FOR IMMEDIATE RELEASE
Eden Spine receives European CE Mark approval for its
Dynamic Stabilization System, the PERFX-2™
Wednesday, October 14th, 2009, 9:00 am ET
Lake Mary, Florida - Eden Spine (www.EdenSpine.com), a medical device company headquartered in Florida, announced today that it has received CE Mark approval for its proprietary posterior dynamic stabilization technology, the PERFX-2™.
“The PERFX-2™, developed with a team of orthopedic and neurosurgeons, is a complete polyaxial pedicle screw based dynamic stabilization system that has been developed to perfect the balance between motion and stability of a diseased spinal segment,” said Mourad Ben Mokhtar, Biomechanical Engineer and head of Eden Spine’s European R&D subsidiary, Eden Spine Europe SA.
Biomechanically, the Dynamic Rod component of the PERFX-2™ system possesses a unique proprietary dual spring mechanism allowing it to remove pain by; first stabilizing the diseased spinal segment; second, by controlling abnormal motion and abnormal load; and third by reproducing the natural kinematics of the spinal segment. The system has been designed to simply adapt itself to the motion characteristics of each patient, positively impacting the neutral zone, reducing the disc and facet loading and maintaining sagittal balance.
“An estimated 35% of fusion cases produce adjacent disc disease symptoms within a 5 year period following surgery, requiring additional follow-up surgeries” says Guillaume Viallaneix, CEO. “It is clear that this ratio is not acceptable clinically for the patient, and economically for the payer. The PERFX-2™ system has been designed specifically to address this very serious issue. Following in the footsteps of the international launch of our Interspinous Dynamic Stabilization system, the WELLEX™, the PERFX-2™ represents another opportunity for Eden Spine to positively impact patient care and gain market share in the high growth Dynamic Stabilization market segment.”
The PERFX-2™ is now available for international distribution, outside of the United States. It will be officially launched at the North American Spine Society meeting, held this year in San Francisco, California, November 10-14, 2009. Eden Spine will be exhibiting, booth #735.
As a technology driven organization, Eden Spine LLC, a privately held spine company headquartered in Lake Mary, Florida, is positively impacting patient care developing tomorrows’ spinal technologies and building a world class spine franchise with a fiscally sound sales & distribution network. The Eden Spine Group has developed 5 proprietary technologies including three new-generation, non-fusion technologies; the WellDisc™ total disc replacement; the FX1™ Dynamic Stabilization System, and the Wellex™ Interspinous Technology. Eden Spine currently distributes a range of FDA-cleared and CE Marked technologies in the US and internationally.
Guillaume Viallaneix, CEO, Phone: 407 792 2279 - Fax: 407-264-8303 - e-mail:
Headquarters: Eden Spine, LLC - 801 International Parkway - 5th Floor - Lake Mary, FL 32746 - USA
Research & Development: Eden Spine Europe SA - Bd Helvetique, 36 - 1207 Geneva- Switzerland
Web address: http://www.EdenSpine.com