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Osseon Osseoflex SB wins CE mark

Osseon Therapeutics has obained CE mark approval for its Osseoflex steerable balloon (SB) to treat vertebral compression fractures (VCFs).

Osseoflex SB employs an unipedicular approach which allows it to navigate with unprecedented precision, accuracy, and control within the vertebra, thus creating a central cavity across the sagittal midline or in other specific areas within the vertebral body.

Osseon Therapeutics CEO John Stalcup said 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," Stalcup said.

The company’s medical device systems uses a proprietary steerable devices to correct fractures of the spinal vertebrae, using a procedure called Osseoplasty.