Optilume® BPH Catheter System
Safe, Effective, and Durable Minimally Invasive BPH Treatment. Introducing the next-generation of minimally invasive BPH treatment.
Safe, Effective, and Durable Minimally Invasive BPH Treatment. Introducing the next-generation of minimally invasive BPH treatment.
The Optilume® BPH Catheter System revolutionizes the treatment paradigm by providing immediate and durable symptom relief for men* experiencing BPH induced lower urinary tract symptoms. (1,2)
Read More…
Custom sizing to individual patient prostatic anatomy
for optimal outcomes.
Transurethral delivery of the Optilume® BPH semicompliant drug coated balloon to the enlarged prostate.
Inflation of the drug coated balloon, creates an anterior commissurotomy (split) and concurrently delivers an anti-mitotic pharmaceutical agent, paclitaxel.
A foley catheter is placed for a minimum of 2 days allowing adequate healing of the prostate, and absorption of paclitaxel.
Baseline: IPSS 23.4 and Qmax 8.9 mL/sec². At 6 months, through 2-year follow-up, measurements improved to IPSS 11.0 and Qmax 19 mL/sec².
113%
Improvement in Qmax 1
53%
Decrease in IPSS 1
20%
Decrease in PVR 1
Have questions about Optilume®? Speak with a real person or
email our team directly.
1. Kaplan SA. Interim 5-Year Outcomes After Treatment with a Novel Minimally Invasive Drug/Device Product. J Urol2024;211(5S):e426 doi:10.1097/AOG.0000000000004138
2. Kaplan, S.A., Moss, J.L. & Freedman, S.J. Two-year long-term follow-up of treatment with the Optilume BPH catheter system in a randomized controlled trial for benign prostatic hyperplasia (The PINNACLE Study). Prostate Cancer Prostatic Dis(2024). https://doi.org/10.1038/s41391-024-00833-z
3. The Optilume BPH Catheter System Instructions For Use, 1124-004 rA
The Optilume BPH Catheter System is indicated for the treatment of obstructive urinary symptoms associated with Benign Prostatic Hyperplasia (BPH) in men ≥ 50 years of age. The Optilume BPH Catheter System is contraindicated for use in: Patients with known hypersensitivity to paclitaxel or structurally related compounds, patients with an active urinary tract infection, patients with an artificial urinary sphincter, patients with a penile prosthesis. The Optilume BPH DCB contains paclitaxel, a known genotoxic aneugen capable of causing chromosomal abnormalities in sperm. Paclitaxel is present in semen for an extended duration after treatment with Optilume BPH. The risks associated with these paclitaxel concentrations in semen are unknown. The effect of treatment with the Optilume BPH DCB on sperm and spermatogenesis is also unknown. Men should abstain from sex or use barrier contraception (wear a condom) for 30 days post treatment to avoid exposure of sexual partner to paclitaxel. Paclitaxel may still be present at low levels after 30 days. Potential adverse effects after treatment with the Optilume BPH Catheter System are similar to standard cystoscopic procedures and mechanical dilation and include, but are not limited to fever, bleeding, pain, urinary tract infection, false route of the urethra, dysuria, difficult urination, frequency/urgency/irritative urinary symptoms, urinary retention and related symptoms, blood in urine (hematuria), urinary incontinence, urethrorrhagia, blood in semen (hematospermia), ejaculatory dysfunction, bladder perforation, urethral and/or bladder neck strictures, injury or perforation to the urethra, sphincter or prostatic capsule, and inflammation of genitourinary system (prostatitis, orchitis, balanitis).3
*Trans-women, with or without gender reassignment, may have a prostate. If BPH is diagnosed in a trans-woman, this is managed in the same way as for cisgender men.
MKT-00660 [A]
