Biobot Surgical has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its new robotic-assisted transperineal needle-guidance system for prostate biopsy and cancer ablations.
The company said urologists can use its new iSR’obot Mona Lisa 2.0 system to plan and position a single needle or multiple needles during image-guided diagnostic and interventional prostate procedures.
Forming part of the Biobot Surgical’s iSR’obot Mona Lisa product portfolio, the iSR’obot Mona Lisa 2.0 system automatically facilitates needle positioning during transperineal prostate biopsy and prostate cancer ablation depending upon a customised needle plan.
The new system consists of a detachable needle guide that can hold a biopsy needle or multiple ablation needles.
Its other features include visualisation and planning of the needle locations for a prostate cancer ablation procedure, as well as the ability to re-adjust a target location when the needle deflects.
Biobot Surgical CEO Sim Kok Hwee said: “The Mona Lisa system was conceptualized and engineered to position biopsy or treatment needles transperineally. The advantages of transperineal procedures are lower infection rates and better coverage of the anterior zone compared to transrectal procedures.
“In addition, most ablation procedures are also carried out transperineally. The Mona Lisa system simplifies needle positioning by providing robotic-assisted guidance for the insertion.”
The second-generation iSR’obot Mona Lisa system is said to retain the MR-ultrasound image-fusion prostate biopsy technology.
The dual-cone needle trajectory technology of the robotic system will help extract multiple biopsy cores through the same needle entry points.
Biobot Surgical is selling the first-generation iSR’obot Mona Lisa in Europe, Australia, and Asia.
According to the company, clinical studies have shown that iSR’obot Mona Lisa has a clinically significant prostate cancer detection rate of 81% higher than cognitive fusion biopsy.
