The Vu e-POD and Vu L-POD received clearance from the United States Food and Drug Administration (FDA) to be marketed as a spinal IBD. Prior to receiving the IBD status, the devices were cleared by the FDA as spinal vertebral body replacement devices (VBR).
The dual classification of the Vu e-POD and the Vu L-POD gives the surgeon a broader range of usages. As an IBD, they are used as an adjunct to fusion in patients with degenerative disc disease at one or two contiguous levels (L2-S1). As a VBR, they may be used to replace a collapsed, damaged or otherwise unstable vertebral body due to tumor or trauma (T1-L5).
The Vu e-POD's unique technique of distraction during insertion reduces the amount of steps and instruments required to perform the surgery. This contributes to decreasing the length of time needed to perform the procedure. (U.S. Patent No. 6,290,724 licensed from NuVasive, Inc.)
Randy Theken, President, Integra Spine, states, "The Vu e-POD all-in-one insertion and distraction technique gives Integra Spine a true competitive advantage. It leads to benefits for both the surgeon and patient. No longer is a second instrument required to distract the disc space. It is accomplished through a simple rotation technique performed after inserting the device."
IBDs are small hollow spinal implants that are inserted into the intervertebral space to restore physiological disc height and to allow fusion between vertebral bodies. These devices relieve pressure on the nerves and associated back pain by maintaining the native disc space height and by providing positive mechanical stabilization for fusion. The graft window allows natural bone growth to occur through the graft and form a strong vertebral union along with the implant. The IBD market for 2008 is estimated at $1,045M with a CAGR of 3.0% through 2012 (Millennium Research Group, 2007).
The Vu e-POD and Vu L-POD are distributed through the Integra Spine independent distributor network. Integra Spine is a leading provider of fusion implants, motion preservation devices and orthobiologics used in spinal surgery. Integra Spine provides a comprehensive product line from occiput to sacrum. Visit www.integraspine.com for more information.
Integra LifeSciences Holdings Corporation, a world leader in regenerative medicine, is dedicated to improving the quality of life for patients through the development, manufacturing, and marketing of clinically relevant, innovative, and cost-effective surgical implants and medical instruments. Integra's products, used primarily in neurosurgery, orthopedics and general surgery, are used to treat millions of patients every year. The company's headquarters are in Plainsboro, New Jersey, and it has research and manufacturing facilities throughout the world. For more information visit http://www.Integra-LS.com
Integra LifeSciences Holdings Corporation
John B. Henneman, III, Executive Vice President, Finance and
Administration, and Chief Financial Officer
Gianna Sabella, Public Relations Manager