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Saturday, 21st October 2017

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LRMC to trial new spinal surgery system

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Lakeway Regional Medical Center and Carl Lauryssen MD, a leading spine surgeon with NeuroTexas, today announced the initiation of Lakeway Regional Medical Center as an IDE Clinical Study site for the CarboClear Pedicle Screw System. Dr. Lauryssen is Principal Investigator of the study at Lakeway Regional Medical Center, which will enroll up to15 of the total 55 patients study-wide. The study will take place over the next 36 months. Lakeway Regional Medical Center is one of only a select number of centers worldwide. 

 

 

The CarboClear Pedicle Screw System is intended to provide rigid immobilization and stabilization of lumbar and/or sacral segments as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level from L2 to S1, with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients must be skeletally mature and have at least six months of non-operative treatment.

 

“We are very excited to participate in this important clinical trial”, said Dr. Carl Lauryssen.  “The CarboClear System was first developed in Israel and provides a revolutionary treatment alternative to metal pedicle screws. Accurate CT and MRI images are vitally important in the treatment of disc disease. However, when traditional metal spinal implants are present, the implants can cause artifact on the images. We are pleased to bring this advanced technology to our patient base here in the U.S. as part of this clinical study.”  

 

The CarboClear System is composed of pedicle screws, rods and locking elements. During the operation, two pedicle screws are inserted into each treated vertebra via the vertebral pedicles, in a posterior-anterior orientation (from the back). The screws at each side of the vertebrae are longitudinally (i.e. – along the spine) connected by a rod. Locking elements are placed at each screw-rod intersection, to firmly secure the screws and rods together.

 

The design and dimensions of these investigational pedicle screws and rods are similar to those of other, FDA cleared screws. The main difference is the materials (traditional systems are typically made of metal – stainless steel or titanium) and do not allow for visualization under MRI or CT imaging. The implants being investigated are made of carbon fiber-reinforced polymer and are marked with radiopaque markers to provide for visualization under imaging.  Further, polyaxial pedicle screws allow positioning in a variety of angles (20-40 degrees, depending on screw size). The screws are also made of carbon fiber-reinforced polymer, and their threaded portion is encased with a thin titanium shell – again allowing for visualization under imaging.

 

“CarboFix Orthopedics is proud to collaborate with Dr. Lauryssen and Lakeway Regional Medical Center on this important study,” said Dr. Motti Beyar, Founder and CEO of CarboFix Orthopedics. “We are evaluating leading edge disc technology, and we are excited to continue the process toward FDA approval by working with key Investigators like Dr. Lauryssen and innovative Spine Centers like Lakeway Regional Medical Center.”        

 

 

For more information on enrollment in the CarboClear clinical trial, please contact Kara Krauskopf at This email address is being protected from spambots. You need JavaScript enabled to view it. .

 

About Degenerative Disc Disease

Between adjacent vertebra throughout the spine is an intervertebral disc; a shock-absorbing pillow that helps maintain proper spacing, stability, and motion within the spine.  Each disc has a fibrous outer band called the annulus fibrosus that encases a central, gel-like substance called the nucleus pulposus,  The nucleus and annulus work together to absorb shock, help stabilize the spine, and provide a controlled range of motion between adjacent vertebra.  Often brought on by aging, the spine begins to show signs of wear and tear and the discs can dry out and shrink.  This degenerative process can put pressure on the spinal cord and nerves and may cause neck, arm and back pain and other painful conditions such as spinal stenosis or a herniated disc. 

 

About Carl Lauryssen, MD

Dr. Carl Lauryssen is a spine surgeon at NeuroTexas in Austin, Texas. He was previously the co-director of spine research and development at Olympia Medical Center. He was the first neurosurgeon to inject stem cells into a human spinal cord, as part of an FDA trial. He has also won the American Association of Neurological Surgeons' Young Investigator Award twice for his work on cervical disorders and stem cell research. He previously directed the advanced neurosurgical spine program at Barnes-Jewish Hospital in St. Louis. He completed a spinal neurosurgical fellowship at the University of Alabama at Birmingham School of Medicine.

 

About Lakeway Regional Medical Center

Lakeway Regional Medical Center (LRMC) is a state-of-the-art medical campus dedicated to the delivery of world-class healthcare.  LRMC provides services in emergency medicine, neurosurgery, orthopedics, neurology, cardiology, general surgery, gastroenterology, women’s health. For more information about LRMC, visit lakewayregional.com or call 512-571-5000.

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