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.
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Learn more about Benign Prostatic Hyperplasia
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)
6 Months
12-month follow up
IPSS: 10.9
Qmax: 113% Improvement
Baseline
Baseline
IPSS: 23.4
Qmax: 8.9 mL/sec2
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| Catalogue Number | Description | Pre-dilation Catheter Size | DCB Catheter Size | Rated Burst Pressure (RBP) |
| 1189-30030 | Optilume® BPH Prostatic Dilation Kit (30 x 30mm) | 90 Fr x 30 mm | 90 Fr x 30 mm | 4 atm |
| 1189-30035 | Optilume® BPH Prostatic Dilation Kit (30 x 35mm) | 90 Fr x 30 mm | 90 Fr x 35 mm | 4 atm |
| 1189-30040 | Optilume® BPH Prostatic Dilation Kit (30 x 40mm) | 90 Fr x 30 mm | 90 Fr x 40 mm | 4 atm |
| 1189-30045 | Optilume® BPH Prostatic Dilation Kit (30 x 45mm) | 90 Fr x 30 mm | 90 Fr x 45 mm | 4 atm |
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. 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.
©2024 Laborie. All rights reserved.
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. 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.
©2024 Laborie. All rights reserved.
