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Advances in implants and instrumentation are complemented by more and more digital tools to improve workflows and patient outcomes. Brainlab, Epica and Onkos Surgical recently launched products and announced FDA 501(k) clearances that prioritize imaging and surgical planning.
Brainlab’s Loop-X Automates Imaging
Brainlab has unveiled Loop-X™ (pictured above), reportedly the first mobile intraoperative imaging robot, designed for use in all spine procedures.
Loop-X robotic architecture automates imaging workflow steps and robotically moves with the procedure and on command, in sync with robotic arms and the surgeon/staff. It supports the imaging of structures that are much larger (e.g. in diameter) and much smaller, reducing radiation exposure vs. typical CT or 3D C-arms. The device provides 2D and 3D imaging in ultra-high resolution with extra-low doses. The imaging robot can be used with Brainlab technology or third-party products through an open interface.
Its compact footprint enables a simplified fit into existing surgical suites, and a wireless tablet eliminates the monitor cart and brings control to the sterile field.
Loop-X technology complements Elements Surgical Planning, Curve and Kick navigation and Cirq Robotics, the latter of which recently received FDA 510(k) clearance for use in spinal applications. The Cirq surgical robot is designed to optimize spinal fusion by freeing up the surgeon’s hands during procedures.
Epica Combines CT, Fluoroscopy and Digital Radiography
Epica was granted FDA 510(k) clearance to market the SeeFactorCT3™ Imaging Platform. SeeFactorCT3 comprises computed tomography (CT), fluoroscopy and digital radiography in one system. Having obtained FDA clearance, the company will now focus on development of a medical robot to integrate with CT imaging. The connection would allow the robot to be guided by SeeFactorCT3’s ultra-high resolution images.
The diagnostic, interventional and intraoperative imaging system can obtain ultra high-resolution 3D volumetric images throughout the body, and can serve as a primary imaging modality for practically all musculoskeletal applications.
SeeFactorCT3 features a detachable patient table/chair with a sterile drape for interventional procedures. The system is lightweight and maneuverable, and is suitable not only for imaging or operating rooms, but also ambulatory/outpatient centers and emergency rooms.
Onkos, 3D Systems Launch Surgical Planning System
Onkos Surgical launched the My3D™ Personalized Solutions platform, powered by 3D Systems’ VSP® (Virtual Surgical Planning) Orthopaedics. The companies partnered in 2018 on a four-year agreement to develop patient-specific tools for use in tumor reconstruction in the pelvis and long bones. This is their first product released.
VSP Orthopaedics enables 3D visualization of a patient’s anatomy to develop a highly personalized surgical plan, prior to surgery. The use of a patient’s own CT imaging to drive digital planning avoids the need for costly navigation or robots. My3D allows the surgeon to plan a tumor resection with a high level of precision that may preserve native joint function, instead of replacing the entire joint.
The process begins with collaboration. After a preoperative online planning session between 3D Systems’ biomedical engineers and the surgeon, patient-specific models, surgical tools and resection instruments are designed and 3D-printed for use within the sterile field. In clinical applications where VSP has been used, the tools have been shown to improve surgical accuracy and outcomes, thus saving time in the O.R. to the benefit of both surgeon and patient.
Onkos seeks to advance musculoskeletal oncologic care through personalization, reduction of complexity and addressing clinical challenges that are specific to tumor and complex revision surgeries.
