Optilume® BPH Catheter System

Restore your flow and reclaim your life

with a bph treatment that provides immediate and durable relief

What is BPH?

As men* age, it’s common to encounter prostate enlargement, a condition known as benign prostatic hyperplasia (BPH). BPH is considered a common benign urological condition and although unrelated to prostate cancer, it can greatly affect quality of life. In fact, BPH affects 70% of men 60-69 years of age and 80% of those 70 years of age or older3. The prostate surrounds the tube responsible for transporting urine and semen, known as the urethra. As the prostate enlarges, it exerts pressure on the urethra, causing interruptions in the natural flow of urine.

Are BPH symptoms disrupting your way of life?

• Frequent trips to the bathroom, day and night
• Weak, slow, or intermittent flow
• Urgent need to pee
• Inability to fully empty bladder

Choose the Optilume® BPH Catheter System
for immediate and durable results

  • Clinical studies show Optilume®BPH is safe and effective 1,2
  • Immediate and durable symptom relief 1,2
  • Minimal catheter time 1,2
  • No impact on sexual function 1,2
  • Quick recovery 1,2
  • Highest clinically reported flow rates of any minimal invasive therapy 2
  • In-office/outpatient procedure
  • No cutting, heating, burning, lasering, steaming, or implantation

What is the Optilume® BPH Catheter System,
and how is it used?

Typically administered as an outpatient procedure, Optilume® BPH is a drug-coated balloon that is inserted into the urethra via a telescopic camera, to the prostate.

Once in the prostate, the balloon expands creating an opening, and releases the safe and proven drug 5, paclitaxel, into the open prostate.

When the drug coating is fully released, the balloon is deflated and removed. The applied drug prevents re-fusion of the lobes during healing, keeping the prostate open, restoring the flow of urine and relieving you of your bothersome symptoms.

Take control of your bph symptoms and
get back to doing the activities you love!

Revolutionizing the treatment of BPH, the Optilume® BPH Catheter System is a minimally invasive procedure with quick recovery time, and immediate symptom relief that is durable. 1,2

By combining mechanical dilation of the prostate with concurrent delivery of an anti-mitotic pharmaceutical agent, paclitaxel, your physician can effectively target and treat the cause of your BPH symptoms.

After the Optilume® BPH procedure, you will notice an immediate improvement in both urinary symptoms and quality of life, including improved urinary flow and the ability to happily relieve your bladder. Clinical studies show significant and durable improvements, 1,2 allowing you to reclaim control of your urinary system.

Discover the difference Optilume® BPH can make in restoring your quality of life.

Ask your doctor about Optilume® BPH today.

1. Kaplan, Steven; Pichardo, Merycarla; Rijo, Edwin; Lay, Ramon Rodriguez; Espino, Gustavo; Estrella, Rafael MP76-02 AT 4 YEARS, OPTILUME BPH HAS THE HIGHEST SUSTAINED IMPROVEMENT IN PEAK FLOW (QMAX) OF ANY MINIMALLY INVASIVE BPH THERAPY, Journal of Urology: April 2023 – Volume 209 – Issue Supplement 4, doi: 10.1097/JU.0000000000003350.02

2. Kaplan, Steven A.*; Moss, Jared; Freedman, Sheldon; Coutinho, Karl; Wu, Ning; Efros, Mitchell; Elterman, Dean; D’Anna, Richard; Padron, Osvaldo; Robertson, Kaiser J.; Lawindy, Samuel; Mistry, Sandeep; Shore, Neal; Spier, Jeffrey; Kaminetsky, Jed; Mazzarella, Brian; Cahn, David; Jalkut, Mark; Te, Alexis The PINNACLE Study: A Doubleblind, Randomized, Sham-controlled Study Evaluating the Optilume BPH Catheter System for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia, Journal of Urology: September 2023 – Volume 210 – Issue 3, doi: 10.1097/JU.0000000000003568

3. Berry SJ, Coffey DS, Walsh PC, Ewing LL. The development of human benign prostatic hyperplasia with age. J Ural. 1984 Sep;132(3):474-9. doi: 10.1016/s0022-5347(17)49698-4. PMID: 6206240.

4. The Optilume BPH Catheter System Instructions For Use, 1124-004 rA

5. Karnath KR, Barry JJ, Miller KM. The Taxus'” drug-eluting stent: a new paradigm in controlled drug delivery. Adv Drug Deliv Rev 2006;58:412-36

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.

Optilume® BPH post-procedure
patient care instructions