Healthcare Industry News: Interbody Fusion
News Release - October 13, 2007
Coligne Introduces the First Carbon Composite Spinal Rod
The strength of titanium, flexibility of bone and fatigue performance of compositeZurich, Oct 12 2007--(HSMN NewsFeed)--Coligne AG announces the introduction of the Ostapek carbon composite spinal rod. Representing a breakthrough in manufacturing and design, the implant achieves higher performance by combining easy to use titanium poly-axial pedicle screws with an Ostapek rod, made of a proprietary biomaterial that is high density long fiber carbon composite. "Coligne's Ostapek composite spinal rod system improves implant performance and expands applications for spinal treatment", says Robert Lange, CEO, Coligne AG. "This product is the world's first carbon composite spinal rod and yet another milestone in our 12 year history of spine technology innovation."
Spine surgeons have used Ostapek composite technology for over a decade in Europe in the form of lumbar spinal plates and Interbody Fusion cages. In the USA Ostapek lumbar spinal fusion plates received FDA clearance for sale in 2005.
Ostapek surgical ap¬plications have included Interbody Fusions, spinal trauma and tumors. Testing and clinical applications have demonstrated biocompatibility, biomechanical perform¬ance and reliable clinical results. Now, the Coligne Ostapek composite rod system brings an established medical technology to another level.
"We have been waiting to expand Ostapek pedicle fixation to longer spinal fusions. To date, Ostapek composite rod cases are showing the same reliable performance we have seen using the Ostapek plating system over the last 10 years. However, the composite spinal rod technology is much easier to handle and could be used for broader applications." says Dr. Etienne Laloux, Orthopedic Clinic, Dijon, France.
In the past, traditional biomaterials such as titanium or simple plastics have performed below the spine surgeon's optimal requirements for spinal fusions. In some applications, traditional implants are either flexible but not strong enough to hold a spinal vertebra in position under normal body loads, or strong enough to hold correction, but too stiff to allow the natural give of a human bone.
Spinal rods made of Ostapek composite use controlled orientation of high density long carbon fibers to achieve the best combination of flexibility and strength. The composite components are manufactured in a matrix that is similar to healthy bone. This makes a weight bearing implant strong, yet flexible enough to stimulate surrounding bone over time.
"After surgery our Ostapek plate patients do not talk about their ‘stiff back' in the same way as our titanium implant patients" says Laloux.
Furthermore, Ostapek composite has none of the radiological artifact of metals, allowing surgeons and radiologists to observe the patient's early bone formation as well as the surrounding soft tissues, such as spinal nerves. Ostapek composite im¬proves implant fatigue resistance, the key to implant mechanical endurance, and also reduces implant corrosion which can lead to component loosening.
"Ostapek spinal rods will have applications in tumor surgery," says Dr. Alessandro Luzzati, head of spinal tumor treatment, Hospital of Cremona, Italy. "For tumor pa¬tients with spinal implant reconstruction, metal makes it difficult to administer radiation therapy after surgery. We have seen the advantages of composite in our spinal vertebral body re¬placement cage technology. Making posterior spinal fixation implants in composite will be another step forward."
about coLigne
Founded in 1990, coLigne AG Zurich, headquarter Zurich, Switzerland, develops and manufactures novel and practical spinal technologies including biomaterials. coLigne supplies leading edge imlpant technology to spinal surgeons worldwide. The company developed and manufactures ostaPek biomaterial, a long carbon fiber reinforced polymer: Now a key component providing new performance to spinal treatment implants, surgical systems and proceedues.
coLigne treatment technology products are manufactured in accordance with ISO 9001:2000 and ISO 13485:2003 and CFR 21 embracing the coLigne quality policy for spinal technology.
about the coAlliance
New technology requires new methods, technique and strategy. To ensure that these are properly taught and explored, coLigne founded the coAlliance, a community of like minded medical professionals devoted to the improvement of spinal treatment technology. coAlliance activities include "The Spine Surgeon's Workshop", which is held annually at the Medical University of Tours, France. Here experience is varied, multinational and based on the tenet, that all members have something to teach and learn. coAlliance workshops are based on participation, the exchange of competence and not hierarchy. Additional coAlliance activities include the "Designer Sessions", "Spine Strategy Host And Guest Tours" as well as "Encrypted Video Case Discussions" between sites in Europe and the USA.
about coLigne products
All coLigne treatment technology is for use only by a qualified and trained spinal surgeon. coLigne product availability in a specific country is subject to regional health care regulation. Not all products are available in specific countries. Some products are not yet cleared by the US-FDA. Contact your coLigne representative for availability details. Consult product inserts for product warnings and details.
ostaPek(R), evos(TM), gemitra(TM), trabis(TM), erriva(TM), coLigne(R), the coLigne Symbol(R) and a strategy in spine(R) are trademarks of coLigne AG.
Source: Coligne AG
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