iTind — Temporary Implantable Nitinol Device
iTind (Medi-Tate; the AUA guideline calls the class a temporary implantable prostate device, TIPD) is a nitinol implant that expands within the prostatic urethra and bladder neck. Its struts push obstructive tissue away from the urinary path through sustained radial force. It is removed after five to seven days and leaves 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 consists of a nitinol implant pre-mounted on a guide wire, a delivery system and a retrieval kit. The folded implant is passed through a sheath into the bladder neck and prostatic urethra. In its expanded configuration it measures at most 33 mm in diameter and 50 mm in length and spans the prostatic urethra from the bladder neck to a point proximal to the external sphincter. It is compatible with cystoscopes of at least 19 Fr. Removal is through a sheath.[1]
The June 2021 FDA clearance (K210138), which references the earlier De Novo authorization (DEN190020), 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 prostate volume limit. The 2021 randomized trial enrolled men with prostate volumes of 25 to 75 mL and excluded an obstructive median lobe. The 2026 AUA guideline states that clinicians may offer TIPD to patients with prostates of 25 to 75 mL without an obstructing median lobe (Expert Opinion). Selection also depends on anatomy, contraindications and the current manufacturer instructions.[1][2][4]
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 (118 iTind, 57 sham) aged 50 years or older, with unblinding at three months. The primary endpoint was a reduction of at least three IPSS points at three months, which occurred in 78.6% of the iTind group versus 60% of the sham group. The AUA guideline reports that the mean IPSS change at three months (9.0 vs 6.6 points) did not differ significantly between groups (p = 0.06). At 12 months, after unblinding, the iTind group reported a 9.25-point IPSS decrease and a 3.52 mL/s rise in peak flow. Adverse events, mostly Clavien-Dindo grade I or II, occurred in 38.1% of the iTind group and 17.5% of the sham group. No de novo erectile or ejaculatory dysfunction was reported, but this small trial cannot guarantee preservation for every patient.[2][4]
The older three-year Porpiglia study followed a 32-patient first-generation TIND cohort with prostate volume below 60 mL. Qmax was 41% above baseline at 36 months, and four early complications (12.5%) were recorded. It is not a three-year report of the later randomized iTind trial, and its outcomes should not be relabeled as such.[3]
A single-arm multicenter study of the second-generation device reported results at 50 to 79 months in 41 of 81 enrolled men. IPSS was 45% below baseline, and surgical retreatment was 4% beyond 36 months. Loss to follow-up limits this report.[5]
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
4. Goueli R, Badlani GH, Welliver C, et al. Management of lower urinary tract symptoms attributed to benign prostatic hyperplasia (BPH): AUA guideline (2026). Part III: Procedural and surgical management. J Urol. 2026;216(2):161-170. doi:10.1097/JU.0000000000005099. Statement 49 and supporting text.
5. Amparore D, De Cillis S, Schulman C, et al. Temporary implantable nitinol device for benign prostatic hyperplasia-related lower urinary tract symptoms: over 48-month results. Minerva Urol Nephrol. 2023;75(6):743-751. doi:10.23736/S2724-6051.23.05322-3