June 14, 2024—Swiss interventional radiology company Medical Templates has announced that its Cube Navigator System (CNS) software has received U.S. FDA approval for planning CT-guided percutaneous interventions.
The software was previously marketed in Europe, and following this FDA approval, it will continue to enter the U.S. market, expanding the treatment options in oncology.
Cube Navigator System
CT-guided interventions are typically done manually, and the accuracy of needle placement is crucial for success.
Inaccurate needle placement can lead to prolonged surgery time, excessive radiation exposure, adverse events, or failure, such as undiagnosed biopsy samples or insufficient treatment. The Cube Navigator System (CNS) is an innovative navigation system comprised of planning software and patented related Cube accessories, used for precise alignment of needles and other instruments in image-guided punctures. The planning software operates on a standard PACS viewer, can be installed on a PC in the CT room, and connects via a standard DICOM interface, compatible with every CT and PACS system. It features a virtual needle (shown as a yellow line in images) to plan interventions. Using the virtual pointer, built-in algorithms can calculate the best coordinates to use on the upper and lower template planes of the cube in real-time. Additionally, the software automatically corrects the needle path, placing the virtual needle's path into the corner of the hole, thus achieving stable and precise insertion of the puncture needle.
Cube Accessories Overview
Access Cube
Access Cube is the latest member of the Cube Navigation system, fully detachable, guiding up to 10G needles and thin instruments, thus usable for various minimally invasive interventions.
Complex procedures such as ablation, biopsy, and placement of drainage tubes, even with difficult trajectories, can be executed with high precision and planning reliability.
With a movable grid, Access Cube allows complete access to the intervention area, providing optimal control and functionality for the user.
Puncture Cube
Designed specifically for pain management interventions, it ensures effective pain treatment by precisely bringing the needle to the target injection site.
The Puncture Cube supports 18-22G needle sizes and is an easy-to-use needle alignment tool in CT-guided punctures.
Once the needle is firmly inserted, the Puncture Cube can be folded, allowing the intervener to make minor adjustments or reach deeper targets.
Workflow
Place the cube on the target area of the intervention, firmly fixed with an adhesive pad;
Use standard planning scans of the target area;
The software automatically detects the cube in the planning scan images;
Create a trajectory using the virtual pointer in the software, which calculates the best entry point on the cube to reach the target;
Follow the software-highlighted path to pass the needle through the holes on the upper and lower plates of the cube, then perform the puncture.
System Advantages
High precision: Accurate needle placement means shorter surgery times and lower risks of complications and adverse events. The use of CNS has been shown to improve accuracy for both single oblique and double oblique paths.
High efficiency: Since there is no setup or calibration time, using CNS does not add any extra time to the procedure. In fact, studies have shown that when CNS is used with the Puncture Cube or the Access Cube, the overall surgery time can be significantly reduced by 15-45%. Additionally, the variability in surgery time is smaller, making CT scheduling easier.
Less radiation: Inaccurate needle placement can lead to unnecessary radiation exposure.
Studies have shown that using CNS can reduce the number of control scans by improving the accuracy of interventions, especially for complex and double oblique punctures.
Besides, the system also has advantages of calibration-free and universal compatibility.
Research Data
The company cited a recent study that found that punctures performed using the Cube Navigation System compared to FHM:
Greater distance from the target at initial puncture (>4 times: 2.5mm ± 1.2mm vs. FHM 12.1mm vs. 7.7mm);
Significantly more accurate final puncture position (3.8mm ± 1.3mm vs. FHM 6.7mm ± 4.5mm, p=0.004);
Less time required for puncture (263.1 s ± 84.4 s vs. FHM 411.2 s ± 141.0 s);
Only half the time needed for control scans (1.4± 0.6 vs. FHM 2.8±0.4, p<0.001).
The study results by Lorenz Krammer et al. were published in a relevant journal, and currently, the company is conducting further studies on accuracy and speed in Switzerland and Germany.
About Medical Templates
Medical Templates was established in Switzerland in 2015, aiming to change the way thin instruments are used in image-guided interventions: making it safer for patients, easier for radiologists, and cost-effective for the healthcare system.
The company's Cube Navigator System has been approved in Europe and the US, including the Access Cube, which has been patented by the United States Patent and Trademark Office.
The board members include Alessandro Celli, Oliver Eckelmann, Francis, Aaron Berez, and John Frolich.
Oliver Eckelmann is a co-founder and CEO of multiple biotechnology companies and serves as the CEO of discoveric ag. Before entering the biotechnology startup field, he joined pharmaceutical company Roche in early 2006, holding increasingly important positions in control and planning. In 2009, he was appointed Vice President/Global Head of Strategy, Planning, and Special Projects in Basel, Switzerland, for Roche.
Francis is a global leader in the diagnostics, pharmaceutical, and laboratory industries, serving as the CEO of Skope, AG (a Canon Medical Systems company), and president of MR, inc. He joined the board in spring 2022, bringing extensive experience in integrated management, innovation, and strategic marketing.