Healthcare Industry News: bone graft
News Release - October 19, 2007
Cervitech Announces Completion of Patient Enrollment Phase in Pivotal U.S. Clinical Trial of PCM(R) Artificial Cervical DiscRandomized FDA Study Assesses the Safety and Efficacy of PCM(R) Artificial Cervical Disc for the Treatment of Degenerative Disc Disease and Herniated Disc
ROCKAWAY, N.J.--(HSMN NewsFeed)--Cervitech, Inc. announced today the completion of patient enrollment in the PCM® Artificial Cervical Disc study. The data attained from the patients enrolled in the multi-center study may support approval of an alternative to cervical spine fusion for patients suffering from degenerative disc disease and herniated discs. The information gathered from this clinical trial will fuel an application to the FDA for the approval and future commercial sale of the device in the United States.
The PCM (Porous Coated Motion) Artificial Cervical Disc was designed by leading spine surgeons, and in collaboration with Waldemar Link GmbH&Co, a German orthopedic implant company with extensive experience in artificial joint replacement. The PCM provides spine surgeons with an implant designed to retain motion following the removal of the injured or diseased disc. The implant itself is manufactured out of cobalt chrome alloy and ultra high molecular weight polyethylene (UHMWPE), the same materials which are used in artificial hip and knee replacements. The PCM is implanted into the disc space between the bones in the neck, and the gliding interface between the upper and lower implant components allow motion between the adjacent vertebrae as the neck bends and twists.
“This is an important milestone for us,” commented Helmut Link, Founder and President of Cervitech. “After bringing the first spinal disc replacement to the US almost ten years ago, I am proud to be pursuing cervical motion retention technology in the US as well. We are very grateful to the many dedicated clinical investigators and their research teams, and of course, the patients, for their participation and efforts in the study. We are hopeful that their work will ultimately result in approval by the FDA.”
As many as 200,000 patients in the United States receive surgical treatment annually for cervical (neck region) discs that are either injured or degenerated, and causing pain by compressing or “pinching” the adjacent nerves. Currently, most patients receive a surgical procedure using bone grafts and securing plates to ‘fuse’ the adjacent cervical vertebrae together. Artificial cervical discs, like the PCM, are designed to provide the stability needed following disc removal, but still allow the adjacent vertebrae to move.
“Cervical artificial disc technology is a valuable addition to our armamentarium for treating neck injuries and disorders,” explained Paul McAfee, M.D., orthopedic surgeon from Towson, MD and the lead investigator of the study. “The PCM represents the latest technology in the field, and it’s great that it’s one step closer to approval.
“Conducting studies like these involves a significant amount of work for all,” added Andrew Cappuccino, M.D., an orthopedic surgeon from Buffalo, NY, “But they really yield a tremendous amount of valuable information about these new technologies.”
Since its global introduction in 2004, more than 5000 surgical implantations of the PCM Artificial Cervical Disc have been performed in over 25 countries. In the United States, follow up in the PCM study will continue for two years post-treatment prior to FDA review and possible approval for general clinical use. Last month the FDA approved the first artificial cervical disc for commercial sale in the US, the Prestige ST Cervical Disc by Medtronic. Further disc designs by Medtronic, Synthes, Stryker, Johnson and Johnson, and others are in various stages of clinical study in the US.
Cervitech, Inc. (www.cervitech.com) is a privately held medical device company headquartered in Rockaway, NJ focused on becoming the leader in the development of motion-preserving technologies for the treatment of cervical spinal disorders. Founded by Helmut Link, of Waldemar Link GmbH & Co., a pioneer for decades in artificial joint technologies, the company combines state of the art German manufacturing and product development with both UK and US bases of operations.
Cervitech continues to develop a comprehensive system of cervical disc replacement implants manufactured from alternative materials and configured to address varying anatomic situations. A proprietary ceramic on ceramic design is one such version under development. Additional US Clinical Trials are expected to begin shortly on these additional versions.
Cervitech and PCM are registered trademarks of Cervitech, Inc.
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