Robotic systems would have undoubtedly received major play at the Annual Meeting. Numerous technologies from startup to mid-sized companies would have been on display in the exhibit hall—a departure from just a few years ago, when mainly the larger players were talking about these tools. These technologies, primarily in joint replacement and spine, span the continuum of care. Some are being developed and launched alongside dedicated implants and instruments, while others are standalone.
Along with a description of the technology, we pulled together recent strategic activity and development milestones to provide great insight.
LimaCorporate launched its first digital solution, Smart SPACE Shoulder Planner. The company completed the first total shoulder replacement using the application in early February.
The software uses a 3D patient-specific model derived from a CT-scan, and is compatible with Lima’s complete implant shoulder portfolio for a wide range of primary total shoulder replacement indications. The system is based on a proprietary machine-learning algorithm that draws from an extensive database of morphological data points to design surgical plans and 3D Positioner guides.
Currently, in limited market release, Smart SPACE Shoulder Planner will experience full launch within 2020.
The technology was developed by medical device software company TechMah Medical, which Lima acquired in 2018. FDA 510(k) clearance to market the Smart SPACE Shoulder 3D Planner & 3D Positioner was granted in late 2019.
Future releases of Smart SPACE will include intra-operative surgical guidance systems to simplify procedures and support personalized patient care. When fully launched, Smart SPACE will have application in shoulder, hip and knee replacement procedures.
Medacta received FDA 510(k) clearance to market MyShoulder Placement Guides for use with the Medacta Shoulder and associated instrumentation, reportedly the first patient-specific offering in the U.S. to provide both humeral and glenoid guides in the surgical plan. Detailed patient modeling, via CT imaging, supports precise reconstruction of patient bone morphology for a patient-matched fit.
Previously, Medacta launched shoulder placement guides in Japan in 2019. The company’s other personalized surgical approaches include MyKnee, MyHip and MySpine platforms.
Augmedics commenced U.S. launch of the xvision (XVS) augmented reality guidance system for spine surgery, following FDA 510(k) marketing clearance.
xvision Spine allows surgeons to visualize 3D spinal anatomy during surgery as if they had “x-ray vision,” and to navigate instruments and implants while looking directly at the patient, rather than a remote screen.
xvision comprises a transparent near-eye-display headset and all elements of traditional navigation. It determines the position of surgical tools in real time, then superimposes a virtual trajectory on the patient’s CT data. 3D navigation data is then projected onto the surgeon’s retina using the headset, allowing a simultaneous view of the data and the patient. The system’s small footprint, economical cost and compatibility with current instrumentation is designed to allow easy integration into any surgical facility.
Augmedics will explore additional applications for xvision beyond spinal surgery.
Insight Medical Systems conducted its first cadaveric evaluation of the ARVIS Augmented Reality Visualization and Information System, a personal, self-contained navigation system for hip and knee replacement. ARVIS, containing tracking cameras, 3D display, and handsfree interface, can be worn under a sterile hood. The system is used with a single tray of trackable instruments, ARVIS supplies the surgeon with key navigation data.
Surgeons achieved three landmark goals by navigating a distal femoral and tibial resection in a knee procedure, navigating an acetabular cup position according to their preferred approach and measuring leg length and joint offset.
Naviswiss is a navigated total hip replacement application that is image-free and provides the surgeon with accurate information on cup alignment, leg length and offset.
The company took numerous steps to build regulatory and market coverage of its miniaturized surgical navigation in late 2019 and early 2020.
The company raised CHF 5 million (USD $5 million) in a round of private equity funding to support product development and entrance into U.S. and Japanese markets. Naviswiss has established a U.S. office in Denver and is awaiting FDA clearance. In January 2020, the company said that it would enter the Japanese market, having received regulatory approval.
The application is open for all implant manufacturers and supports all surgical approaches. The technology has been CE Marked since 2018.
PERCEIVE3D (P3D) has developed video-based technology for surgical navigation that combines intelligent video processing for 3D mapping of the anatomy, with AR for overlaying meaningful guidance information in images. It is reportedly the first system of its kind to provide higher metric accuracy while solving the problems of ergonomics and economics, and the first effective solution for navigation in arthroscopy that uses video acquired by the already-employed arthroscopic camera.
The company was granted two additional patents to protect its surgical navigation technology that combines video-based tracking with AR to provide guidance in arthroscopy and open orthopedic surgery.
P3D has been evaluated in a knee arthroplasty cadaver test using software run on a mobile phone, as well as a new version of the navigation software for arthroscopic surgery.
Regulatory submissions will occur during 2020, with a goal of commercial launch in 2021.
OrthoSensor and McLaren Applied formed the startup EnMovi to expand development of MOTIONSENSE wearable smart sensor technology and ORTHOLOGIQ data analytics for use in orthopedic patient care.
The venture pairs OrthoSensor’s years of experience in intelligent sensor-assisted technology with McLaren’s Formula 1-derived insights into applications for software, sensor technology, predictive analytics and design.
Specifically, OrthoSensor’s expertise in quantifying orthopedic data through sensor-assisted technology allows healthcare providers to deliver evidence-based treatments to improve clinical and economic outcomes.
With the support of McLaren’s quantifiable technology and machine learning capabilities, the new venture will develop MOTIONSENSE and ORTHOLOGIQ to monitor a patient’s care path pre-, intra- and post-operatively.