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Voice of Industry

Additive, Materials and Robotics Remain Spine Companies' Product Focus

By Carolyn LaWell and Julie A. Vetalice

We met with surgeons, device companies and suppliers at the North American Spine Society (NASS) Annual Meeting and walked away with the impression that OEMs seek a broad portfolio that requires different manufacturing processes and products, other than hardware alone, to drive their revenue during a time of slow procedural volume.

For example, the topics that resonated in exhibit hall conversations and surgeon presentations were advancements in additive manufacturing or 3D printing, replacement or coating of traditional PEEK and the adoption of robotics and navigation. While larger spine companies are already pursuing these technologies, we noticed that mid-sized down to startup players are prioritizing some or all in their product development pipelines.

We know that hundreds of companies—thousands of people—were on hand at the 2017 event. Here’s a recap of just five conversations that we had on the exhibit hall floor. We chose these five because they speak to the aforementioned technology trends and give insight into future product launches.

DiFusion Technologies
Derrick Johns, President and CEO

DiFusion Technologies added zeolite molecules to Solvay’s Zeniva ZA-500 PEEK to change the material to a negatively-charged substance that cultivates osteoconduction while preserving the polymer’s visualization, modulus and strength benefits. As spine companies seek alternatives to traditional PEEK, DiFusion President and CEO Derrick Johns says that the company merged the best qualities of titanium and PEEK to create ZFUSE. 

DiFusion Technologies recently invested $500,000 in a sheep study. They expect to submit the data to FDA in January 2018 as part of a 510(k) filing that, once cleared, would give the company osteoconductive and biological fixation claims for their material. No other company can make that claim, says Mr. Johns.

DiFusion Technologies, founded in 2010, describes itself as an advanced biomaterials manufacturer and not a device company. In 1H18, the company plans to seek a strategic partner for ZFUSE.

DiFusion’s patented process lends itself to development of bony ingrowth, antimicrobial and tissue regeneration polymers. CleanFuse material, an antimicrobial PEEK, has CE Mark approval, and the company plans to first launch it in U.S. hip and knee segments, where infection prevention is highly prevalent.

“We can also load strontium, magnesium and zinc into the same matrix and control how much is eluted,” Mr. Johns says. “Introducing other ions in this platform will be the future of tissue regeneration. For example, we can grow collagen on the surface of this plastic by loading it with copper; the collagen cells will attract and proliferate on the surface.”

Fountainhead Investment Partners
Brian Kieser, Managing Partner

Unique Device Identification (UDI) remains a critical pain point for many device companies. Fountainhead Investment Partners and its incubator Watershed Idea Foundry highlighted structural encoding technology that it plans to license to device companies as an alternative to sterile packaging or direct part marking. The technology is currently being used by Nvision, a Fountainhead portfolio company.

For spine devices, the company is “notching” or 3D barcoding tantalum markers. Should a doctor or patient need to find the implant’s unique device identifier, an x-ray can read the notches. This information is entered into the Implant ID app, which then provides the ID number, brand name, version, company name, etc.

Brian Kieser, Nvision Founder, Fountainhead Investment Managing Partner and entre-preneur behind the technology, says that FDA qualifies the technology as direct part marking.

The technology can be used in other applications: pedicle screws, hammertoe implants and even additively-manufactured products can include a barcoding sequence.

Mazor Robotics
Doron Dinstein, M.D., Chief Medical Officer

Interim study results have demonstrated that surgeries performed with Mazor Robotics’ Renaissance Guidance System, using Mazor Core technology, yielded a five-fold reduction in surgical complications and a seven-fold reduction in revisions vs. freehand-based, minimally invasive lumbar fusion.

MIS ReFRESH, initiated in 2014, is an ongoing prospective, multi-center study comparing use of Renaissance guidance to fluoroscopic-guided, freehand procedures. Of the 379 patients enrolled, 287 were in the robotic-guided arm and 92 in the fluoro-guided control arm. Interim data was prospectively collected by ten surgeons from nine U.S. sites. Mazor notes that this may be the first multi-center prospective study of robotic-guided spine surgery.

Mazor Core refers to the four technologies that back Renaissance and Mazor X systems, which are designed to support predictable, efficient and precise procedures. The four technologies address surgical planning, anatomy recognition, patient/machine connection and a registration tool that can analyze and match images from different modalities and body positions. Mazor leadership cites these four technologies as what sets their robot apart from others on the market or in development that are primarily navigation-based.

Doron Dinstein, M.D., Chief Medical Officer, says that robotics is impacting surgeons by allowing those who aren’t well-versed in minimally invasive surgery (MIS) to try the approach, or for those who use MIS for single-level cases to do larger constructs. “We’ve seen surgeons who don’t do minimally invasive move from completely open to completely MIS practices,” he says. “It’s a gateway to change your practice.”

Jodie Morrow, Communications Manager, Stryker Spine

Stryker’s focus at NASS was launch of the Tritanium C Anterior Cervical Cage and the Serrato pedicle screw.

The Tritanium C Anterior Cervical Cage was FDA-cleared in late 3Q17, and adds to the company’s line of highly-porous devices enabled by the AMagine additive manufacturing approach. Stryker launched the Tritanium PL Cage in 2016 and plans to launch a TL Cage in 2018, followed by expandable technology.

Tritanium has become a core brand in Stryker’s portfolio. The company’s continual investments and expertise, including those related to hip and knee, demonstrate that Stryker wants to own the additive manufacturing space in orthopaedics, says Jodie Morrow, Communications Manager.

Serrato pedicle screws, which received FDA 510(k) clearance in mid-2Q17, have been implanted by >100 U.S. surgeons during initial launch—ahead of full commercialization. The dual-thread screws with serrated flutes are designed to lower the amount of insertion torque required, and “True-Tip’ geometry is intended to support precise insertion. These features are intended to increase speed and enhance surgical efficiency.

On a final note, Stryker expects a Mako spine application update by NASS 2018.

Zimmer Biomet
Joe Ross, General Manager, Zimmer Biomet Spine

Zimmer Biomet leadership emphasized that the division has completed integration of its 2016 acquisitions of LDR and Medtech, whose products (Mobi-C artificial disc and the ROSA robot, respectively) were prominently showcased.

Zimmer Biomet has built a broad portfolio of differentiated products in recent years with artificial discs, robotics and now its NASS launch of Vitality+ and Vital spine fixation lines.

Vitality+ and Vital will serve as centerpiece technologies for the company’s thoracolumbar presence over the next decade. Vitality+ comprises Vitality+ POWER for controlled pedicle preparation and screw insertion, Vitality+ PSO for pedicle subtraction osteotomy and vertebral column resection, and Vitality+ HOOKS for additional fixation options. For degenerative thoracolumbar procedures, Vitality+ is available in a two-kit pedicle screw instrument configuration. Vital Spinal Fixation comes in a minimized, two-kit configuration with all instruments required for degenerative spine surgeries in a color-coded tray layout. Vital screws incorporate a T27 hexalobe drive feature designed to provide 30% more strength than the T25 hexalobe. Vital’s dual lead screws require a reduced number of revolutions for insertion, supporting surgical efficiency.

Regarding ROSA, the company has said little about the technology since its purchase. Zimmer Biomet is undergoing the 510(k) submission process and anticipates a launch for its spine applications next year. When asked what makes ROSA stand out in the market, Mr. Ross mentioned the company’s ability to leverage the robot across business units, such as knee.

Finally, when asked what stood out for him at NASS, Mr. Ross mentioned continued surgeon interest and confidence in cervical disc replacement.

As noted earlier, we realize this is a small sample size of voices from NASS. What were your takeaways?

Email them to Carolyn or Julie.