iTind BPH device officially launches in Canada

Author(s):

The first patient in a commercial setting in Canada has been treated for benign prostatic hyperplasia (BPH) with iTind, according to Olympus, the developer of the device.¹

The iTind procedure was performed by Dean Elterman, MD, a urologist at University Urology Associates and a faculty member in the University of Toronto's Division of Urology.

"Too often, men will stay silent about the symptoms they are experiencing from an enlarged prostate that hamper their day-to-day lives, such as the urgent need to urinate or sleepless nights because they are frequently waking up to pee," Elterman stated in a news release. "I'm thrilled to offer patients the option of the minimally invasive, relatively low-risk iTind procedure that can be performed in an office setting and provide quick and effective relief from symptoms."

Clinical support for iTind

Long-term data from the MT02 study of iTind were presented during the 2022 AUA Annual Meeting.² The device showed continued efficacy and safety in patients with lower urinary tract symptoms (LUTS) related to benign prostatic obstruction (BPO).

The results, which came at a follow-up time of 50 to 79 months, demonstrated that the temporary implantable nitinol device sustained previously reported MT02 study outcomes, with iTind continuing to show a marked reduction in symptoms and improvement in quality of life and functional parameters.

“Overall IPSS and IPSS-QoL scores improved significantly for all groups vs baseline (P <.0001),” Daniele Amparore, Division of Urology, Department of Oncology, University of Turin School of Medicine, Italy, said when reporting the findings at the AUA meeting.

“Only 4% of treatment failures occurred after 3-years’ follow-up,” added Amparore.

iTind offers patients an alternative to pharmaceutical management and surgery for alleviating LUTS related to BPO. It is an in-office procedure in which urologists place the device in a folded configuration in the prostatic urethra. During the next 5 to 7 days, the device expands before urologists completely remove it.

Overall, the MT02 study enrolled 81 patients with BPO-related LUTS at 9 global locations. At initial study baseline, these patients had IPSS of 10 or higher, Q_max (peak urinary flow) less than 12 ml/sec, and a prostate volume less than 75 ml. To avoid confounders, there was a mandatory wash-out period of 6 months for 5-ARIs and 1 month for alpha-blockers.

Three (Italy, Switzerland, and Belgium) of the 9 original sites agreed to continue the study beyond 36 months. Subsequently, there were 50 patients followed-up at these sites. For their analysis, the investigators divided the patients into 3 groups based on patients’ follow-up time: 50-59 months, 60-71 months, and 72-79 months.

Overall, data were available for 42 patients with 50 to 79 months of follow-up. Of the 42 patients, 24 had a follow-up time of 50 to 59 months, 13 had a follow-up time of 60 to 71 months, and 5 had a follow-up time of 72 to 79 months. There were 4 patients lost to follow-up, 2 patients who died of causes unrelated to iTind, and 2 patients with treatment failures (1 received TURP, and the other ThuLEP). Additional medication was not required for any patients in the study.

The change in average IPSS from baseline to follow-up was -8.88±8.96, -10.31±5.07, and -9.60±6.69, for the 50-59 months, 60-to-71 months, and 72-to-79 months groups, respectively. These numeric changes translated to percent changes of -41.0%, -54.6%, and -50.3%, respectively (P <.0001 for all).

The change in average IPSS-QoL score was -2.04±1.81, -1.85±1.52, and -1.80±0.84, respectively. These numeric changes translated to percent changes of -46.8% (P <.0001), 43.8% (P <.0001), and -51.3% (P = .0015), respectively.

Regarding safety, there were no patients who had late post-operative complications.

Reference

1. First BPH Treatment Procedures Performed in Canada with Minimally Invasive iTind Device. Published online June 23, 2022. Accessed June 28, 2022. https://prn.to/3u7FBhx

2. Amparore D, De Cillis S, Fiori C, et al. Long term follow-up of an international multicenter prospective study in application of temporary implantable nitinol device (iTind) in men with lower urinary tract symptoms for BPH. Presented during 2022 AUA Annual Meeting; New Orleans, LA. Abstract LBA01-06.