NEW YORK–(BUSINESS WIRE)–Paradigm Spine, LLC, a developer of innovative non-fusion and fusion spinal implant solutions, announced today that it has completed patient enrollment in an Investigational Device Exemption (“IDE”) pivotal clinical study comparing the coflex® interlaminar technology to instrumented posterolateral fusion in the surgical treatment of spinal stenosis. Data from this trial will be used to support the coflex® interlaminar technology Pre-Market Approval (“PMA”) application. The study is a prospective, randomized and concurrently controlled clinical study involving more than 380 patients at 21 sites within the United States. The coflex® technology, with over 15 years of clinical heritage outside the U.S., has been implanted in more than 50,000 patients, and is selling in over 40 countries worldwide.
“This is a very exciting time and a significant milestone for Paradigm Spine”
The coflex® technology is a minimally invasive, non-fusion implant that allows movement of the spine in both flexion and extension, while providing interlaminar stabilization, foraminal distraction and facet distraction. The coflex® is a U-shaped titanium alloy surgical device which is implanted in the interlaminar space following a surgical decompression. The coflex® is being evaluated in the United States for use in patients with moderate to severe spinal stenosis, isolated to 1 or 2 levels, in the region of the first to the fifth lumbar vertebrae, specifically L1 to L5.
Dr. Reginald J. Davis, Chief of Neurosurgery at Greater Baltimore Medical Center and an investigator in the study explained, “Since the coflex® device is a functionally dynamic non-fusion implant, it will provide spine surgeons with the option of utilizing a less invasive, tissue sparing procedure while affording patients significant pain relief all without having to resort to fusion. I look forward to having the coflex® device as part of the ‘arsenal’ of surgical options for relief of pain due to spinal stenosis.”
“This is a very exciting time and a significant milestone for Paradigm Spine”, said Marc R. Viscogliosi, Chairman and CEO of Paradigm Spine, LLC. “We are grateful to those patients and their families who have consented to be involved in this clinical study as it represents the first U.S.-based prospective, randomized, multi-center spinal stenosis study comparing a non-fusion interlaminar device to a posterolateral fusion. We are very grateful to our investigators and clinical care teams for their support throughout enrollment and as we continue to follow these patients through the completion of the trial.”
About Lumbar Spinal Stenosis
Lumbar spinal stenosis affects more than 2 million people in the US and millions more worldwide. It is defined as the narrowing of the spinal canal, which may place pressure on the spinal cord or nerves, and occurs mostly in the middle-aged and elderly population. This debilitating disease causes severe back & leg pain which gets worse with time, leaving the patient in a state of constant pain and sometimes immobilization. Currently, the “gold standard” surgical treatment for patients who have lumbar spinal stenosis, in conjunction with minor instability and/or significant back and leg pain, is a surgical decompression of the diseased segment of the spine, followed by pedicle screw fusion. This procedure, although generally successful in alleviating the patient’s leg and back pain, causes significant morbidity and a lengthy recovery time for the patient, in addition to a permanent loss of motion in the fused segment of the spine.
About Paradigm Spine, LLC
Paradigm Spine is a company focused on the design, development and marketing of innovative non-fusion solutions for the treatment of spinal conditions and diseases. The company’s mission is to provide only “Best in Class” products and services to Spine Surgeons and to be above all, “Surgeon Centric, Indication Specific and Data Driven”.
The company is concentrating on building a multi-product non-fusion portfolio. The company’s signature product is the coflex® interlaminar/interspinous functionally dynamic stabilization device, currently being used in over 40 countries. The company is currently conducting an IDE clinical trial of the coflex® implant in the United States.
The FDA cleared the company’s DSS™ system in 2008, which is the company’s first product to be marketed in the United States. Paradigm Spine’s wholly owned subsidiary, Fourth Dimension Spine is developing a portfolio of non-fusion scoliosis implant technologies and a family of predictive diagnostic technologies for scoliosis. In addition to coflex® and DSS™, Paradigm Spine commercially markets two additional spinal implants internationally –DCI™, and coflex-F™
For more information please visit: www.paradigmspine.com