In the fall, Stryker made a big impact the annual North American Spine Society (NASS) conference, introducing new products that hold promise of transforming the field. Although the innovations were strikingly new, they reflected years of intensive development fueled by surgeon feedback.
To learn more, Surgical Products interviewed Bradley Paddock, president of Stryker’s Spine division.
What can you tell us about the products Stryker introduced at NASS in the fall?
The North American Spine Society’s 2017 Annual Meeting was an exciting one for Stryker’s Spine division. The company introduced two key products: The Tritanium C Anterior Cervical Cage, a 3D-printed interbody fusion cage intended for use in the cervical spine, and the Serrato pedicle screw, a unique dual-lead screw intended for use in the non-cervical spine.
The Tritanium C Anterior Cervical Cage is the newest addition to Stryker’s expanding line of spinal implants constructed from its proprietary Tritanium Technology, a novel, highly porous titanium material designed for bone in-growth and biological fixation.
The unique porous structure of Tritanium is created to provide a favorable environment for cell attachment and proliferation, as demonstrated in an in-vitro study, and the Tritanium material may be able to wick or retain fluid, in comparison to traditional titanium. It is inspired by the microstructure of cancellous bone and enabled by AMagine, Stryker’s proprietary approach to implant creation using additive manufacturing, also known as 3D printing. The Tritanium C Anterior Cervical Cage received 510(k) clearance from the U.S. Food and Drug Administration in September 2017.
The Serrato pedicle screw is the first dual-thread screw with enhanced cutting flutes (serrations) that are designed to reduce work by lowering the insertion torque, and True-Tip geometry, which allows for precise insertion and immediate bone engagement. These design innovations elevate one of the most basic spinal surgery tools, with the goals of reducing work, increasing speed, and enhancing surgical efficiency.
The Serrato pedicle screw is part of Stryker’s Xia 3 Spinal System. The screws accommodate a variety of rod diameters and materials to suit the patient’s needs — 5.5 and 6.0mm diameter rods in commercially pure titanium, titanium alloy, and Vitallium. The Serrato pedicle screw received 510(k) clearance from the U.S. Food and Drug Administration in May 2017.
What specific needs for surgeons does the Tritanium C Anterior Cervical Cage meet?
The Tritanium C Anterior Cervical Cage follows the success of the Tritanium PL Posterior Lumbar cage, and brings the benefits of implants that are designed to mimic the porosity of bone to cervical fusion procedures. Tritanium Cages feature ‘precisely randomized’ pore formations, in contrast to other technologies with longitudinal channels and traverse windows that create a uniform structure, as well as cages that offer porosity only on the surface. As a result, Tritanium implants are designed to become ‘one with bone’.
Dr. Jocelyn Idema, a spine surgeon with Advanced Orthopaedics and Rehabilitation in Pittsburgh and Washington, Pennysylvania said, “The ultimate goal with spinal implants is to get a solid fusion. Spinal implants created with Tritanium Technology mimic the porosity of cancellous bone, which aids in fusion.”
The Tritanium C Anterior Cervical Cage also features an open central graft window and lateral windows to help reduce stiffness of the cage and minimize subsidence. In addition, the large graft window allows for bone graft containment. Engineered for stability, the cage has precisely angled teeth on the superior and inferior surfaces designed for bidirectional fixation and to maximize surface area for endplate contact with the cage. Its smooth posterior edges are designed to facilitate insertion and protect soft tissue and anatomy.
The Tritanium C Anterior Cervical Cage is offered in a number of footprints, heights, and lordotic angles to accommodate a variety of patient anatomies.
And how does the Serrato Pedicle Screw meet surgeons’ needs?
Pedicle screws have been used for decades with very few changes to their design. Stryker’s design innovations elevate one of the most basic spinal surgery tools, with the goals of reducing work, increasing speed, and enhancing surgeon efficiency.
At the recent NASS meeting, surgeons visiting the Stryker Spine booth participated in a tabletop demonstration comparing the Serrato pedicle screw with conventional screw designs — experiencing firsthand the increased efficiency and ease of insertion due to the enhanced cutting flutes (serrations) that give Serrato its name, as well as True-Tip geometry. This is important, as up to 20 screws or more can be placed during complex spinal procedures.
What kind of feedback have you gotten from surgeons?
Feedback from surgeons has been exceeding expectations.
Alexander R. Vaccaro, MD, PhD, MBA, one of the first surgeons to integrate Serrato, said, “The Serrato pedicle system from Stryker has added a new level of versatility to the armamentarium that a spine surgeon has in all complex spinal procedures. The new screw design affords excellent screw purchase.”
Roderick Sanden, MD, an orthopedic surgeon with Advanced Neurospinal Care and Sutter Roseville Medical Center in Northern California, who was one of the first 100 surgeons to implant the Serrato pedicle screw, told us, “Game-changing screw. I never thought a pedicle screw made that much of a difference until I put in a Serrato screw.”
Scott Luhmann, MD, Head of Surgery, Pediatric Orthopaedics at Shriners Hospital for Children in St. Louis, said, “The Serrato screw insertion was exactly what I was hoping for. It allowed for easy initiation of the screw, good tactile feedback, and excellent purchase!”
Can you talk about how additive manufacturing informs the design process?
Stryker’s high-resolution additive manufacturing process allows the company to push beyond the constraints of conventional manufacturing to create new implant designs. The process enables Tritanium cages to be designed and built with pinpoint precision, optimizing pore size, porosity, geometry, and surface texture to help achieve fusion.
While additive manufacturing may appear to be a recent development in the creation of spinal implants, Stryker began collaborations with top doctoral programs at leading universities in the United Kingdom and Ireland in 2001 to industrialize 3D printing for the healthcare industry. Tritanium is the culmination of more than 15 years of extensive research, development, and validation in material science and manufacturing, and it has been utilized clinically in hip and knee applications for more than 10 years — with more than 300,000 orthopaedic devices implanted.
In fact, the manufacturing of Tritanium technology is now in its third generation, and today Stryker makes and sells more orthopaedic implants using additive manufacturing than any company in the world.
The new Serrato pedicle screw also reflects the company’s focus on technology innovation. Pedicle screws have been used for decades with very few changes to their design. The design innovations incorporated into Serrato reinforce Stryker’s commitment to making industry-leading investments focused on providing the advanced spinal products and differentiated technologies to meet the needs of surgeons and their patients.