Urotronic’s drug-coated balloon has successfully been used in the first commercial procedure at the University Urology Associates in Toronto, Canada.
Called Optilume BPH, the therapy has been developed for lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH), also known as benign prostate enlargement. It received US Food and Drug Administration (FDA) approval in December 2021.
The minimally invasive therapy involves a double lobe balloon that is mechanically dilated to achieve anterior commissurotomy separating the lateral lobes of the prostate. The simultaneous delivery of paclitaxel, a type of chemotherapy drug, maintains the patency of the lumen during healing.
US-based Urotronic presented results from two clinical trials evaluating the device’s effectiveness and durability at the American Urological Association annual meeting held from 28 April to 1 May 2023.
The company said results at 12 months in the PINNACLE trial (NCT04131907) demonstrated a peak urinary flow rate improvement of 8.9mL/s at baseline to 19mL/s at a follow-up a year after treatment. Urotronic stated that “Optilume BPH has the highest average peak urinary flow rate (Qmax) at 12 months reported in any randomised MIST trials for BPH.”
The company continues to follow up with patients for up to five years after the therapy in its EVEREST trial (NCT03423979).
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By GlobalDataDr Dean Elterman, who completed the procedure, said: “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.
“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.”
A market analysis model by GlobalData estimates the nephrology and urology devices market will be worth $13.2bn by 2030.
