Medical Templates has announced that they have received US Food and Drug Administration (FDA) clearance for their Cube Navigator software for planning of percutaneous, computed tomography (CT)-guided interventions.
Part of the Cube Navigation System, the computer vision-enabled software pairs with Medical Templates’ proprietary hardware, a needle guide in the form of a Cube, as an alternative to free-hand navigation as well as capital-intensive solutions such as robots. With adoption rapidly expanding in Europe, the FDA clearance dovetails with the launch of the product in the US market.
Navigation is gaining importance in the field of interventional radiology (IR), mainly driven by expanding treatment options in oncology and improved patient outcomes through the use of minimally-invasive procedures, the press release states. Smaller targets, more complex access routes, and time and personnel constraints have all contributed to the increased adoption of CT navigation systems.
“Market pressures are pushing physicians to perform increasingly complex procedures, while reimbursement continues to be a driving force in determining which tools are used during interventions. The Cube Navigation System was designed to provide accurate navigation at a reasonable price point, without compromising on workflow complexity or speed,” says CEO Anika Uhde. “Centres in Europe have been enthusiastic about our solution because of its ease of use and incredibly fast onboarding. They see an improvement almost immediately.”
A recent study published in the Journal of Vascular and Interventional Radiology (JVIR) found that punctures performed with the Cube Navigation System were more than 4x closer to the target on the initial puncture (2.5mm ± 1.2mm vs. FHM 12.1mm ± 7.7mm), had significantly more accurate final needle locations (3.8 mm ± 1.3 mm vs. FHM 6.7 mm ± 4.5 mm, p=0.004), and were significantly faster (263.1s ± 84.4s vs. FHM 411.2s ± 141.0s, p<0.001). Further studies on accuracy and speed are currently being carried out in Switzerland and Germany.
