Vertebral Augmentation Through a Single Access Point

The Osseoflex Steerable Balloon (SB) vertebral augmentation device is a minimally invasive, single-point-access system that reduces procedure time and decreases risk to the patient. The system employs a unipedicular approach, navigating with 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.

The device is based on the principles of Osseoplasty, a proprietary minimally invasive system that utilizes a steerable needle for navigating the vertebral body and the delivery of bone cement for the treatment of symptomatic VCFs. The process involves disruption of cancellous bone by steering and channeling through the bone, creating a void within a vertebral body. After the bone is disrupted, polymeric bone cement is injected to fill it. The Osseoflex Steerable Balloon (SB) vertebral augmentation device is a product of Osseon Therapeutics (Santa Rosa, CA, USA), and has received the European Community marking of approval (CE).

“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,” said John Stalcup, PhD, CEO of Osseon. “These are significant clinical enhancements over existing kyphoplasty systems.”

A VCF may be due to trauma or due to a weakening of the vertebra. This weakening is seen in patients with osteoporosis or osteogenesis imperfecta, lytic lesions from metastatic or primary tumors, or infection. In healthy patients, it is most often seen in individuals suffering extreme vertical shocks, such as ejecting from a jump seat. Seen in lateral views in plain X-ray films, compression fractures of the spine characteristically appear as wedge deformities, with greater loss of height anteriorly than posteriorly and intact pedicles in the anteroposterior view.

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Osseon Therapeutics