If PSA levels are high and diagnostic tests indicate an increased risk for prostate cancer, a doctor may recommend a biopsy to confirm a prostate cancer diagnosis. Prostate cancer is treatable, if properly diagnosed and staged, but the current standard of care, the trans-rectal ultrasound (TRUS) biopsy, has limited accuracy and can cause serious side effects.
To address these problems, Harmonus developed the ProBx System to be used for treatment planning and guidance for clinical, interventional, and diagnostic procedures of the prostate.
The objective of the ProBx System is to improve the precision of in-bore MRI-guided prostate interventions by providing procedure-specific software and a detailed record of sampling locations for continued surveillance and treatment.
The ProxBx System is designed to make the procedure as simple as possible. After the patient is scanned in the MRI, ProBx receives DICOM images from the scanner, leading the user through each step to add targets to patient scans.
The ProBx System provides grid coordinates and needle insertion depth for selected target(s), and assists physician confirmation of needle placement with feedback on the location relative to the target.
The single-use ProBx Grid and Calibrator Kit is designed to allow sampling of the entire prostate and facilitate accurate registration for improved targeting. The single-use ProBx Kits simplify patient set-up.
After the biopsy sample is taken, a report is generated with needle path tracing, sample identification and user notes.