27 Jan Spinal Elements® Announces FDA Clearance of Lucent® XP-Curved Expandable TLIF Device
CARLSBAD, Calif.–(BUSINESS WIRE)–Spinal Elements, a spine technology company, today announced the FDA clearance of the Lucent® XP-Curved Expandable Interbody Device. Lucent XP-Curved is the third platform in the Lucent XP family of expandable devices and the fifth expandable device within Spinal Elements’ MIS Ultra™ suite of products and procedures. The device and its instrumentation allow for the steerable placement of the intervertebral implant followed by the expansion of the implant’s height once surgically placed. The company’s line of expandable devices has demonstrated impressive adoption and growth, and the company believes this addition will continue that success.
The Lucent XP-Curved device will come in three lengths with multiple lordotic options of up to 15° to assist surgeons in restoring normal spinal alignment and balance during open or MIS TLIF approaches. The devices comprising the Lucent XP family are made primarily of polyetheretherketone (PEEK) and feature Spinal Elements’ Ti-Bond® porous titanium coating. Ti-Bond is a hydrophilic porous titanium coating with nano-scale surface features that has been used in tens of thousands of Spinal Elements fusion procedures.
Matt Colman, M.D. of Rush University Medical Center in Chicago, IL says of the Lucent XP-Curved system, “Lucent XP-Curved contains the ideal combination of TLIF device attributes. I can perform cantilever segmental correction using a more ALIF-like footprint while taking advantage of the benefits of in-situ expandability. Additionally, the radiolucency of the PEEK and Ti-Bond construction allows me to confidently assess the healing process throughout the patient’s recovery, providing increased surface area and stability while promoting fusion.”
Wade Jensen, M.D. of the Center for Neurosciences, Orthopedics, and Spine (CNOS) in Dakota Dunes, SD adds, “With up to 15° of lordosis, I expect the expandable Lucent XP-Curved device to restore height while optimizing lordosis to achieve sagittal correction, which is critically important to long-term successful outcomes.”
“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,” stated Jason Blain, President and CEO of Spinal Elements.
The commercial introduction of the Lucent XP-Curved device is expected in the coming months. Spinal Elements introduced the MIS Ultra platform last year. Traditionally, MIS procedures have been focused on the size of the incision required for access to the spine. The MIS Ultra product suite goes beyond small incisions to consider the implications of spine surgery after the procedure has taken place. The surgical instruments of the MIS Ultra platform have been designed to reduce the disruption of the patient’s skeletal and muscle tissue, and the implants have been designed to balance the loads shared between the implants and the body while not disrupting the patient’s surrounding healthy anatomy.
Spinal Elements is a Carlsbad, California based medical device company focused on the design, development and commercialization of a comprehensive portfolio of systems, products and technologies for spine surgery procedures. A leading designer, developer, manufacturer and marketer of innovative medical devices used in spinal surgical procedures, Spinal Elements combines leading medical device technologies, biologics and instrumentation to create positive surgical outcomes that exceed surgeon and patient expectations. Spinal Elements has built a reputation delivering innovative and differentiated technologies that enable fundamental shifts in solutions for spine surgery. The company markets a complete portfolio of advanced spinal implant technologies. For more information, please visit www.spinalelements.com.