Kenneth Pettine, MD, recently completed the first series of M6-C implants as part of the U.S. FDA clinical trial at Arete Surgical Center in Johnstown, Colo.
Here are five things to know about the clinical trial:
1. The trial compares single-level cervical disc replacement to single-level fusion. The M6-C artificial disc represents the next generation technology in cervical disc design. The company successfully completed an FDA-approved pilot study of M6-C and subsequently received approval for initiating the clinical trial.
2. The M6-C artificial disc is the only artificial disc that replicates anatomic structures and biomechanics of a natural disc by incorporating both an artificial nucleus and annulus, according to a company news release.
In all, the clinical trial will include 243 subjects — 162 M6 device subjects from up to 15 clinical sites as well as 81 anterior cervical discectomy and fusion subjects at up to five clinical sites. "Surgeons, patients and our investors have been extremely supportive of the M6 and have enabled us to take this critical step. We look forward to working with the U.S. sites to complete the clinical trial while continuing to expand M6 availability internationally," said Tom Afzal, president and CEO of Spinal Kinetics in a news release.
3. The technology was introduced internationally in 2006 and became a market leader in Europe. The technology is now in 27 countries and has approximately 30,000 implants to date. "We are very excited to participate in this clinical trial," said Dr. Pettine in the news release. "The M6-C has established a phenomenal track record overseas, and we are happy to finally bring this advancement to our patient base here in the [United States] for this clinical study."
4. Spinal Kinetics completed a $34 million private financing round earlier this month. The United States nonfusion and diagnostic devices market which is expected to reach $1.1 billion by 2017, according to a new report from Global Information. The largest segment of this market is minimally invasive discectomy devices, which accounted for approximately 46.5 percent of sales in 2012.
5. There will be up to 15 clinical sites for the M6-C procedure, and Arete Surgical Center is one of them. Arete Surgical Center is an outpatient spinal facility with three operating rooms and six private overnight rooms. The 15,000-square-foot facility was built in 2013 and became a clinical trial site.
"Spinal Kinetics is proud to collaborate with Dr. Kenneth Pettine at the Spine Institute and the team at Arete Surgical Center on this important milestone," said Mr. Afzal. "Spine surgeons and patients across the [United States] have asked for access to this leading edge disc technology and we are excited to start the process toward FDA approval by working with key surgeon/investigators like Dr. Pettine and innovative spine centers like Arete."
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