The Edison System for Treatment of Benign Prostatic Hyperplasia (BPH) Using Histotripsy
The purpose of this trial is to evaluate the safety of histotripsy using the HistoSonics Edison System for treatment of BPH.
• Subject is ≥ 50 years of age.
• Subject has signed the Ethics Committee (EC) approved trial Informed Consent Form (ICF) prior to any trial related tests/procedures and is willing to comply with trial procedures and required follow-up assessments.
• Subject is diagnosed with BPH.
• Subject has a Body Mass Index (BMI) \< 27.
• Subject has an I-PSS ≥ 15.
• Subject has a prostate volume \> 30 mL and ≤ 150 mL.
• Subject has a Qmax ≤ 15 mL/s with a voided volume of ≥ 125 mL during a uroflow test.
• Subject accepts the potential loss of ejaculatory function.
• Subject can tolerate general anesthesia. Index-Procedure Imaging Inclusion (Assessed day of procedure)
⁃ Subject has an adequate acoustic window to visualize the prostate using the HistoSonics Edison System.
⁃ Target treatment volume is ≥ 1 cm from the rectum as visualized on ultrasound, CT or MR imaging.