Press release RABEA®
RABEA® – Simple and efficient vertebral body fusion for around 20 years
Alzenau, September 25, 2014. Ever since SIGNUS (Alzenau/Germany) obtained CE marketing approval for the cervical fusion cage RABEA® in 1996, more than 100,000 patients worldwide have been successfully treated with it. RABEA® was the first titanium cage to be approved both in Europe and the USA (after FDA approval was granted in 1999), and it is now in use in more than 40 countries.
For a long time patients with herniated discs had to undergo a treatment procedure that involved extensive and painful harvesting of autologous graft. It was in this context that the idea emerged to fuse two or more vertebral bodies using an implant made from biocompatible material, with the aim of saving the patient from a painful procedure and shortening the operating and treatment time. SIGNUS picked up on the advantages of this method and put them into practice with the market launch of RABEA®, one of the first fusion cages worldwide. The Germany based company, which is celebrating its 20th anniversary this year, thus took an innovative step forward in the treatment of cervical intervertebral disc herniation, and became a pioneer in vertebral body fusion. "Our aim was to develop an efficient concept based on simple surgical principles," says SIGNUS Managing Director, Uwe Siedler. In collaboration with the Department of Neurosurgery at Fulda Hospital/Germany, SIGNUS developed a flat oblong implant with large interior cavities that allow a rich bone growth through the implant, and a patented, toothed surface, which ensures high primary stability.
A comprehensive study program yielded biomechanical and clinical data on the use of RABEA®. Two experimental trials and eleven clinical trials (carried out in collaboration with accredited medical experts and hospitals from Germany, the USA, Korea and Australia) involving almost 1,000 patients produced long-term data and enabled assertions to be made on the suc cessful fusion with RABEA®. As part of this work, Prof. Dr. Tobias Pitzen, Head of the Spinal Surgery unit at Karlsbad Hospital/Germany, led a prospective study on the clinical efficacy of RABEA® PEEK, over a twelve-month observation period: "The implants were filled with local autograft, and bone density was measured in the cage chambers using computed tomography. Findings showed a significant increase in density in the cage after twelve months, and a fusion rate of 91.3%," said Prof. Pitzen.
RABEA® in profile
RABEA® was developed to facilitate interbody fusion in the case of herniated discs (soft and hard), mechanical instability, calcification of the posterior longitudinal ligament, osteochondrosis, and spinal canal stenosis. It is employed following anterior access and discectomy in the cervical region of the spinal column. The implant is available in a variety of sizes and two material options: RABEA® TITAN has proved itself for around 20 years, due to its high level of stability and proven biocompatibility. As a result of the further development of the titanium cage, the implant has also been available in PEEK since 1998 (PEEK-OPTIMA®). This material combines good mechanical properties with additional advantages: It enables artefact-free MR imaging and is also permeable to X-rays, which makes it easy to check fusion postoperatively. Integrated titanium markers also help to verify the position of the PEEK cage.
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