Optilume BPH System officially launches on world urology market

The world’s first patient in a commercial setting has been treated with the Optilume BPH System, a minimally invasive surgical therapy (MIST) used for the treatment of lower urinary tract symptoms (LUTS) secondary to BPH.¹

According to Urotronic, the developer of the treatment, the procedure was performed by Dean Elterman, MD, a urologist at University Urology Associates in Toronto, Canada.

Findings from the 12-month follow-up of the PINNACLE study presented by Steven A. Kaplan, MD, at the 2023 AUA Annual Meeting showed that treatment with the Optilume BPH System resulted in significant, immediate symptomatic and functional improvements in patients with BPH.

The Optilume BPH System is a MIST consisting of a drug-coated (paclitaxel) balloon system. “Mechanical dilation with [the system] achieves an anterior commissurotomy, while delivery of paclitaxel is intended to maintain luminal patency during healing,” Urotronic explained in a recent press release.²

"We are proud at University Urology Associates to be pioneering this novel, minimally invasive technology. The procedure was a success and was completed as planned under conscious sedation with the patient leaving our clinic the same day," Elterman said in a statement.¹ "The patient had a history of problematic urinary symptoms caused by benign prostatic enlargement and Optilume BPH represented a suitable option offering symptomatic and functional relief via a minimally invasive treatment method. Optilume BPH provides a new standard of care to improve the quality of life for millions of men suffering from LUTS caused by BPH."

FDA approval

In the United States, the Optilume BPH Catheter System was approved by the FDA on June 30, 2023, for the treatment of patients with LUTS secondary to BPH.² The approval was supported by data from the PINNACLE and EVEREST trials.

PINNACLE data

Findings from the 12-month follow-up of the PINNACLE study presented by Steven A. Kaplan, MD, at the 2023 AUA Annual Meeting showed that treatment with the Optilume BPH System resulted in significant, immediate symptomatic and functional improvements in patients with BPH.³

At 1 year, IPSS score was decreased by a median of 11.5 in the Optilume arm vs a median of 4.8 in the sham arm. The difference was statistically significant (P <.001). Also at 12-months, the therapeutic response rate, defined as the proportion of patients with a ≥30% improvement in IPSS, was 76.6% in the Optilume arm vs 33.3% in the control arm (P <.001).

“Patients in the Optilume arm showed an immediate and sustained improvement in IPSS over the course of 1 year, as compared to the sham arm,” Kaplan, a professor of Urology at the Icahn School of Medicine at Mount Sinai, said when presenting the findings at the AUA meeting. “There was also no perceived change in erectile or ejaculatory function after treatment as measured by IIEF and MSHQ-EjD.

The prospective, double-blind, sham-controlled PINNACLE study enrolled 148 patients with BPH at 18 centers in the United States and Canada. Patients were randomized in a 2:1 ratio to Optilume (n = 100) or sham (n = 48). Patients were not eligible if they had received prior surgery/MIST therapy.

The average peak urinary flow rate, or Qmax, improved from 8.9 mL/sec at baseline to 19.0 mL/sec at 1 year, translating to a 113% improvement. Kaplan said this is the “highest average peak urinary flow rate (Qmax) at 12 months reported in randomized MIST trials for BPH.”

He added that, “Post-void residual urine volume improved 28% from baseline to 30 days in the Optilume group, and this improvement was sustained through 12 months.”

EVEREST data

Kaplan also presented 4-year data from the single-arm EVEREST-1 trial at the 2023 AUA Annual Meeting. These findings showed sustained efficacy and safety with the Optilume drug-coated balloon catheter system in patients with LUTS related to BPH.⁴

Overall, the EVEREST-1 trial enrolled 80 men with BPH across 6 centers. Follow-up for the trial remains ongoing. At the time of the analysis, 4-year follow-up data were available for 32 subjects, with an additional 40 subjects still expected to have this long-term data.

According to Kaplan et al there was immediate functional improvement as measured by peak urinary flow rate (Qmax): at 14 days, Qmax data showed an increase from 10.9 mL/sec at baseline to 18.8 mL/sec. And at 4 years post-treatment, this improvement was sustained at 18.1 mL/second (P <.001 vs baseline).

The symptom measures IPSS and BPH-II also showed immediate and sustained improvement with Optilume. The mean IPSS at baseline was 22.3, compared with 11.5 at 4 years. The mean BPH-II was 6.9 at baseline and 3.9 at 4 years.

“The functional and symptomatic improvements seen after treatment with Optilume BPH have been sustained through 4 years in this early feasibility study,” Kaplan et al wrote in their abstract conclusion.

References

1. Urotronic Announces Completion of the World's First Optilume® BPH Catheter System Commercial Procedure in Toronto. Published online and accessed July 18, 2023. https://www.prnewswire.com/news-releases/urotronic-announces-completion-of-the-worlds-first-optilume-bph-catheter-system-commercial-procedure-in-toronto-301879774.html

2. Urotronic Announces FDA Approval of Optilume® BPH Catheter System, Pioneering the Next Generation of Minimally Invasive Solutions for Enlarged Prostate Symptom Relief. Published online and accessed July 11, 2023. https://www.prnewswire.com/news-releases/urotronic-announces-fda-approval-of-optilume-bph-catheter-system-pioneering-the-next-generation-of-minimally-invasive-solutions-for-enlarged-prostate-symptom-relief-301874287.html

3. Kaplan SA, Moss J, Freedman S, et al. 12-month outcomes from a randomized, sham controlled study evaluating a novel drug coated balloon for the treatment of BPH. 2023 AUA Annual Meeting. April 27-May 1, 2023. Abstract PD41-03.doi: 10.1097/JU.0000000000003346.03

4. Kaplan SA, Pichardo M, Rijo E, et al. At 4 years, Optilume BPH has the highest sustained improvement in peak flow (QMAX) of any minimally invasive BPH therapy. 2023 AUA Annual Meeting. April 27-May 1, 2023. Abstract MP76-02. doi: 10.1097/10.1097/JU.0000000000003350.02