The study objective is to evaluate the safety and feasibility of the Vivifi device to treat symptomatic, benign prostatic hyperplasia (BPH).
Male 45-80 years of age
Diagnosed with Benign prostatic hyperplasia (BPH)
Prostate volume: ≥ 40 ≤ 100 cc measured by MRI
Qmax ≤ 10 mL/s on two measures (voided volume ≥ 125 mL)
Patients with prior history of relevant scrotal or testicular vascular surgeries or procedures, or vasectomy.
Previous procedural prostate intervention (TURP, laser, ablation, prostate artery embolization, etc.). Prostate biopsies are acceptable
Intravesical prostatic protrusion (IPP) > 10 mm
Post-void residual volume (PVR) > 200ml
Vivifi Medical
Lead sponsor
RQM Plus
Collaborator