UroLift now reimbursed in France for BPH

The UroLift System is now reimbursable under French mandatory health insurance for the treatment of patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH), according to Teleflex Incorporated, the manufacturer of the minimally invasive treatment.

Specifically, a procedural code is now available to hospitals in France enabling use of UroLift to treat men aged ≥50 years with symptoms of an enlarged prostate up to 100 cc.

UroLift is a permanent implant that relieves prostate obstruction. The implant, “holds the enlarged prostate tissue out of the way so it no longer blocks the urethra.” It is inserted transurethrally in an outpatient procedure that usually takes under 1 hour. UroLift does not require either ongoing medication or cutting, heating, or removal of prostate tissue.

“Today’s decision means men in France finally have a safe and effective treatment option which does not compromise on sexual function. As patients can be treated with the UroLift System in an ambulatory setting, rather than a classical operating theatre, and allows patients to be discharged quickly, usually without a catheter, it gives French urologists a new way to relieve some of the pressure on resources caused by the COVID-19 pandemic and pause on elective surgeries,” Matt Wiggins, Interventional Urology General Manager, Teleflex EMEA, stated in a press release.

“The UroLift System has the potential to save hours of theatre time and bed days, while reducing complications and waiting lists, making it a timely alternative for those wishing to ease the strain on current services,” added Wiggins.

In the United States, UroLift was cleared by the FDA in 2013. A key study demonstrating the efficacy of the implant was the LIFT trial, which included 206 patients with BPH-related LUTS. The study randomized 140 patients to UroLift and 66 to sham. Results showed that UroLift reduced the American Urological Association Symptom Index (AUASI) score by 11.1 ± 7.67, compared with a reduction of 5.9 ± 7.66 with sham (P = .003).

The findings from LIFT also showed that at 3 months, peak urinary flow rate with UroLift increased by 4.4 ml per second. At 12 months, this was sustained at 4.0 ml per second. Also of note, no patients experienced de novo ejaculatory or erectile dysfunction with UroLift. Regarding safety, the majority of adverse events observed were mild and did not last long.

According to Teleflex, both the American Urological Association and European Association of Urology clinical guidelines recommend UroLift for the treatment of BPH.

In July 2020, Teleflex announced that 200,000 patients worldwide had been treated with UroLift.