(UroToday.com) During the annual Engineering and Urology Society (EUS) Meeting, Dr. Andreas Forsvall presented his award-winning poster on his novel biopsy needle, the Forsvall needle. Traditional biopsy methods rely on the Tru-cut needle, originally patented in 1969, which was not designed with modern infection control or MRI-targeted biopsy precision in mind. Herein, this study evaluates the performance of his newly designed needle in reducing bacterial transfer and improving target accuracy.
The study included three key components: 1) a randomized blinded ex vivo bacterial transfer study comparing bacterial spread across human colon tissue with Forsvall versus Tru-cut needles, 2) an in vitro gel-based simulation evaluating needle deviation and tissue collection during transrectal (TR) and transperineal (TP) biopsies, and 3) a clinical trial of 249 TR biopsies in 20 patients comparing biopsy length and patient experience (Figures 2 & 3).
Results from the ex vivo study demonstrated a 96% reduction in bacterial transfer with the Forsvall needle compared to Tru-cut (95% CI: 93.0–97.7%; p < 0.001), regardless of bacterial load. The Forsvall needle's enlarged head, along with its completely smooth and closed design, minimized bacterial trapping, unlike the Tru-cut needle, which harbored fecal matter between its components (Figure 3).
Figure 3. Factors that influence deviation between Forsvall and Tru-cut needles, denoted by red arrows
In the gel-based model, the Forsvall needle exhibited significantly less deviation and better target lesion sampling in both TP and TR simulations (p < 0.001 vs Tru-cut), achieving a 100% rate of target biopsies collected versus 4% for Tru-cut (Table 1).
Table 1. The Forsvall needle has better target collection and accuracy, and less deviation than Tru-cut.
*p < 0.001 vs Tru-cut.
Clinical trial results confirmed that the Forsvall needle was noninferior to the Tru-cut needle with respect to biopsy length and patient experience, supporting its clinical applicability.
Dr. Forsvall concluded that biopsy needle design is a critical factor in both infection control and precision targeting. The Forsvall needle’s significant reduction in bacterial transfer and improved sampling accuracy could challenge longstanding assumptions around the necessity of TP over TR biopsy routes. Ongoing and future clinical studies will further investigate how these improvements may influence infection rates and cancer detection outcomes.
Presented by: Andreas Forsvall, MD, PhD, Lund University, Helsingborg Hospital, and XAGA Surgical AB, Sweden.
Written by: Yezan Hadidi, BS, Department of Urology, University of California, Irvine. @yezanhadidi on X during the American Urological Association's 2025 Annual Meeting, between April 26 – 29, 2025, in Las Vegas, NV.