Healthcare Industry News:  vertebral augmentation 

Devices Orthopaedic Neurosurgery FDA

 News Release - August 29, 2011

Spine Wave Announces FDA Clearance of the StaXx(R) XDL Expandable Device

SHELTON, CT--(Healthcare Sales & Marketing Network)- Spine Wave, Inc. today announced that the Company received FDA clearance to market the StaXx® XDL Expandable Device. The StaXx® XDL System is the latest addition to the family of PEEK spacers utilizing Spine Wave's proprietary expandable technology. The StaXx® XDL Expandable Device is the company's first device intended to be implanted using a lateral surgical approach.

"We are excited to bring the StaXx® XDL Expandable Device to the US market," said Mark LoGuidice, Spine Wave Chairman and CEO. "This milestone further demonstrates our commitment to the development of new products based on our proprietary expandable technology. We will continue to invest heavily in the development of differentiated technologies as we broaden our product portfolio."

"I have been using the StaXx® technology from a posterior approach since 2008 and I fully appreciate the unique in situ expansion and distraction capabilities," commented Prof. Dr. med. Jürgen Harms, SRH Klinikum Karlsbad-Langensteinbach,Karlsbad Germany. "I am pleased to have been involved in the development and early clinical work of the StaXx® XDL System. This important new device is meeting or exceeding all of my expectations and while the clinical results are still very preliminary, my early experience has been very favorable."

About Spine Wave

Spine Wave is committed to the development and delivery of high-quality innovative medical devices for the treatment of spinal disorders. The Company is focused on commercializing technology platforms that offer spine surgeons novel and useful solutions to common surgical problems. The Company's product portfolio includes the StaXx® XD Expandable Device, StaXx® XDL Expandable Device, CapSure® PS2 Spine System, Sniper® Spine System, StaXx® FX Percutaneous vertebral augmentation, NuCore® Injectable Nucleus, and several additional products in development. For further information, visit the Company's website at

Source: Spine Wave

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