Optilume BPH System launches globally in the urology market

[madman]

Optilume BPH System officially launches on world urology market

The minimally invasive surgical therapy Optilume was recently approved by the FDA for the treatment of lower urinary tract symptoms secondary to BPH.

www.urologytimes.com

World's first use of Optilume BPH System, a minimally invasive therapy for lower urinary tract symptoms due to BPH, performed successfully. The system combines mechanical dilation with a drug-coated (paclitaxel) balloon for healing. Dean Elterman, MD, conducted the procedure at University Urology Associates in Toronto. Optilume BPH offers a promising option for men with LUTS caused by benign prostatic enlargement, providing symptomatic relief and improved quality of life.

FDA approved Optilume BPH Catheter System for LUTS secondary to BPH on June 30, 2023.




Key takeaways:

PINNACLE data​

• Optilume BPH System showed significant and immediate improvements in BPH patients at 12-month follow-up.
• IPSS score decreased by a median of 11.5 in the Optilume arm vs. 4.8 in the sham arm at 1 year (P <.001).
• The therapeutic response rate (≥30% improvement in IPSS) was 76.6% in the Optilume arm vs. 33.3% in the control arm at 12 months (P <.001).
• Patients experienced sustained improvement in IPSS over 1 year.
• The average peak urinary flow rate (Qmax) improved by 113% from baseline to 1 year, the highest reported in MIST trials for BPH.
• Post-void residual urine volume improved by 28% at 30 days and remained sustained through 12 months.

EVEREST data​

• EVEREST-1 trial presented 4-year data on Optilume BPH treatment's sustained efficacy and safety for LUTS in BPH patients.
• The trial enrolled 80 men with BPH across 6 centers, with 32 subjects having 4-year follow-up data.
• Peak urinary flow rate (Qmax) significantly improved from baseline to 14 days and was sustained at 4 years (18.8 mL/sec to 18.1 mL/sec, P <.001).
• IPSS and BPH-II symptom measures showed immediate and sustained improvement over 4 years (from 22.3 to 11.5 and from 6.9 to 3.9, respectively).
• Optilume BPH treatment showed sustained functional and symptomatic improvements over 4 years.
• The findings were reported in an abstract conclusion by Kaplan et al.

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[madman]

Optilume

The Optilume drug-coated balloon is an exciting innovation in urethral stricture treatment—giving patients and physicians an effective solution that can deliver sustained patency and long-term relief.

urotronic.com

Optilume BPH is a novel minimally invasive surgical therapy (MIST) that combines mechanical dilation with the delivery of paclitaxel for the treatment of lower urinary tract symptoms (LUTS) secondary to BPH. Mechanical dilation with Optilume BPH achieves an anterior commissurotomy separating the lateral lobes of the prostate, while the delivery of paclitaxel is intended to maintain luminal patency during healing.

Immediate symptomatic and functional improvements1,5

 

[madman]

Urotronic Announces Completion of the World’s First Optilume® BPH Catheter System Commercial Procedure in Toronto

benign prostatic hyperplasia (BPH), EVEREST trial, Optilume® BPH Catheter System, Urotronic, minimally invasive surgical therapy (MIST), lower urinary tract symptoms (LUTS), urethral strictures, PINNACLE trial.

www.urotoday.com

 

[madman]

Optilume BPH catheter system

The Optilume BPH Catheter System is a non-surgical treatment for benign prostatic hyperplasia (BPH) in aging men. It involves balloon dilation and localized transfer of paclitaxel to maintain patency. The procedure is performed using rigid cystoscopy in an office setting, without general...

www.excelmale.com

 

[madman]

Optilume BPH System demonstrates sustained improvements in LUTS secondary to BPH

"The next-generation Optilume BPH Catheter System offers a safe and effective new, minimally invasive treatment for BPH, reducing urinary obstruction with a low rate of sexual or other adverse effects," says Steven A. Kaplan, MD.

www.urologytimes.com