The main goal of this study is to evaluate the ALPFA GRAIL™ Pulsed Field Ablation (PFA) System for treatment of enlarged prostate (BPH) symptoms. The study will involve up to 250 male participants who have urinary problems caused by BPH and whom are greater than 40 years of age in up to 30 investigational centers across the US,Canada and European Union.
≥ 45 years of age on the day of enrollment.
Symptom Score: Baseline IPSS score ≥13
Flow Rate: Single uroflow test with a minimum voided volume ≥ 125 mL and a Qmax ≥ 5 mL/sec and ≤ 12 mL/s
Residual: ultrasound-determined PVR of ≤ 250 mL
History of clinically significant heart failure (NYHA III/IV)
Uncontrolled arrhythmia.
Stroke, TIA, myocardial infarction, unstable angina, percutaneous coronary intervention, or any cardiac surgery within 180 days of enrollment.
Uncontrolled hypertension