Medtronic launches cement delivery system for balloon kyphoplasty in Europe

Medtronic, Inc. today announced in a press release the European launch of the Kyphon Cement Delivery System, adding an innovative bone cement delivery option to its Kyphon Balloon Kyphoplasty product portfolio for the treatment of vertebral compression fractures (VCFs).

The Kyphon Cement Delivery System (CDS) 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 ActivOs and 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. The Kyphon Cement Delivery System was launched in the United States in September 2009, according to the release.

Medtronic introduced the CDS at the annual meeting of the Spine Society of Europe (EuroSpine) in Vienna.

“With the CDS device, we are expanding the options for controlled delivery of bone cement into the vertebral body,” Alex DiNello, vice president and general manager, Kyphon products division, stated in the release. “As Kyphon 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 and patient safety in mind.”

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, the company noted. 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 says it has treated more than 700,000 fractures worldwide with balloon kyphoplasty and has trained approximately 14,000 spine specialists worldwide to perform the procedure. The complication rate with Kyphon Balloon Kyphoplasty has been demonstrated to be low. There are risks associated with the procedure (eg, cement leakage), including serious complications, and though rare, some of which may be fatal, according to the press release. This procedure is not for everyone; a prescription is required. Patients should consult their physicians for a complete list of indications, contraindications, benefits, and risks. Only patients and their physicians can determine whether this procedure is right for a particular patient, Medtronic noted.