6116 East Arbor Avenue, Building 2, Suite 108, Mesa, AZ 85206
6116 East Arbor Avenue, Building 2, Suite 108, Mesa, AZ 85206
Safe, Effective, and Durable BPH Relief
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) This minimally invasive surgical therapy combines mechanical dilation with concurrent localized delivery of paclitaxel for treating BPH. Mechanical dilation with the proprietary double-lobe balloon technology achieves an anterior commissurotomy (split) releasing the constricting lateral lobes, while the delivery of paclitaxel prevents re-fusion of the lobes and maintains patency during healing. No cutting. No heating. No burning. No lasering. No steaming. No implantation! Some Laborie products may not be available in certain regions. Please contact your local Laborie Sales Representative to learn more about the products available to you.
Safety profile in-line with existing BPH MISTs (1,2)
In the 4-year EVEREST trial and 12-month PINNACLE trial follow-up, there was:
• No impact on erectile and ejaculatory function (1,2)
The highest Qmax reported in BPH MIST trials to date (2)
Clinical results show long-lasting relief. (1,2)
The PINNACLE randomized control trial (2) shows excellent results through 1-year primary endpoint
follow up and is supported by the EVEREST feasibility study (1) showing sustained improvements up to 4
years(1)
and a low pharmacological and surgical retreatment rate. (1,2)
As men* age, it’s common to encounter prostate enlargement, leading to a condition known as benign prostatic hyperplasia (BPH). In fact, BPH affects 70% of men 60-69 years of age and 80% of those 70 years of age or older(1). The prostate surrounds the tube responsible for transporting urine and semen, know as the urethra. With BPH, as the prostate grows larger, it exerts pressure on the urethra, potentially causing interruptions in the natural flow of urine.
• Frequent trips to the bathroom, day and night
• Weak, slow or intermittent flow
• Urgent need to pee
• Inability to fully empty bladder
If any of these describe your condition, talk to a Healthcare Provider about your Lower Urinary Tract
Symptoms (LUTs). Some Laborie products may not be available in certain regions. Please contact your
Healthcare Provider to learn more about the products available to you.
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 (2) , Paclitaxel, into the open prostate.
When the drug coating is fully released, the balloon is deflated and removed. The drug prevents refusion of the lobes during healing, keeping the prostate open, restoring the flow of urine and relieving you of your bothersome symptoms.
No cutting. No heating. No burning. No lasering. No steaming. No implantation!
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 (3,4), 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.
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, or 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)5
*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.
*List of treatments is not all inclusive.
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