Tele: 561.316.3330
Breaking Medical Device News

Saturday, October 16, 2021
HomeOrthofix Medical Inc.M6-C Artificial Cervical Disc Receives FDA Approval

M6-C Artificial Cervical Disc Receives FDA Approval

M6-C Artificial Cervical Disc Treats Patients with Cervical Disc Degeneration

The M6-C artificial cervical disc for patients suffering from cervical disc degeneration has received U.S. Food and Drug Administration approval.  The M6-C artificial cervical disc was developed by Spinal Kinetics, a company acquired by Orthofix in April 2018.

Orthofix President and Chief Executive Officer, Brad Mason said, “With the approval of the M6-C artificial cervical disc, Orthofix now has the industry’s most comprehensive portfolio of cervical spine products to best serve our surgeon customers and patients. In addition to a full line of anterior, posterior and interbody fusion cervical implants, we offer the CervicalStim device, the only FDA-approved cervical bone growth stimulation therapy, and the Trinity ELITE® allograft, a market-leading allograft developed in partnership with MTF Biologics.”  He added, “The launch of the M6-C artificial cervical disc in the U.S. will complement this existing spine portfolio and represents a significant milestone in the execution of our strategy to accelerate top line growth.”

The M6-C artificial cervical disc is a next-generation artificial disc developed to replace an intervertebral disc damaged by cervical disc degeneration. Designed to restore physiologic motion to the spine, the M6-C disc is indicated as an alternative to cervical fusion. The M6-C artificial cervical disc preserves motion by restoring biomechanical function at the treated level after native disc removal and potentially reduces subsequent degeneration of adjacent vertebral segments. The M6-C device is the only artificial cervical disc that mimics the anatomic structure of a natural disc by incorporating an artificial visco-elastic nucleus and fiber annulus into its design. Like a natural disc, this unique construct allows for shock absorption at the implanted level, as well as provides a controlled range of motion when the spine transitions in its combined complex movements.

Pre-market approval 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 presented with degenerative cervical radiculopathy requiring surgical intervention, and confirmed clinically and radiographically at one vertebral level from C3 to C7.

Study results at 24 months include the following clinical patient outcomes:

  • 90.5 percent of patients who received the M6-C disc demonstrated a meaningful clinical improvement in the Neck Disability Index.
  • A meaningful clinical improvement in arm pain score was seen in 91.2 percent of the M6-C disc patients compared to 77.9 percent in ACDF patients. In addition, this same meaningful improvement was seen in neck pain scores with 90.5 percent of patients who received the M6-C disc compared to 79.9 percent in patients who underwent the ACDF procedure.
  • The M6-C disc preserved range of motion in flexion-extension and lateral bending in the study group.
  • 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, 14.0 percent of the M6-C disc patients were still taking some type of pain medication compared to 38.2 percent of the ACDF patients.
    • Of the patients still taking pain medication there was a seven times higher rate of opioid use with the ACDF patients than with patients who received the M6-C disc.
  • Additional surgery at the treated level was needed in 4.8 percent of the ACDF patients compared to 1.9 percent of the M6-C disc patients.

The prospective, non-randomized, concurrently controlled, multi-center clinical trial was conducted at 23 sites in the United States.

“Cervical disc degeneration is a common condition that can cause pain in the neck, shoulders, arms and hands and lead to numbness and weakness in the arm or hands. Often this condition is the result of a vertebral disc that has deteriorated or been damaged due to the natural aging process or an injury,” said Dr. Rick Sasso, orthopedic spine surgeon, professor and chief of spine surgery at the Indiana University School of Medicine in Indianapolis and an investigator in the M6-C artificial cervical disc IDE study. “For many of these patients, the M6-C artificial cervical disc will give us the ability to replace the patient’s damaged disc with one that closely mimics their natural disc, enabling them to regain motion and return to their normal activities.”

Orthofix expects to release the M6-C artificial cervical disc in 2019 through a controlled, limited market launch in the U.S. accompanied by an extensive training and education curriculum for surgeons. The M6-C artificial cervical disc received CE Mark approval for distribution in the European Union and other international geographies in 2006 and there have been more than 45,000 implants of the M6-C artificial cervical disc outside of the U.S. to date.

 

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

Stay Connected

spot_img

Don't Miss

Ganymed Robotics Awarded a €2.5M Grant from the EC through the EIC Accelerator Program

Ganymed Robotics is developing a radically new approach to surgical robotics by combining computer vision, a branch of artificial intelligence, and mechatronics.

Global Healthcare Exchange Announces Acquisition of Explorer Surgical

Explorer Surgical will operate as a wholly-owned subsidiary of GHX.

Arlington Scientific Broadens Product Portfolio and Further Expands its Product Offering Through the acquisition of Non-Mammalian Blocking Buffers

Arlington Scientific, Inc. (ASI) is pleased to announce that it has acquired the non-mammalian blocking buffer product line from Clark McDermith, former owner of...

Laborie Medical Technologies Acquires Pelvalon

Laborie was represented by Piper Sandler (financial advisor) and Simpson Thacher & Bartlett LLP (legal advisor). Pelvalon was represented by J.P. Morgan Securities LLC (financial advisor) and Dorsey & Whitney LLP (legal advisor).

Herculite Products, Inc. Promotes Two Employees to New Roles

Paul Flaherty Chief Strategy Officer and Marco Angelone is being promoted to the role of Chief Financial Officer.

Prof. Joseph Kvedar Added to the Sweetch Advisory Board Member

Prof. Josdeph Kvedar is the current chair of the board at the American Telemedicine Association (ATA), formerly VP of Connected Health at Mass-Gen Brigham, co-chair of the American Medical Association (AMA) Digital Medicine Payment Advisory Group, and author of The Internet of Healthy Things and The New Mobile Age.

Sid Bala Named President of HealthChampion

Sid Bala is the former president and chief executive officer of alligatortek, a custom software applications company that was acquired by HealthChampion in 2020 where he led them for 27 years after he founded the business

Cochlear Announces FDA Approval and Clearance of first-of-its-kind Remote Care Capabilities for Nucleus and Baha Systems

The FDA approval for the cochlear implant solution and FDA clearance for the Baha solution is the first step in commercializing the product offering, anticipated spring 2022, and complement Cochlear's existing Remote Care offerings.

By using this website you agree to accept Medical Device News Magazine Privacy Policy