08.31.11
Spine Wave Inc. has received clearance from the U.S. Food and Drug Administration to market the StaXx XDL Expandable Device.
“We are excited to bring the StaXx XDL Expandable Device to the U.S. market,” Mark LoGuidice, chairman and CEO of the Shelton, Conn.-based company said. “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.”
The StaXx XDL System is the latest addition to the family of PEEK (polyetheretherketone) spacers that uses expandable technology, and is the company’s first that is intended to be implanted using a lateral surgical approach.
Jürgen Harms, M.D., medical director, orthopedics and spinal column surgery at Klinkikum Karlsbad-Langensteinbach in Karlsbad, Germany, has been involved with the device’s development since its early stages. “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,” Dr. Harms said.
“We are excited to bring the StaXx XDL Expandable Device to the U.S. market,” Mark LoGuidice, chairman and CEO of the Shelton, Conn.-based company said. “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.”
The StaXx XDL System is the latest addition to the family of PEEK (polyetheretherketone) spacers that uses expandable technology, and is the company’s first that is intended to be implanted using a lateral surgical approach.
Jürgen Harms, M.D., medical director, orthopedics and spinal column surgery at Klinkikum Karlsbad-Langensteinbach in Karlsbad, Germany, has been involved with the device’s development since its early stages. “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,” Dr. Harms said.