Coligne Ostapek VBR receives FDA Market Clearance

USA (SANEPR.com) August 5, 2008 -- Coligne AG, a leading innovator in the design and manufacture of spinal implants, has received U.S. Food and Drug Administration market clearance for its unique Ostapek composite VBR devices for treatment of the thoracic and lumbar spine.

“Coligne engineers Ostapek’s composite long carbon fibers into a patented, high density sagittal plane configuration. This enables us to build VBR cages that simulate the bone trabecula architecture of a vertebral body”, explains Robert Lange, CEO, Coligne AG. Controlled carbon fiber orientation improves implant performance, ensuring primary support in one harmonious structure that presents bone-like mechanical strength without the stiffness of metal or the flow deformation of simple plastics. At the same time, this Ostapek composite configuration provides extra volume for graft to promote optimal bone healing needed in this type treatment. As Ostapek composite is radiolucent, bone formation can be observed thorugh the VBR implant. “The engineering required to meet the extreme demands of Veterbral Body Replament surgery will have many applications in the future,” says Lange.

The first VBR (Vertebral Body Replacment) surgeries using Ostapek composite were performed by Dr. Alessandro Luzzati of Cremona, Italy, to treat cancer patients. Here the diseased vertebra is removed en bloc and then replaced by an autologous bone graft filled Ostapek cage construct, secured with spinal pedicle fixation. “With today’s multidisciplinary oncological treatments and the surgical interventions that can now be performed, these patients are living longer. Some are completely cured and return to active life.,“ says Luzzati.

“Our experience with many metal VBR systems made us understand that the best long term stabilization we can provide patients would be to help them build a suitable bridge of growing bone to replace the vertebra that has been removed and achieve a definitive anterior arthrodesis. The Ostapek composite VBR design increases the volume of bone graft possible in a modular and stable construct, and we are convinced this improves the patient’s possibilities to create a viable, stable and definitive fusion”.

Research and clinical treatment with the Ostapek VBR continues to expand, for example with the Center for Musculoskeletal Surgery at the Charité University Hospital in Berlin, Germany. “We have used the device to treat several patients, the most recent involved implantation of an Ostapek VBR after the en bloc removal of 4 vertebra, the first time in our department”, says PD Dr. Klaus Schaser, Dr. A. Dish and Dr. Ingo Melcher of the Tumor and Spine Section at the Center for Musculoskeletal Surgery. ”Our early experimental and clinical results are encouraging. The Ostapek VBR has been the subject of two department publications We are working on another.”

Although new to the USA, Ostapek composite cage surgeries have been performed regularly in Europe since 1994. “It is rare in a surgeon’s career to be able to work with a new biomaterial,” said Dr. Kevin Lawson, an orthopadic surgeon in Sault Ste. Marie, USA. “We have used cobalt chrome, stainless steel, titanium and various plastics, but only recently have we been able to work with long fiber composites that are changing performance in other domains outside spine surgery. I have now used Ostapek lumbar plates with titanium screws in 50 patients. The plate has strength for correction and flexiblity that approaches bone. It is also radiolucent, allowing us to observe early bone formation through the foramen with normal x-ray. I am looking forward to using the Ostapek VBR.”

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 implant 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 procedures.

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 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®, evos™, gemitra™, trabis™, erriva™, coLigne®, the coLigne Symbol® and a strategy in spine® are trademarks of coLigne AG.
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Contact:
Felix Kraeft
coLigne AG
Utoquai 43, CH-8008
Zurich, Switzerland
0041 43 343 8000
Fax: 0041 43 343 8009
felix.kraeft@coligne.com
http://www.coligne.com

Dr. Dietmar Schaffarczyk
coLigne AG
Utoquai 43, CH-8008
Zurich, Switzerland
0041 43 343 8002
Fax: 0041 43 343 8009
dietmar.schaffarczyk@coligne.com
http://www.coligne.com