DePuy Synthes Spine Launches Two New Devices at NASS

DePuy Synthes Spine, part of the Johnson & Johnson Family of Companies, launched two new devices at the 31st Annual Meeting of the North American Spine Society (NASS).

The SYNFIX Evolution System is an implant for stand-alone anterior lumbar interbody fusion (ALIF). The system delivers biomechanical stability to promote fusion and restore function, coupled with instrumentation designed to optimize surgical workflow. It also offers a broad range of implant options to accommodate various patient anatomies.
 
The use of stand-alone ALIF, in which the spine is accessed through the abdomen, is growing 3 percent globally each year due to reduced complication rates compared to fusion surgery performed through the patient’s back.² Multiple studies of SYNFIX implant technology show it provides superior biomechanical stability compared to other stand-alone ALIF implants and equivalent biomechanical stability relative to lumbar fusion performed through the back.^1,3
 
“Biomechanical stability in an implant is paramount,” said Alexandre Rasouli, M.D., of Cedars-Sinai Medical Center. “It is the difference between a single-stage surgery and a more involved multi-stage surgery that can increase complications and drive up costs.”
 
The SYNFIX Evolution System consists of a PEEK (polyether ether ketone) spacer coupled with a titanium zero-profile plate and four divergent locking screws, which create a wedge of bone that helps anchor the implant during the healing process. The range of implant options allows the surgeon to accommodate varying patient anatomies and restore spine balance. The SYNFIX Evolution System also increases surgical efficiency by reducing the number of instruments and increasing screw insertion speed. The SYNFIX Evolution System design team engineered a thread lock sleeve to capture the screw to the screwdriver, preventing the screw from becoming disengaged during surgery.
 
“DePuy Synthes has been providing solutions for stand-alone ALIF procedures for more than a decade, and we are committed to investing in this market to ensure we continue to meet the needs of our customers and patients,” said Dan Wildman, platform leader at DePuy Synthes Spine. “The launch of the SYNFIX Evolution System shows that we continue to respond to our customers by developing a product that is easy to use while helping improve operating room efficiency.”
 
DePuy Synthes Spine also launched the ZERO-P NATURAL Plate at NASS, a device that helps maintain stability and support bone growth in spinal fusion procedures in the neck. The ZERO-P NATURAL Plate is designed for use with the CC Natural spacer, an allograft spacer that offers structural support and fusion potential.
 
The anterior plate and CC Natural allograft spacer are assembled together outside of the operating room, allowing for simultaneous insertion into the disc space during anterior cervical discectomy fusion (ACDF) procedures. The ZERO-P NATURAL Plate is anchored by four locking screws, which form a rigid bone wedge for stability.⁴
 
Allograft interbody spacers are considered a primary choice for ACDF, representing 50 percent of all implanted cervical fusions.⁵ These spacers, including the CC Natural allograft spacer, work as a bridge to allow the natural bone to grow through the surface to support fusion.
 
The ZERO-P NATURAL Plate is the newest addition to the DePuy Synthes zero-profile family of products, which do not protrude past the anterior wall of the vertebral body, limiting the risk of damage to vessels and adjacent soft tissue. These plates are designed to prevent contact with adjacent levels. Cervical plates placed near adjacent level discs may contribute to bone formation near or around the adjacent level.⁶

“Compared to ACDF with a traditional plate and allograft, there is no need to expose the vertebral bodies beyond their endplates, resect anterior osteophytes, or remodel the anterior surface of the vertebral bodies,” said Peyman Pakzaban, M.D., F.A.A.N.S., of Houston MicroNeurosurgery in Texas. “The insertion of a pre-fabricated allograft and the zero-profile plate is performed in one combined step.”
 
Dan Wildman, platform leader, DePuy Synthes Spine added, “DePuy Synthes has a strong track record in providing solutions that help improve patient outcomes in cervical spine fusion, and the ZERO-P NATURAL Plate is the latest example of our focus on innovation that serves customers and patients while promoting surgical efficiency.”
 
The CC Natural allograft spacer is processed by the Musculoskeletal Transplant Foundation, following stringent standards in tissue quality and safety through their approach to donor selection and allograft processing.

 
DePuy Synthes provides orthopedic solutions in specialties including joint reconstruction, trauma, neurological, craniomaxillofacial, spinal surgery and sports medicine.

References:
1. Biomechanical comparison of stand-alone anterior lumbar interbody fusion devices with secured fixation: Four-screw locking plate vs Three-screw variable angle vs. blade fixation. Freeman, A, et al., et al. Las Vegas, USA : s.n., 2016. ISASS.
2. DePuy Synthes Internal Estimates and Third Party External Market Research Reports. (DSUS/SPN/0516/1329)
3 A new stand-alone anterior lumbar interbody fusion device: Biomechanical comparison with established fixation techniques. Cain, C MJ, et al., et al. 23, s.l. : Lippincott Williams & Wilkins, Inc, 2005, Spine, Vol. 30, pp. 2631-2636.
4. Bench test results may not necessarily be indicative of clinical performance. The ZERO-P NATURAL Plate and an MTF CC Natural allograft spacer was compared to a one level VECTRA-ONE ™ Cervical Plate with an MTF CC Natural allograft spacer in a cyclic cadaveric range of motion study. The ZERO-P NATURAL Plate was also compared to a one level VECTRA-ONE Cervical Plate in mechanical testing per ASTM F1717. Test numbers 0000220895 and 0000252409.
5. Millenium Research Group, US Markets for Spinal Implants  2013, Table 178: Cervical IBD Fusions, by Material, US
6. Park, J.B., Y.S. Cho and K.D. Riew. 2005. “Development of adjacent-level ossification in patients with an anterior cervical plate.” J. Bone Joint Surg. Am. 87:558-563.