NEW YORK, Aug. 1, 2019 /PRNewswire/ -- Dr. Fabien Bitan, Chief of Spine Surgery at Lenox Hill Hospital, a leading clinical researcher in the field of spinal arthroplasty will perform the implantation of the M6-C™ artificial cervical disc on Friday, August 2nd, 2019. The 29-year-old female patient is suffering from a post-traumatic cervical disc herniation. She was the victim of a severe car accident (represented by the law firm Chopra and Nocerino). This surgery will be one of only four performed in the U.S. to date and the first on the East Coast.
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. Bitan. "The M6-C™ disc represents the continued evolution of artificial cervical disc technology."
"Since my accident, I have had to cope with extreme pain. It takes a toll on me physically and emotionally. I am missing out on so much in life right now. That's why I am so excited about this surgical breakthrough. I hope it will give me a better quality of life. If it helps me, it offers hope for so many others like myself who have been sidelined with chronic pain and live with severe mobility challenges," said Joanna Lopez, Dr. Bitan's first patient to undergo the spinal surgery.
"After consulting with several doctors who could not give me any real solutions, Dr. Bitan is the first doctor to make me feel comfortable and give me hope. He took the time to consider my age and presented me with an opportunity that could be a game changer. I really hope this procedure will change my life for the better," Lopez added.
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:
- 91.2 percent of patients who received the M6-C™ disc reported an improvement in neck pain compared to 77.9 percent in patients who underwent the ACDF procedure.
- 90.5 percent of the M6-C™ patients reported improvement in arm pain scores compared to 79.9 percent in ACDF patients.
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. Bitan
Dr. 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.
Manhattan Orthopedic Spine, PLLC
Tel: 212 717-7463
Atlantic Spine Center
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. www.M6disc.com.
SOURCE Dr. Fabien D. Bitan