Logo courtesy of Laser Spine Institute, Spinal Kinetics and Titan Spine

Laser Spine Institute has announced that it will partner with two companies for two upcoming clinical trials: Spinal Kinetics and Titan Spine. Patients will be enrolled at Laser Spine Institute’s ambulatory surgery center (ASC) in Tampa, Florida.

According to the news release, “In an FDA-regulated clinical trial studying the M6-C artificial cervical disc, considered by some to be the most advanced technology in motion preservation, Laser Spine Institute will partner with Spinal Kinetics by enrolling patients in the anterior cervical discectomy and fusion (ACDF) control group arm of the trial…”

“The clinical trials with Titan Spine will involve transforaminal lumbar interbody fusion procedures for up to 25 clinical trial patients. The procedure fuses the anterior and posterior columns of the spine through a posterior approach…”

Laser Spine Institute President David Pillsbury, told OTW, “Whether it’s through the introduction of new technology, or just simple improvements in our processes, we hope to be stewards of change with our clinical trials. While our patients will continue to receive our current standard of care, we’re hoping to make a big impact—particularly in pain levels and disability outcomes—in the least invasive way possible.”

John Rosich, National Sales Director-Target Accounts for Titan Spine, told OTW, “Titan Spine has enjoyed a long standing relationship with Laser Spine Institute’s newly appointed Director of Clinical Research, Dr. Reggie Davis, due to his interest in Titan’s proprietary surface technology and the potential benefits it has for his patients. Dr. Davis is the principal investigator for Titan’s TLIF study and became the main conduit between Titan Spine and Laser Spine Institute when he joined their staff several months ago. We are pleased to have Laser Spine Institute as one of the research sites for our clinical study.”

Neal Defibaugh, Vice President of Clinical and Regulatory Affairs, Spinal Kinetics, told OTW, “Laser Spine Institute was selected to participate in our M6-C artificial cervical disc Pivotal Trial as a result of two very important factors. The first is Laser Spine Institute’s recent appointment of Dr. Reginald Davis as Director of Clinical Research for the organization’s strategic clinical trial platform. Dr. Davis’ leadership and experience in clinical research is well known and respected throughout the spinal community and regulatory bodies. The opportunity to have Dr. Davis involved as one of our principal investigators continues our strong commitment to having highly respected physicians and their teams involved in proving the safety and efficacy of the M6-C artificial cervical disc.”

“The second reason for selecting Laser Spine Institute as a study center is its clinical research infrastructure and commitment to pioneering the advancement of new technologies for minimally invasive spinal surgery. As it is for Spinal Kinetics, the focus and priority for Laser Spine Institute is the patient. Providing the most innovative technology and outcomes for the patient is a shared core value. We believe the M6 disc is a technology that will help improve a cervical arthroplasty patient’s quality of life. Spinal Kinetics is very pleased to have Laser Spine Institute as a partner with us in bringing this technology to market.”

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1 Comment

  1. Good morning,

    I have two herniated C5-C6-C7 and I would like to receive information about post operative on the recovery of patients who applied the M6-C prosthesis. This prosthesis is really new in the market and I have trouble finding results on the success of this prosthesis.

    Tks
    Marcelo.

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