UroNav Availability in the USA
UroNav is manufactured and distributed by Philips Healthcare (Best, the Netherlands) and is commercially available in the United States through Philips' medical device distribution channels.
Product Information
UroNav is an electromagnetically (EM) tracked MRI/ultrasound fusion-guided biopsy platform specifically designed for prostate cancer detection 1, 2. The system enables both transperineal and transrectal approaches for targeted prostate biopsies 1, 2.
Clinical Performance
- Cancer Detection Efficacy: In a cohort of 176 patients, UroNav-guided transperineal targeted biopsy detected 90.4% of prostate cancer cases (122/135), with 76.3% being clinically significant disease 1
- Sensitivity: The platform demonstrated 90.4% sensitivity for cancer detection when used for transperineal targeted biopsy 1
- Safety Profile: No adverse events, including sepsis, were reported in clinical studies 1
Comparative Approach Performance
- Transperineal vs. Transrectal: In a prospective study of 379 patients, both transperineal (59% detection rate) and transrectal (54% detection rate) approaches using UroNav showed comparable detection of clinically significant prostate cancer, with no statistically significant difference (OR 0.94,95% CI 0.58-1.51, P = 0.791) 2
- Enhanced Detection: EM-tracked targeted biopsy enhanced the ability of systematic biopsy to detect prostate cancer, with greater sensitivity for clinically significant disease 1
Acquisition Pathway
To purchase or obtain information about UroNav in the USA, contact Philips Healthcare's medical device sales division directly, as this is a specialized medical imaging and intervention platform requiring institutional procurement rather than individual purchase 1, 2.