Spinal Kinetics Completes First Patient Implant In Initial U.S. Clinical Trial

Main Category: Neurology / Neuroscience
Also Included In: Clinical Trials / Drug Trials;  Medical Devices
Article Date: 06 Mar 2008 - 4:00 PDT

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Spinal Kinetics, a leader and innovator in advanced generation artificial disc technology, announced that it has enrolled the first U.S. Feasibility Study patient and successfully implanted the company's M6-C artificial cervical disc. This first procedure was completed at Olympia Medical Center in Beverly Hills, California by leading spine surgeon Carl Lauryssen, M.D., from the Institute for Advanced Spinal Research. Last December the company received approval from the U.S. Food and Drug Administration (FDA) to initiate a study evaluating the M6-C artificial cervical disc with patients suffering from degenerative disc disease of the cervical spine; a common cause of neck and arm pain.

The M6 artificial disc represents the company's first non-fusion, motion preservation products to treat degenerative diseases of the spine. The M6 is an advanced generation artificial disc developed to replace an intervertebral disc damaged by cervical disc degeneration. It is the only artificial disc that replicates the anatomic structure of a natural disc by incorporating an artificial nucleus and annulus. Together, the artificial nucleus and annulus are designed to provide the same motion characteristics of a natural disc.

The M6's compressible polymer nucleus is designed to simulate the function of the native nucleus, while the surrounding multi-layer high tensile strength fiber annulus is intended to facilitate a controlled range of motion in multiple directions. The M6 artificial disc is implanted with proprietary surgical instrumentation. This specialized system was designed with surgeon feedback and is intended for simple, safe, and reproducible M6 implantation.

"We are extremely pleased with our recent FDA approval to move forward with the M6 feasibility trial, as well as completion of our first U.S. implantation by Dr. Lauryssen and his team at Olympia," says Tom Afzal, Spinal Kinetics President and CEO. "The M6 artificial cervical disc represents our initial commitment as an organization to provide both physicians and patients alike the most innovative motion preservation technologies for treating degenerative diseases of the spine."

Artificial disc technology provides an alternative to spinal fusion in the treatment of degenerative disc disease. Preserving motion with an artificial disc provides an opportunity to restore biomechanical function at the treated level after disc removal, as well as the possibility to reduce subsequent degeneration of adjacent segments.

"The M6 artificial disc represents the latest advancement in artificial disc technology with its unique structural and performance characteristics and its ease of use," states Carl Lauryssen, M.D., Chief of Spine Surgery at Olympia Medical Center in Beverly Hills, California. "As a physician, I am excited that this technology is now clinically available to patients, allowing us to conduct a strict and regimented study to prove the M6's clinical benefits."

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. The company is located in Sunnyvale, California.

Spinal Kinetics