FDA clears StaXx XDL expandable vertebral body replacement device


The US Food and Drug Administration has cleared Spine Wave’s StaXx XDL expandable vertebral body replacement device. The StaXx XDL system is the latest addition to the family of PEEK spacers utilising Spine Wave’s proprietary expandable technology. 

The StaXx XDL expandable device (Spine Wave) is the company’s first device intended to be implanted using a lateral surgical approach.

“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 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.”

“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.”