networking, Virtualization and Cloud business verticals. Calsoft provides End-to-End Product Development, Quality Assurance Sustenance, Solution Engineering and Professional Services expertise to assist customers in achieving their product development and business goals. The company's deep domain knowledge of Storage, Virtualization, Networking and Cloud verticals helps in delivering ...
Oct. 22, 2016 05:30 PM EDT Reads: 967
SYS-CON Events announced today that 910Telecom will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Housed in the classic Denver Gas & Electric Building, 910 15th St., 910Telecom is a carrier-neutral telecom hotel located in the heart of Denver. Adjacent to CenturyLink, AT&T, and Denver Main, 910Telecom offers connectivity to all major carriers, Internet service providers, Internet backbones and ...
Oct. 22, 2016 04:00 PM EDT Reads: 3,582
Extreme Computing is the ability to leverage highly performant infrastructure and software to accelerate Big Data, machine learning, HPC, and Enterprise applications. High IOPS Storage, low-latency networks, in-memory databases, GPUs and other parallel accelerators are being used to achieve faster results and help businesses make better decisions. In his session at 18th Cloud Expo, Michael O'Neill, Strategic Business Development at NVIDIA, focused on some of the unique ways extreme computing is...
Oct. 22, 2016 04:00 PM EDT Reads: 3,843
In his general session at 18th Cloud Expo, Lee Atchison, Principal Cloud Architect and Advocate at New Relic, discussed cloud as a ‘better data center’ and how it adds new capacity (faster) and improves application availability (redundancy). The cloud is a ‘Dynamic Tool for Dynamic Apps’ and resource allocation is an integral part of your application architecture, so use only the resources you need and allocate /de-allocate resources on the fly.
Oct. 22, 2016 04:00 PM EDT Reads: 3,655
In the next five to ten years, millions, if not billions of things will become smarter. This smartness goes beyond connected things in our homes like the fridge, thermostat and fancy lighting, and into heavily regulated industries including aerospace, pharmaceutical/medical devices and energy. “Smartness” will embed itself within individual products that are part of our daily lives. We will engage with smart products - learning from them, informing them, and communicating with them. Smart produc...
Oct. 22, 2016 03:45 PM EDT Reads: 1,441
More and more brands have jumped on the IoT bandwagon. We have an excess of wearables – activity trackers, smartwatches, smart glasses and sneakers, and more that track seemingly endless datapoints. However, most consumers have no idea what “IoT” means. Creating more wearables that track data shouldn't be the aim of brands; delivering meaningful, tangible relevance to their users should be. We're in a period in which the IoT pendulum is still swinging. Initially, it swung toward "smart for smar...
Oct. 22, 2016 03:45 PM EDT Reads: 649
In his keynote at 19th Cloud Expo, Sheng Liang, co-founder and CEO of Rancher Labs, will discuss the technological advances and new business opportunities created by the rapid adoption of containers. With the success of Amazon Web Services (AWS) and various open source technologies used to build private clouds, cloud computing has become an essential component of IT strategy. However, users continue to face challenges in implementing clouds, as older technologies evolve and newer ones like Docke...
Oct. 22, 2016 03:30 PM EDT Reads: 2,244
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.
Oct. 22, 2016 03:00 PM EDT Reads: 3,894
In his session at 19th Cloud Expo, Claude Remillard, Principal Program Manager in Developer Division at Microsoft, will contrast how his team used config as code and immutable patterns for continuous delivery of microservices and apps to the cloud. He will show the immutable patterns helps developers do away with most of the complexity of config as code-enabling scenarios such as rollback, zero downtime upgrades with far greater simplicity. He will also have live demos of building immutable pipe...
Oct. 22, 2016 02:45 PM EDT Reads: 1,501
Rapid innovation, changing business landscapes, and new IT demands force businesses to make changes quickly. In the eyes of many, containers are at the brink of becoming a pervasive technology in enterprise IT to accelerate application delivery. In this presentation, you'll learn about the: The transformation of IT to a DevOps, microservices, and container-based architecture What are containers and how DevOps practices can operate in a container-based environment A demonstration of how Docke...
Oct. 22, 2016 02:45 PM EDT Reads: 1,541