Descriptions and Indications for Use

Osseoflex™ 1.0 Description

The Osseoflex™ 1.0 Steerable Vertebral Augmentation Needle is a device used to disrupt 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 through the Osseoflex™ 1.0 Steerable Vertebral Augmentation Needle to fill the previously created void.

Osseoflex™ 1.0 Indications for Use

The Osseoflex™ 1.0 Steerable Vertebral Augmentation Needle is used during a vertebroplasty to fill a fractured vertebral body with polymeric bone cement. Painful pathological vertebral body compression fractures may result from osteoporosis, benign or malignant lesions such as metastatic cancers and myeloma.

The Osseoflex™ 1.0 Steerable Vertebral Augmentation Needle is used during a kyphoplasty to steer and channel through bone in the spine to create a void within a fractured vertebral body and fill the void with polymeric bone cement. Painful pathological vertebral body compression fractures may result from osteoporosis, benign or malignant lesions such as metastatic cancers and myeloma.

Osseoperm™ 1.0 Description

The Osseoperm™ 1.0 bone cement consists of an acrylic resin and a delivery system. Osseoperm™ 1.0 bone cement is a highly radiopaque acrylic resin of medium viscosity.

Osseoperm™ 1.0 Indication for Use

The Osseoperm™ 1.0 bone cement is indicated for the treatment of pathological fractures of the vertebral body using a vertebroplasty procedure.  Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).