SECAUCUS, N.J., Sept. 26, 2019 /PRNewswire/ -- Dr. Fabien Bitan, Chief of Spine
The surgery will be performed on a former Newark, NJ, public school teacher, who taught for nearly 20 years with a focus on special needs children. Recently retired, she plans to embark on her next career as a drug and alcohol counselor. However, her plans were put on hold due to a traumatic back injury she sustained as a teacher.
Recently approved by the U.S. Food and Drug Administration, the M6-C™ disc was designed as an innovative option for patients needing artificial disc replacement as an alternative to spinal fusion. Featuring a shock-absorbing nucleus and fiber annulus that work together to mimic the anatomic structure of a natural disc, the M6-C™ device is the only artificial cervical disc available in the U.S. that enables compression or "shock absorption" at the implanted level. The disc also provides a controlled range of motion when the spine transitions in its combined complex movements.
"I'm honored to be one of the first spine surgeons in the U.S. to offer this next-generation option to patients with cervical disc pathologies who are candidates for artificial disc replacement," said Dr. Fabien Bitan. "The M6-C™ disc represents the continued evolution of artificial cervical disc technology. It can be a game-changer for those with chronic back pain and immobility due to cervical disc degeneration."
The M6-C™ disc is designed to mimic the spine's natural structure and movement, including backward and forward, side to side, up and down movements, and rotations to the left and right. By allowing the spine to move naturally, the M6-C™ artificial disc potentially minimizes stress to adjacent discs and other vertebral structures.
In February 2019, the M6-C™ disc received U.S. Food and Drug Administration (FDA) approval, which was based on clinical data from a U.S. Investigational Device Exemption (IDE) study that evaluated the safety and effectiveness of the M6-C™ artificial cervical disc compared to anterior cervical discectomy and fusion (ACDF) for the treatment of symptomatic cervical radiculopathy with or without cord compression. Patients in the study who received the M6-C™ disc had a meaningful clinical improvement in pain scores including:
Prior to surgery, 80.6 percent of the M6-C™ disc patients and 85.7 percent of the ACDF patients were taking some type of pain medication for the treatment of their cervical spine condition. At 24 months, the rate of M6-C™ patients who were still taking some type of pain medication dropped to 14.0 percent compared to 38.2 percent of the ACDF patients. Of these, there was a seven times higher rate of opioid use with the ACDF patients than with patients who received the M6-C™ disc.
Additionally, study patients reported a 92 percent satisfaction rate with the M6-C™ disc surgery, and 93 percent said they would have the surgery again.
Prior to U.S. launch, the device had received CE Mark approval for distribution in the European Union and other international geographies. To date, there have been more than 45,000 implants of the M6-C™ artificial cervical disc outside of the U.S.
About Dr. BitanDr. Fabien D. Bitan is an orthopedic surgeon specializing in spine surgery in Manhattan where he is director of Spine Surgery services at Lenox Hill Hospital, proprietor of Manhattan Orthopedic Spine, PLLC, in New York City and consultant at Atlantic Spine Center in New Jersey. Dr. Bitan's clinical field is exclusively spinal surgery, he focuses on non-fusion technologies. He is also a leading clinical researcher in the field of spinal surgery.
As an internationally renowned surgeon and researcher, Dr. Bitan has devoted a large amount of time to teaching and supervising young physicians. As a leading expert in artificial disc replacement, he frequently provides training to surgeons nationally and internationally. Dr. Bitan was the principal investigator for the FDA to import the first artificial disc replacement in the country. Dr. Bitan has advocated and has become a coach for other surgeons to adopt the disc replacements methods.
The M6-C™ artificial cervical disc is manufactured and distributed by Orthofix (Lewisville, TX) a global medical device company focused on musculoskeletal products and therapies.
Dr. Bitan's contact information and offices:
Manhattan Orthopedic Spine:215 East 77th Street, New York, NY 10075Phone: (212) 717-7463
Atlantic Spine Center:475 Prospect Avenue, Suite 110, West Orange, NJ 07052Phone: (973) 419-0200
Media Contact: Amiee Watts, Zito Partners(973) firstname.lastname@example.org
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SOURCE Dr. Fabien D. Bitan