02.24.14
Carlsbad, Calif.-based Aurora Spine Corporation has received Australian Therapeutic Goods Administration (TGA) clearance for its Zip Ultra interspinous fusion system. The Zip is a minimally invasive (MIS) spinal fixation device for spinal fusion and was developed as an alternative to the pedicle screw systems prevalent in the market.
The TGA, like the U.S. Food and Drug Administration in the United States, is responsible for regulating medical devices in Australia. TGA is part of the Australian Government Department of Health and its authority extends over therapeutic goods, including medicines, medical devices and blood and blood products.
“The receipt of the TGA clearance is a significant step forward in Aurora Spine’s expansion into the global minimally invasive spinal device market,” said Brent Johnston, chief commercialization officer of Aurora Spine. “Aurora Spine will continue to strive to bring improved fusion technology to patients and position itself as a leader in spinal technology.”
Just one week prior to Australian clearance, Aurora Spine coimpleted the first surgical implant of Zip Ultra in the United Kingdom. The surgery was performed at the University Hospital Llandough, a part of the Cardiff and Vale University Health Board, by spine surgeon Stuart James, M.D.
“The Zip MIS implant is very well designed. It is both stable and secure. Implanting the device was simple, easy and safe,” said James. “I will be expanding my use of the product as I believe it has multiple spine fusion indications.”
“We are absolutely thrilled that Aurora now offers our MIS portfolio in the United Kingdom, including the Zip MIS interspinous system,” said Trent Northcutt, president and CEO of Aurora Spine. “We believe that the Zip device will change spine surgery in the United States with a true minimally invasive approach designed to achieve reproducible, superior patient outcomes. We are eager to introduce the ZIP across the United Kingdom, and to drive the shift toward minimally invasive techniques. Our initial reception in the United Kingdom has been fantastic, and we want to thank James for his support of the Aurora vision.”
The device is also being sold in European Union countries including Germany and Italy.
The first U.S. implantation of Zip Ultra was completed in December at Southern California Hospital in Culver City, Calif.
Aurora Spine is an early stage company focused on bringing new solutions to the spinal implant market through a series of innovative, minimally invasive, regenerative spinal implant technologies.
The TGA, like the U.S. Food and Drug Administration in the United States, is responsible for regulating medical devices in Australia. TGA is part of the Australian Government Department of Health and its authority extends over therapeutic goods, including medicines, medical devices and blood and blood products.
“The receipt of the TGA clearance is a significant step forward in Aurora Spine’s expansion into the global minimally invasive spinal device market,” said Brent Johnston, chief commercialization officer of Aurora Spine. “Aurora Spine will continue to strive to bring improved fusion technology to patients and position itself as a leader in spinal technology.”
Just one week prior to Australian clearance, Aurora Spine coimpleted the first surgical implant of Zip Ultra in the United Kingdom. The surgery was performed at the University Hospital Llandough, a part of the Cardiff and Vale University Health Board, by spine surgeon Stuart James, M.D.
“The Zip MIS implant is very well designed. It is both stable and secure. Implanting the device was simple, easy and safe,” said James. “I will be expanding my use of the product as I believe it has multiple spine fusion indications.”
“We are absolutely thrilled that Aurora now offers our MIS portfolio in the United Kingdom, including the Zip MIS interspinous system,” said Trent Northcutt, president and CEO of Aurora Spine. “We believe that the Zip device will change spine surgery in the United States with a true minimally invasive approach designed to achieve reproducible, superior patient outcomes. We are eager to introduce the ZIP across the United Kingdom, and to drive the shift toward minimally invasive techniques. Our initial reception in the United Kingdom has been fantastic, and we want to thank James for his support of the Aurora vision.”
The device is also being sold in European Union countries including Germany and Italy.
The first U.S. implantation of Zip Ultra was completed in December at Southern California Hospital in Culver City, Calif.
Aurora Spine is an early stage company focused on bringing new solutions to the spinal implant market through a series of innovative, minimally invasive, regenerative spinal implant technologies.