Osseon's new vertebral augmentation device receives European CE Mark approval

Feb 22 2012

Osseon® Therapeutics, Inc. announced today that its newest product for vertebral augmentation treatment, the Osseoflex® SB (steerable balloon), received CE Mark approval for commercial release in the European Union.  Osseoflex SB's innovative technology represents a game changing development for the treatment of vertebral compression fractures (VCFs).  Employing a unipedicular approach, the steerable Osseoflex SB can navigate with unprecedented precision, accuracy, and control within the vertebra to create a central cavity across the sagittal midline or in other specific areas within the vertebral body.  This minimally invasive, single-point-access reduces procedure time and decreases risk to the patient compared to systems requiring multiple access points. 

CE Mark approval for Osseoflex SB permits surgeons and other physicians throughout Europe to use Osseoflex SB for the treatment of symptomatic spinal fractures.  Numerous countries in other regions, including Asia, South America, and the Middle East also accept CE Mark approval as proof of clinical suitability, allowing Osseon's innovative technology to be used in markets comprising more than one billion people.

Osseon's medical device systems employ proprietary steerable devices to correct fractures of the spinal vertebrae, using a procedure called Osseoplasty®.  Hundreds of thousands of patients suffer from VCFs in the U.S. and Europe annually due to osteoporosis, acute trauma, or degenerative bone and joint disease.  "The capability to access the entire vertebra through a single point of access reduces procedure time and decreases pain and risk to the patient compared to current systems requiring multiple access points.  These are significant clinical enhancements over existing kyphoplasty systems," said John Stalcup, Ph.D., CEO of Osseon.