The device enables surgeons to restore normal spinal alignment and balance during open or MIS TLIF approaches
Spine technology company Spinal Elements has secured approval from the US Food and Drug Administration (FDA) for its Lucent XP-Curved expandable interbody device.
Lucent XP-Curved is said to be the third platform in the Lucent XP expandable device portfolio and the fifth expandable device within the company’s MIS Ultra suite of products and procedures.
The device, along with its instrumentation, facilitates the steerable placement of the intervertebral implant followed by the expansion of the implant’s height upon the surgical placement.
Lucent XP-Curved device to be made available in three lengths
Spinal Elements is offering the Lucent XP-Curved device in three lengths with multiple lordotic options of up to 15° to help surgeons restore normal spinal alignment and balance during open or MIS TLIF approaches.
Lucent XP devices, which are made of polyetheretherketone (PEEK), feature the company’s Ti-Bond porous titanium coating.
Ti-Bond is a hydrophilic porous titanium coating with nano-scale surface features. It has been used in multiple fusion procedures of the company.
Spinal Elements is planning to commercially launch the Lucent XP-Curved device in the coming months. The company launched the MIS Ultra platform in 2020.
MIS Ultra platform’s surgical instruments have been designed to minimise the disruption of the patient’s skeletal and muscle tissue.
The implants have been designed to balance the loads shared between the implants and the body while not disturbing the patient’s surrounding healthy anatomy, said the company.
Spinal Elements president and CEO Jason Blain said: “We are thrilled to add this device and procedural solution to the MIS Ultra portfolio.
“With the recently announced acquisition of the Orbit discectomy technology and the introduction of new expandable platforms such as Lucent XP-Curved, Spinal Elements is able to provide an increasing number of comprehensive solutions to our spine surgeon customers.”
In December 2020, Spinal Elements acquired certain assets from Benvenue Medical, a developer of MIS lumbar fusion systems, for an undisclosed amount.