Click here to close now.




















Welcome!

News Feed Item

Spinal Kinetics and Dr. Kenneth Pettine Initiate US FDA Clinical Trial of M6(R)-C Artificial Cervical Disc at Arete Surgery Center

SUNNYVALE, CA and JOHNSTOWN, CO -- (Marketwired) -- 06/11/14 -- Spinal Kinetics, the designer and manufacturer of the M6® Artificial Disc, and Kenneth A. Pettine, MD, a leading spine surgeon in northern Colorado, announced completion of the initial series of M6-C implants as part of a US FDA Clinical Trial at Arête Surgical Center in Johnstown, Colorado. To date, four patients have received the innovative artificial disc at Arête and are among the first treated nationwide.

Dr. Pettine is the only surgeon in Colorado enrolling for the FDA trial and one of only a select number of centers in the US. The trial compares single-level cervical disc replacement to single-level cervical fusion. The M6-C artificial disc represents next generation technology in artificial cervical disc design. "We are very excited to participate in this important clinical trial," said Dr. Kenneth Pettine, M6-C Clinical Trial Investigator and co-Founder of Arête Surgical Center and The Spine Institute at Rocky Mountain Associates in Orthopedic Medicine (Johnstown, CO). "The M6-C has established a phenomenal track record overseas, and we are happy to finally bring this advancement to our patient base here in the US for this clinical study."

The M6-C artificial cervical disc is designed to help patients suffering from degenerative disc disease of the spine, a common cause of chronic neck and arm pain. The M6 technology provides an alternative to spinal fusion and is designed to restore natural physiologic motion to the spine. The M6 is the only artificial disc that replicates the anatomic structure and biomechanics of a natural disc by incorporating both an artificial nucleus and annulus.

"Spinal Kinetics is proud to collaborate with Dr. Kenneth Pettine at the Spine Institute and the team at Arête Surgical Center on this important milestone event," said Tom Afzal, President and CEO of Spinal Kinetics, Inc. "Spine surgeons and patients across the US have asked for access to this leading edge disc technology, and we are excited to start the process toward FDA approval by working with key Surgeon/Investigators like Dr. Pettine and innovative Spine Centers like Arête."

Introduced internationally in 2006, M6 technology has quickly become the market leader in Europe and other international markets and is available in over 27 countries worldwide. With approximately 30,000 implants to date, the M6 has become the disc of choice among leading spine surgeons around the world. In the U.S., Spinal Kinetics has successfully completed an FDA approved pilot study of the M6-C and subsequently received approval from the FDA to initiate the current clinical trial.

For more information on potential enrollment in the M6-C Clinical Trial, please contact Kira Sniff at [email protected], or (970) 669-8881 ext 229.

About Degenerative Disc Disease
Between adjacent vertebra throughout the spine is an intervertebral disc; a shock-absorbing pillow that helps maintain proper spacing, stability, and motion within the spine. Each disc has a fibrous outer band called the annulus fibrosus that encases a central, gel-like substance called the nucleus pulposus. The nucleus and annulus work together to absorb shock, help stabilize the spine, and provide a controlled range of motion between adjacent vertebra. Often brought on by aging, the spine begins to show signs of wear and tear and the discs can dry out and shrink. This degenerative process can put pressure on the spinal cord and nerves and may cause neck, arm and back pain and other painful conditions such as spinal stenosis or a herniated disc.

About Spinal Kinetics
Founded in 2003, Spinal Kinetics is a privately held medical device company focused on developing innovative and practical solutions for treatment of diseases of the spine. The M6-C cervical and M6-L lumbar artificial discs have rapidly established themselves among the leading artificial discs available due to their unique biomechanical properties that replicate the motion of a natural disc. The company is located in Sunnyvale, California.

About Kenneth A. Pettine, MD
Dr. Kenneth Pettine co-founded The Spine Institute at Rocky Mountain Associates in Orthopedic Medicine. He has an extensive background in spinal surgery, research, and rehabilitation. Dr. Pettine is a board certified fellowship trained spine surgeon. He is the recipient of numerous honors, a distinguished speaker at national and international symposiums, and the author of nearly 20 research publications. He has been the principal investigator for 16 FDA studies involving non-fusion implants, biologics, and stem cells. For information on Dr. Pettine and The Spine Institute visit www.spinerevolution.com

About Arête Surgical Center
Arête is a pain management and orthopedic/ spine ambulatory surgical facility in Johnstown, CO, that is licensed and joint commission accredited. We provide our patients with quality outpatient and inpatient surgical care in a safe and friendly environment. For information on the Arête Surgical Center, please visit www.aretesurgicalcenter.com

For more information on Spinal Kinetics, the M6 Artificial Disc and the M6-C Clinical Trial, please visit www.spinalkinetics.com.

For Spinal Kinetics Investor Relations, contact:
Gary Paul
Email Contact
408-636-2540

More Stories By Marketwired .

Copyright © 2009 Marketwired. All rights reserved. All the news releases provided by Marketwired are copyrighted. Any forms of copying other than an individual user's personal reference without express written permission is prohibited. Further distribution of these materials is strictly forbidden, including but not limited to, posting, emailing, faxing, archiving in a public database, redistributing via a computer network or in a printed form.

Latest Stories
The Internet of Things is in the early stages of mainstream deployment but it promises to unlock value and rapidly transform how organizations manage, operationalize, and monetize their assets. IoT is a complex structure of hardware, sensors, applications, analytics and devices that need to be able to communicate geographically and across all functions. Once the data is collected from numerous endpoints, the challenge then becomes converting it into actionable insight.
With the proliferation of connected devices underpinning new Internet of Things systems, Brandon Schulz, Director of Luxoft IoT – Retail, will be looking at the transformation of the retail customer experience in brick and mortar stores in his session at @ThingsExpo. Questions he will address include: Will beacons drop to the wayside like QR codes, or be a proximity-based profit driver? How will the customer experience change in stores of all types when everything can be instrumented and a...
Enterprises can achieve rigorous IT security as well as improved DevOps practices and Cloud economics by taking a new, cloud-native approach to application delivery. Because the attack surface for cloud applications is dramatically different than for highly controlled data centers, a disciplined and multi-layered approach that spans all of your processes, staff, vendors and technologies is required. This may sound expensive and time consuming to achieve as you plan how to move selected applicati...
SYS-CON Events announced today that HPM Networks will exhibit at the 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. For 20 years, HPM Networks has been integrating technology solutions that solve complex business challenges. HPM Networks has designed solutions for both SMB and enterprise customers throughout the San Francisco Bay Area.
This Enterprise Strategy Group lab validation report of the NEC Express5800/R320 server with Intel® Xeon® processor presents the benefits of 99.999% uptime NEC fault-tolerant servers that lower overall virtualized server total cost of ownership. This report also includes survey data on the significant costs associated with system outages impacting enterprise and web applications. Click Here to Download Report Now!
Consumer IoT applications provide data about the user that just doesn’t exist in traditional PC or mobile web applications. This rich data, or “context,” enables the highly personalized consumer experiences that characterize many consumer IoT apps. This same data is also providing brands with unprecedented insight into how their connected products are being used, while, at the same time, powering highly targeted engagement and marketing opportunities. In his session at @ThingsExpo, Nathan Trel...
Whether you like it or not, DevOps is on track for a remarkable alliance with security. The SEC didn’t approve the merger. And your boss hasn’t heard anything about it. Yet, this unruly triumvirate will soon dominate and deliver DevSecOps faster, cheaper, better, and on an unprecedented scale. In his session at DevOps Summit, Frank Bunger, VP of Customer Success at ScriptRock, will discuss how this cathartic moment will propel the DevOps movement from such stuff as dreams are made on to a prac...
In 2014, the market witnessed a massive migration to the cloud as enterprises finally overcame their fears of the cloud’s viability, security, etc. Over the past 18 months, AWS, Google and Microsoft have waged an ongoing battle through a wave of price cuts and new features. For IT executives, sorting through all the noise to make the best cloud investment decisions has become daunting. Enterprises can and are moving away from a "one size fits all" cloud approach. The new competitive field has ...
Through WebRTC, audio and video communications are being embedded more easily than ever into applications, helping carriers, enterprises and independent software vendors deliver greater functionality to their end users. With today’s business world increasingly focused on outcomes, users’ growing calls for ease of use, and businesses craving smarter, tighter integration, what’s the next step in delivering a richer, more immersive experience? That richer, more fully integrated experience comes ab...
SYS-CON Events announced today that Pythian, a global IT services company specializing in helping companies leverage disruptive technologies to optimize revenue-generating systems, has been named “Bronze Sponsor” of SYS-CON's 17th Cloud Expo, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Founded in 1997, Pythian is a global IT services company that helps companies compete by adopting disruptive technologies such as cloud, Big Data, advance...
Organizations from small to large are increasingly adopting cloud solutions to deliver essential business services at a much lower cost. According to cyber security experts, the frequency and severity of cyber-attacks are on the rise, causing alarm to businesses and customers across a variety of industries. To defend against exploits like these, a company must adopt a comprehensive security defense strategy that is designed for their business. In 2015, organizations such as United Airlines, Sony...
Culture is the most important ingredient of DevOps. The challenge for most organizations is defining and communicating a vision of beneficial DevOps culture for their organizations, and then facilitating the changes needed to achieve that. Often this comes down to an ability to provide true leadership. As a CIO, are your direct reports IT managers or are they IT leaders? The hard truth is that many IT managers have risen through the ranks based on their technical skills, not their leadership ab...
eCube Systems has released NXTmonitor, a full featured application orchestration solution. NXTmonitor, which inherited the code base of NXTminder, has been extended to support multi-discipline processes and will act as a DevOps utility in a heterogeneous enterprise environment. Previously, NXTminder was packaged with NXTera middleware to configure and manage Entera and NXTera RPC servers. “Since we are widening the focus of this solution to DevOps, we felt the need to change the name to NXTmon...
As more and more data is generated from a variety of connected devices, the need to get insights from this data and predict future behavior and trends is increasingly essential for businesses. Real-time stream processing is needed in a variety of different industries such as Manufacturing, Oil and Gas, Automobile, Finance, Online Retail, Smart Grids, and Healthcare. Azure Stream Analytics is a fully managed distributed stream computation service that provides low latency, scalable processing of ...
In today's digital world, change is the one constant. Disruptive innovations like cloud, mobility, social media, and the Internet of Things have reshaped the market and set new standards in customer expectations. To remain competitive, businesses must tap the potential of emerging technologies and markets through the rapid release of new products and services. However, the rigid and siloed structures of traditional IT platforms and processes are slowing them down – resulting in lengthy delivery ...