|By Marketwired .||
|June 11, 2014 11:00 PM EDT||
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: