SOURCE: Spinal Kinetics
March 22, 2011 09:00 ET
Spinal Kinetics Completes 10,000th Implant of M6® Artificial Spinal Disc
Advanced Artificial Disc Technology Mimics Natural Spinal Disc
SUNNYVALE, CA--(Marketwire - March 22, 2011) - Spinal Kinetics, a leading innovator of advanced artificial disc technology, today announced that it has successfully completed the 10,000th implant of its M6 Artificial Spinal Disc. The M6-C cervical and M6-L lumbar artificial discs help patients suffering from degenerative disc disease of the spine; a common cause of chronic and severe back and neck pain. The M6 technology provides an alternative to spinal fusion and is designed to preserve motion and reduce the chances of subsequent degeneration of adjacent discs. Introduced internationally in 2007, M6 has quickly become a market leader in Europe and is available in over 15 countries worldwide.
"We are very excited about reaching the 10,000th implant mark so soon after introducing the M6 discs internationally," states Tom Afzal, Spinal Kinetics President and CEO. "The enthusiastic reception from both the spinal surgeon community and patients who have received the M6 disc has been extremely gratifying for the entire organization. We look forward to making the M6 technology available to more patients in more countries as we continue our international expansion and the next phase of our US clinical trials."
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. In the US, Spinal Kinetics has successfully completed an FDA IDE Pilot Study of the M6-C in patients with both single and two level disease, and has received approval from the FDA to initiate an IDE Pivotal Study.
"Motion preservation with the M6 disc is a very exciting advance for spine surgery technology," states Carl Lauryssen, MD, Chief of Spine Surgery at Olympia Medical Center in Beverly Hills. "We have seen extremely high success rates with our patients from the FDA Pilot Study, and believe the technology is increasing the quality of life for patients with degenerative disc disease beyond what was previously available to them."
"After doing extensive research, I traveled to the UK to get my M6 implants because I knew the technology was the most advanced and promising for disc replacement," states Marti Conger, a business consultant from California who travelled to Europe in 2009 for treatment. "My surgery went smoothly and my neck has been pain-free for more than two years. I'm hopeful that this technology will be made available in the US for other patients like me."
About Degenerative Disc Disease
Between each 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 each vertebra. Degenerative disc disease is a condition caused by the breakdown of the intervertebral discs. Often brought on by age, the spine begins to show signs of wear and tear as the discs dry out and shrink. These age-related changes can put pressure on the spinal cord and nerves and may cause back pain and other spinal 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 partnering with spine surgeons to develop innovative and practical motion preservation systems for treating degenerative diseases of the spine. Launched in Europe in 2007 and 2010 respectively, 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 mimic natural discs. The company is located in Sunnyvale, California.
For more information on Spinal Kinetics or the M6 Artificial Disc, please visit www.spinalkinetics.com