KYPHON Cement Delivery System from Medtronic

Medtronic, Inc. (NYSE:MDT), today announced the full U.S. launch of the KYPHON Cement Delivery System (CDS), adding an innovative bone cement delivery option to its extensive KYPHON Balloon Kyphoplasty product portfolio for the treatment of vertebral compression fractures (VCFs).

The KYPHON Cement Delivery System allows physicians to keep a farther distance from the radiation source during the cement delivery phase than with Medtronic’s current delivery system used in the balloon kyphoplasty procedure. It allows for the delivery of KYPHON HV-R^® Bone Cement with one-handed operation, preserving some tactile feel during delivery with the ability to halt bone cement flow on demand with the quick-release button.

“With the CDS device, we are expanding the options for controlled delivery of bone cement into the vertebral body,” said Alex DiNello, vice president and general manager, KYPHON^® products, part of the Spinal and Biologics business at Medtronic. “As balloon kyphoplasty is adopted by more and more physicians as the treatment of choice for vertebral compression fractures, we will continue to deliver products, such as the CDS, that are designed with clinician safety in mind.”

“The CDS is another innovative product from Medtronic that increases physician safety by decreasing the radiation exposure exponentially,” said Dr. Thomas Andreshak, an orthopaedic surgeon with St. Vincent Hospital in Maumee, Ohio.

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 raise the height of the collapsed vertebra and return it to its normal height. 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 prevent further collapse.

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 and reduce leak pathways. The presence of the space also allows a more viscous bone cement to be injected under low manual pressure. These features are designed to potentially reduce the risk of leakage.

Medtronic has treated more than 700,000 fractures worldwide with balloon kyphoplasty and has trained approximately 14,000 spine specialists worldwide to perform balloon kyphoplasty.

Medtronic will introduce the KYPHON Cement Delivery System at the annual meeting of the Congress of Neurological Surgeons (CNS) in October and at the North American Spine (NASS) meeting in November.

http://www.medtronic.com/