Medtronic Rolls Out New Instrument and Implant

Even as the Spinal division of Medtronic Inc. defends its Infuse bone graft product, the company ismoving full steam ahead with adding new products to its portfolio.

In late June, Medtronic released additions to its instruments for its balloon kyphoplasty line as well as to its spinal screw offerings.

The Kyphon Xpander II Inflatable Bone Tamp (IBT) and the Kyphon Inflation Syringe—part of the Kyphon Xpander II IBT System—now are available for the treatment of vertebral compression fractures (VCFs). The other launch was the CD Horizon Fenestrated Screw Spinal System, which was released in Europe.

The new balloon material used in Kyphon Xpander II IBT System offers control during inflation and greater lifting force than the Kyphon Xpander IBT, according to the company. It is combined with the Kyphon Inflation Syringe, which provides ease of use to customers for use during a balloon kyphoplasty procedure. The Kyphon Xpander II IBT has been in physician-preference testing since November 2010 in more than 180 cases throughout the United States.

Vertebral compression fractures are the most common osteoporotic fractures with an estimated 900,000 spinal fractures occurring in the United States every year. These fractures have shown to increase the likelihood of additional health problems as well as increase the risk of death.

“Xpander II is a significant advancement to our existing kyphoplasty portfolio this year,” said Doug King, senior vice president and president of Medtronic Spinal. “Combined with the recent launches of the quick‐to‐dough Kyphon Xpede Bone Cement and Kyphon Express Curette, we are delivering our most innovative, best‐in‐class technology to treat patients suffering from vertebral compression fractures.”

During the minimally invasive balloon kyphoplasty procedure, a needle and tube are used to create a small pathway into the fractured bone, generally on both sides of the vertebral body. Orthopedic balloons are inserted and then inflated inside the fractured bone in an attempt to return it to its correct position. Inflation of the balloons creates cavities in the vertebral body that are filled with bone cement, forming an “internal cast” to support the surrounding bone and stabilize the fracture.

Balloon kyphoplasty differs from other surgical therapies for VCFs such as vertebroplasty, which is designed to stabilize the fracture without correcting vertebral body deformity or providing a controlled fill for bone cement distribution. With balloon kyphoplasty, inflation of the balloons compacts the cancellous bone, which may fill fracture lines. The presence of the space also allows a more viscous bone cement to be injected under low manual pressure.

New Screw System

Medtronic also launched its CD Horizon fenestrated screw spinal system in Europe. The devices are used in conjunction with fenestrated screw cement. Starting in Europe, this commercial release will be continued in India, Singapore and Australia in the coming months. It is not yet available in the United States.

The CD Horizon screw system provides surgeons an option for addressing patients with poor or compromised bone quality as a result of pathologies such as osteoporosis, a condition in which the bone becomes extremely porous, heals slowly and is subject to fracture. It includes a pedicle screw with additional holes in the tip to allow bone cement to be injected into a patient’s vertebral body. The cement then cures and provides enhanced fixation in the patient’s spine.

The system is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral spine.

No surgery, of course, comes without potential risk. According to Medtronic, possible negative outcomes of using the device include: disassembly, bending and/or breakage of any or all of the components, and tissue or nerve damage caused by improper positioning and placement of implants or instruments. Severe adverse events associated with the use of acrylic bone cements include cardiac arrest and embolism.

Medtronic’s orthopedic division islocated in Memphis, Tenn.