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FDA clears ArthroCare vertebral augmentation device

ArthroCare, a provider of minimally invasive surgical products, has received clearance from the US Food and Drug Administration (FDA) to market its Parallax Contour, an enhanced vertebral augmentation device specifically for void creation in a vertebral body followed by injection of bone cement.

Vertebral augmentation, also referred to as vertebroplasty or kyphoplasty, is commonly used to treat painful vertebral compression fractures.

ArthroCare said the new lower profile device makes it easier for surgeons to operate in tight spaces and to provide additional tactile and audible feedback to improve ease of use during the void creation process.

The Contour-enhanced utilizes a curved, movable stylet to displace cancellous bone within vertebrae, creating a void, which is then filled with bone cement to stabilize the fracture.

The Contour-enhanced is indicated for procedures to create a void in the vertebral body and fill the void with Parallax Acrylic resin (bone cement).