NEW YORK, NY. – March 29, 2010 - 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.
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
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.
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
-
Press -
29.03.2010
PARADIGM SPINE
COMPLETES ENROLLMENT
IN PIVOTAL CLINICAL
STUDY OF COFLEX®
INTERLAMINAR TECHNOLOGY
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