New Steerable Balloon Vertebral Augmentation Device Gains CE Mark

“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”

In short

Osseon® Therapeutics, Inc. has announced that its vertebral augmentation device, the Osseoflex® SB (steerable balloon), has received CE Mark approval for commercial release in the European Union.

The company claims its Osseoflex SB’s innovative technology represents a game changing development for the treatment of vertebral compression fractures (VCFs).

Background

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.

According to its news release, the Osseoflex® steerable balloon can be navigated 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 reportedly 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 as well as in other regions where CE mark approval is accepted.

Company comments

“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.

Source: Osseon