Every year the last week in September proves to be one of the most exciting (and exhausting) weeks in medtech. It’s during that week that our attention is split between three major conferences all happening at once. There’s always a flurry of product launches, clinical data readouts, company updates, and other breaking news coming out of these events, but this year seemed to be even more fast-paced than usual.
MD+DI recently highlighted the biggest developments from TCT 2019 so now it’s time to shine a spotlight on some of the coolest spine technologies we saw at the North American Spine Society (NASS) meeting (shown in alphabetical order by company name).
Benvenue Medical’s Luna Data
Santa Clara, CA-based Benvenue Medical released data to support its Luna expandable transforaminal lumbar interbody fusion cage.
The clinical results showed improved back and leg pain relief and lowered Oswestry Disability Index scores 12 months post-operation with the Luna cage. Single-center data from 47 consecutive MIS TLIF patients showed that lordosis was maintained or improved equally using the Luna lordotic and parallel cages. Back pain and leg pain were equally relieved using both cages and had a fusion rate of 95%.
“The Luna data shows an excellent correction of disc space height and foraminal height,” said Richard Fessler, MD, who completed the study and presented the data at NASS. “There was a strong correlation between that correction and clinical outcomes. It’s the most exciting interbody device that I’ve seen in my career – it can be put in through a TLIF exposure but expands into ALIF coverage. It achieves both of my surgical goals of being minimally invasive and offering maximal coverage.”
The Luna system is a small, multi-expandable interbody fusion device that uses ALIF principles with a controlled posterior approach to provide anterior column stability, strength and fusion support in patients who have symptomatic degenerative disc disease.
Brainlab’s Loop-X Imaging Robot
Munich, Germany-based Brainlab unveiled its Loop-X intraoperative imaging robot at NASS 2019. The company touted that its Loop-X robotic architecture introduces a new standard in flexibility, adding additional degrees of freedom to any surgical procedure. The system is designed to automate imaging workflow steps. By robotically moving with the procedure and on command, the system is in sync with other devices like robotic arms and with the surgeon and staff, the company said. The non-isocentric movement and collimation capabilities allow for the imaging of structures that are much larger—for example in diameter—and much smaller—reducing radiation exposure—than what is possible with the typical CT or 3D C-arm. The highly integrated device is designed for 2D and 3D imaging, combining ultra-high resolution with extra-low doses, and proprietary technology to image with interlaced energies for soft-tissue visualization. Loop-X imaging robot can be integrated with Brainlab technology as well as third party products through an open interface, maximizing interoperability, and data integration.
“For Brainlab, Loop-X is a critical milestone in contributing disruptive innovations in spinal surgery,” said Stefan Vilsmeier, the company’s president and CEO. “It provides us with an even stronger foundation for leveraging emerging technologies such as AI, big data, cloud computing, augmented reality, and spatial computing.”
Beyond diagnostic imaging, the intelligent device can capture partial information, “digitizing” anatomical intraoperative changes in order to update a digital model of the patient previously generated by aggregating pre-operative images.
Loop-X imaging robot has been developed by medPhoton in close partnership with Brainlab. Brainlab has co-funded development, strategically invested in the Salzburg-based company, and become the exclusive distributor of Loop-X imaging robot in surgery, underscoring the company’s commitment to innovation. We wouldn’t be surprised if we saw a merger between the two companies, given that Brainlab acknowledged the two have already agreed upon a path forward toward further deepening the collaboration and integrating their activities in the future.
Life Spine’s Prolift Lateral Expandable Spacer System
Huntley, IL-based Life Spine touted the initial surgeries of its Prolift Lateral expandable spacer system. Prolift Lateral was designed to assist in the restoration and maintenance of sagittal alignment with multiple lordotic options of 0°, 7°, and 15°; as well as meeting patient sizing requirements by offering footprints of 18mm, 22mm, and 26mm wide; heights ranging from 8mm-20mm; and lengths from 45mm to 60mm. In-situ delivery of graft material after final expansion can be accomplished with the company’s Osteo-Line graft delivery device, designed to assist in the fusion process.
MD+DI got an up-close look at a Titan Spine Interbody Device (shown above) at NASS.
Medtronic’s Recently-Acquired Titan Spine Interbody Devices
Medtronic launched several new procedural solutions for spine surgery at NASS, all of which are part of the company’s Surgical Synergy platform, which integrates technologies with the goal of creating consistent, predictable, and reproducible spine procedures.
The company seemed particularly excited to show off its recently acquired Titan Spine interbody devices with FiberCel viable bone matrix (VBM) combines Titan nanoLOCK surface technology, which increases cellular factors related to bone growth and anti-inflammation, with FiberCel VBM.
“Surgeons are very interested in titanium,” William Albans, senior marketing director for Medtronic’s spine and biologics business told MD+DI at NASS.
What made Titan’s interbody devices attractive to Medtronic is the microsurface nanotechnology aspect, not to mention all the data and experience that Titan had to support the platform technology.
“What we were looking for was not just a titanium cage,” Albans said. “We wanted something that was validated with clinical evidence and the nanotechnology does that.”
Another bonus is that the Titan nanoLOCK surface technology is already offered across seven different interbody platforms to meet a variety of procedural needs.
“This nanotechnology is a technology we can apply across our portfolio,” Dave Anderson, VP, and general manager of enabling technologies at Medtronic, told MD+DI. “So we’re buying a specific interbody but at the same time we’re also buying a platform technology.”
Also at NASS, Medtronic showcased:
- SynergyCorpectomy, a fully-navigated corpectomy system. The workflows feature Medtronic’s new, expandable T2 Stratosphere implant, Grafton DBM DBF, and the newly-launched Midas Rex MR8 System. It is integrated with O-arm imaging and Stealth software to enable pre-surgical planning, real-time navigation, and multiple benefits including virtual sizing of the implant, 3D implant placement visualization, and confirmation of implant placement when using a Surgical Synergy workflow.
- SynergyOLIF360SM single-position workflow is differentiated with Infuse bone graft as well as the combination of Medtronic’s O-Arm imaging and Stealth software. Integrated technologies enable the entire oblique lateral interbody fusion procedure to be performed while the patient is on his or her side, eliminating the time and cost associated with mid-procedure repositioning.
- Midas Rex MR8 high-speed drill system during NASS. It is an eighth-generation drill system designed to deliver controlled precision, versatile access, and compatibility with Stealth to seamlessly integrate with Medtronic’s spine technologies.
NuVasive’s Pulse Robotics Application
San Diego, CA-based NuVasive’s Pulse system integrates multiple technologies in a single expandable platform designed for all spine procedures. As part of the platform, the company unveiled Pulse Robotics at NASS, an application intended to introduce automation while maintaining surgeon control to optimize clinical decision making and deliver better patient outcomes.
NuVasive’s booth also featured the X360 system, a comprehensive approach to lateral single-position surgery, powered by the Pulse platform. The Company also showcased its comprehensive Advanced Materials Science implant portfolio, which now includes cervical offerings and a full portfolio for all TLIF procedures, and Reline fixation system updates along with other procedural technologies.
Stryker’s SpineJack System
Kalamazoo, MI-based Stryker published SAKOS pivotal trial results for the SpineJack implantable fracture reduction system in The Spine Journal. The SAKOS trial was a prospective, multicenter, randomized study designed to support a non-inferiority finding for use of the SpineJack system versus balloon kyphoplasty (BKP) in the treatment of painful osteoporotic vertebral compression fractures (VCF). Based upon these study results, the SpineJack system demonstrated non-inferiority to BKP with an excellent risk/benefit profile for up to 12 months. This trial further provided compelling evidence to establish the superiority of the SpineJack system over BKP with regards to absence of adjacent level fractures and midline vertebral body height restoration at both 6 and 12 months after the procedure.
For over 35 years, osteoporotic VCF treatment has primarily focused on pain management, Stryker noted, adding that traditional fracture treatments have overlooked reduction, fixation, and restoration due to the limits of the instrumentation. “The SpineJack finally gives physicians the tools to take control of the procedure, restore the anatomy and reduce the possibility of future adjacent level fractures in patients,” Stryker said in a news release.
The surgical technique involves a short series of minimally invasive steps performed via a bipedicular approach. Using X-ray guidance, two expandable implants are inserted into the fractured vertebrae through small incisions. The implants are then expanded, restoring the vertebral anatomy and creating a cavity supported by the expanded titanium structure. The area surrounding the implants is then filled with bone cement to stabilize the fracture. As it hardens, the bone cement forms an internal cast that holds the vertebra in place. Following the procedure, most incisions are simply covered with bandages.
The SpineJack system, which expands Stryker’s already best-in-class VCF treatment portfolio, has been commercially available in Europe since 2010, with more than 70,000 units implanted in patients worldwide. The system received FDA 510k clearance on August 30, 2018. In addition to the AutoPlex cement mixer and delivery system, the iVAS Elite balloon system, and the AVAflex curved balloon system, the SpineJack system provides physicians the flexibility to customize their VCF treatment approach for each individual patient in an effort to generate the best outcomes possible. The SAKOS study can be found (here). For more information about the SpineJack system, please visit Stryker at booth number 4011 at the NASS annual meeting.
TheraCell’s Demineralized Bone Fiber Anchor
Los Angeles, CA-based TheraCell launched a demineralized bone fiber bone anchor at NASS. The company describes the product as working much like a drywall anchor and provides immediate improvement in screw fixation in primary and revision cases.
The TheraFuze DBF fiber anchor is made entirely from the company’s demineralized cortical bone fibers. Testing has demonstrated it more than doubles the pullout force versus screws without the fiber anchor and testing in a model of revision surgery demonstrated that it restores or improves on the original pullout force without having to increase hole size or use any other materials. Anchors are initially sized to be used with 5.5, 6.5 and 7.5mm screws.|
Original Article: (https://www.mddionline.com/8-hottest-takeaways-nass-2019)