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iTind — Temporary Implantable Nitinol Device

iTind temporarily expands within the prostatic urethra and bladder-neck region to remodel the outlet through sustained pressure. It is removed after five to seven days, leaving no permanent implant. This distinguishes it from UroLift, but is not unique among BPH treatments.[1]

For selection, placement and removal, see iTind.

Device and Labeled Use​

The system includes a preformed nitinol implant, insertion/retrieval accessories and a retrieval thread. The June 2021 FDA clearance, which references the earlier De Novo authorization, indicates treatment of symptoms due to urinary outflow obstruction secondary to BPH in men aged 50 years or older. It does not itself state a universal 75 mL maximum. Selection also depends on anatomy, trial eligibility, contraindications and the current local instructions.[1]

The short indwelling interval requires an explicit removal appointment and instructions for dysuria, hematuria, urgency, inability to void and possible infection. “Temporary” does not mean complication-free or that later outlet surgery will never be needed.[2]

Evidence​

The 2021 randomized sham-controlled trial enrolled 175 men, with unblinding at three months. At that comparison, a reduction of at least three IPSS points occurred in 78.6% of the iTind group versus 60% of the sham group. The active group maintained a mean 9.25-point IPSS improvement at 12 months. No new erectile or ejaculatory dysfunction was reported, but this small trial cannot guarantee preservation for every patient.[2]

The older three-year Porpiglia study followed a 32-patient first-generation TIND cohort. It is not a three-year report of the later randomized iTind trial, and its outcomes should not be relabeled as such.[3]

Discuss a removable implant, symptom improvement, the possibility of retreatment and the limits of longer-term comparative evidence together. The published feasibility experience does not establish equivalence to resection or enucleation in large glands, retention or complex prior reconstruction.

References​

1. FDA. iTind System, K210138. June 25, 2021. Clearance, indications and device summary.

2. Chughtai B, Elterman D, Shore N, et al. "The iTind temporarily implanted nitinol device for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia: a multicenter, randomized, controlled trial." Urology. 2021;153:270–6. doi:10.1016/j.urology.2020.12.022

3. Porpiglia F, Fiori C, Amparore D, et al. "Three-year follow-up of temporary implantable nitinol device implantation for the treatment of benign prostatic obstruction." BJU Int. 2018;122(1):106–12. doi:10.1111/bju.14141