Medtronic (Minneapolis) has launched the T2 Sceptor Distractible End Cleats system, a vertebral body replacement device intended for use in the thoracic and lumbar spine to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma, such as a fracture.
Used in conjunction with Pyramesh C Surgical Titanium Mesh, the T2 Sceptor Distractible End Cleats system provides increased surface area and end-plate contact to help decrease the risk of dislodging post operatively.
"The vertebral body replacement device is intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma," Victor Rocha, a spokesman for the Medtronic Spinal & Biologics (Memphis) business, told Medical Device Daily. "The T2 Sceptor system must be used with both bone graft and supplemental fixation, just like mesh."
The system has multiple end cap angles and a broad range of sizes, both to accommodate individual patient anatomy. Coinciding with the launch, Medtronic said it has launched a new round mesh cutter that provides a smoother and more consistent mesh cut than traditional mesh trimmers.
More than 150,000 people suffer from traumatic fractures of the thoracic or lumbar spine each year. In more than 10,000 of these cases, one or more spinal vertebrae are so damaged that they require surgical removal and replacement with a vertebral body replacement device. Corpectomy procedures also may be done when a patient has cancer or a tumor that has resulted in spinal instability, pain and/or neurologic deficit.
"Treatment of fractures of the thoracic or lumbar spine may vary," Rocha said. "Examples of current treatment are titanium mesh alone, PEEK (Polyether-etherketone) stackables, expandable cages and allograft struts."
He said that the T2 Sceptor is the first device of its kind because, "It bridges the gap between traditional titanium mesh and newer expandable devices. It combines the graft volume of mesh with distraction capabilities."
The system must be used in conjunction with Pyramesh C Titanium centerpieces and with additional anterior and/or posterior spinal instrumentation to augment stability.
"The system provides increased surface area and end-plate contact to help decrease the risk of dislodging post operatively. The first of its kind, the system features multiple end cap angles and a broad range of sizes, both to accommodate individual patient anatomy. Mesh has traditionally been simply packed with bone graft and used to replace the vertebral body that has been removed," Rocha said.
He added that the FDA cleared and CE-marked device improves upon existing devices because mesh alone lacks distraction capabilities and the surface area the T2 Sceptor system cleats provide.
"Additionally, standard expandable devices lack the graft volume this system utilizes," he said.
Dean Karahalios, MD, a neurosurgeon at the Chicago Institute of Neurosurgery and Neuroresearch and the designer surgeon for the device, said, "The T2 Sceptor system and Mesh Cutter eliminate many of the frustrating aspects around sizing and cutting the titanium mesh, but more importantly, provides surgeons flexibility of an infinitely customizable titanium mesh solution with the benefits of an expandable cage platform."
Lynn Yoffee, 770-361-4789; firstname.lastname@example.org