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
Identity is in everything and customers are looking to their providers to ensure the security of their identities, transactions and data. With the increased reliance on cloud-based services, service providers must build security and trust into their offerings, adding value to customers and improving the user experience. Making identity, security and privacy easy for customers provides a unique advantage over the competition.
SYS-CON Events announced today that Venafi, the Immune System for the Internet™ and the leading provider of Next Generation Trust Protection, will exhibit at @DevOpsSummit at 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Venafi is the Immune System for the Internet™ that protects the foundation of all cybersecurity – cryptographic keys and digital certificates – so they can’t be misused by bad guys in attacks...
Whether your IoT service is connecting cars, homes, appliances, wearable, cameras or other devices, one question hangs in the balance – how do you actually make money from this service? The ability to turn your IoT service into profit requires the ability to create a monetization strategy that is flexible, scalable and working for you in real-time. It must be a transparent, smoothly implemented strategy that all stakeholders – from customers to the board – will be able to understand and comprehe...
"There's a growing demand from users for things to be faster. When you think about all the transactions or interactions users will have with your product and everything that is between those transactions and interactions - what drives us at Catchpoint Systems is the idea to measure that and to analyze it," explained Leo Vasiliou, Director of Web Performance Engineering at Catchpoint Systems, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York Ci...
"Tintri was started in 2008 with the express purpose of building a storage appliance that is ideal for virtualized environments. We support a lot of different hypervisor platforms from VMware to OpenStack to Hyper-V," explained Dan Florea, Director of Product Management at Tintri, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
"Avere Systems is a hybrid cloud solution provider. We have customers that want to use cloud storage and we have customers that want to take advantage of cloud compute," explained Rebecca Thompson, VP of Marketing at Avere Systems, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
SaaS companies can greatly expand revenue potential by pushing beyond their own borders. The challenge is how to do this without degrading service quality. In his session at 18th Cloud Expo, Adam Rogers, Managing Director at Anexia, discussed how IaaS providers with a global presence and both virtual and dedicated infrastructure can help companies expand their service footprint with low “go-to-market” costs.
For basic one-to-one voice or video calling solutions, WebRTC has proven to be a very powerful technology. Although WebRTC’s core functionality is to provide secure, real-time p2p media streaming, leveraging native platform features and server-side components brings up new communication capabilities for web and native mobile applications, allowing for advanced multi-user use cases such as video broadcasting, conferencing, and media recording.
IoT generates lots of temporal data. But how do you unlock its value? You need to discover patterns that are repeatable in vast quantities of data, understand their meaning, and implement scalable monitoring across multiple data streams in order to monetize the discoveries and insights. Motif discovery and deep learning platforms are emerging to visualize sensor data, to search for patterns and to build application that can monitor real time streams efficiently. In his session at @ThingsExpo, ...
Ovum, a leading technology analyst firm, has published an in-depth report, Ovum Decision Matrix: Selecting a DevOps Release Management Solution, 2016–17. The report focuses on the automation aspects of DevOps, Release Management and compares solutions from the leading vendors.
"This week we're really focusing on scalability, asset preservation and how do you back up to the cloud and in the cloud with object storage, which is really a new way of attacking dealing with your file, your blocked data, where you put it and how you access it," stated Jeff Greenwald, Senior Director of Market Development at HGST, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
When it comes to cloud computing, the ability to turn massive amounts of compute cores on and off on demand sounds attractive to IT staff, who need to manage peaks and valleys in user activity. With cloud bursting, the majority of the data can stay on premises while tapping into compute from public cloud providers, reducing risk and minimizing need to move large files. In his session at 18th Cloud Expo, Scott Jeschonek, Director of Product Management at Avere Systems, discussed the IT and busin...
There will be new vendors providing applications, middleware, and connected devices to support the thriving IoT ecosystem. This essentially means that electronic device manufacturers will also be in the software business. Many will be new to building embedded software or robust software. This creates an increased importance on software quality, particularly within the Industrial Internet of Things where business-critical applications are becoming dependent on products controlled by software. Qua...
Continuous testing helps bridge the gap between developing quickly and maintaining high quality products. But to implement continuous testing, CTOs must take a strategic approach to building a testing infrastructure and toolset that empowers their team to move fast. Download our guide to laying the groundwork for a scalable continuous testing strategy.
As companies gain momentum, the need to maintain high quality products can outstrip their development team’s bandwidth for QA. Building out a large QA team (whether in-house or outsourced) can slow down development and significantly increases costs. This eBook takes QA profiles from 5 companies who successfully scaled up production without building a large QA team and includes: What to consider when choosing CI/CD tools How culture and communication can make or break implementation