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    Tools Test Drive: Sureglide, Überlube, and TruClear

     

    TruClear ULTRA Mini tissue removal device

    Background

    Circa 1998, Dr Mark Hans Emanuel in the Netherlands went into his garage with an orthopedic shaver and came out with the first hysteroscopic mechanical tissue morcellator. Five years later in 2003, Smith & Nephew received 510(k) clearance from the FDA and the Smith & Nephew IUR Morcellation System (now TruClear, owned by Medtronic) was ready for clinical use in the US. Some 14 years and tens of thousands of hysteroscopic morcellation procedures later, hysteroscope mechanical tissue morcellation is a standard for many gynecologists for resecting intracavitary uterine pathology.

    For those physicians who have been practicing in a cave and are unfamiliar with hysteroscopic mechanical morcellation here is a quick primer. Hysteroscopic mechanical morcellators utilize device-specific operating hysteroscopes with integrated optics, inflow and outflow channels and large open central lumens through which proprietary morcellator devices can pass. They function best with high inflow/outflow fluid management systems that can accommodate the large fluid burdens that accompany the procedures due to the need to replace the distention media that is suctioned off removing morcellated tissue. The TruClear system is available in 2 sizes: TruClear 8.0, a 9 mm (27 Fr) hysteroscope for larger pathology and the nimbler TruClear 5C or 5.0, a 5.7 mm (17 Fr) hysteroscope for smaller pathology. The business ends of these systems are single-use tissue removal devices that pass through the central lumens and simultaneously morcellate and aspirate targeted tissues. They come in 2 designs: a rotating serrated blade for softer tissues (i.e. polyps, retained POCs) and a more robust reciprocating, guillotine-style cutting blade for denser tissues (i.e. submucus myomas). Until now, only the larger TruClear 8.0 had a reciprocating cutting bladder but the Ultra Mini changes that.

    Design/Functionality

    TruClear ULTRA Mini tissue removal device is a single-use, stainless steel, 2.9 mm OD instrument designed to function with the TruClear 5C or 5.0 hysteroscope set. Like its 4.0-mm OD cousin, the TruClear ULTRA Plus device has a reciprocating, guillotine-style cutting blade designed to resect denser tissues. But unlike its zaftig relative, the ULTRA Mini fits through a 5.7 mm hysteroscope.

    In use in the OR, the ULTRA Mini was a tissue-chomping beast. The company claims that ULTRA Mini resects tissue at 4.4 grams/minute. While this is Usain Bolt range speed (typical myoma resection rates for morcellators are more in the range of 1.87-3.77 grams/minute1), nothing in my initial OR experience left me doubting it. In this niche, ULTRA Mini is best-in-class. If Medronic can just redesign the TruClear 5C or 5.0 hysteroscopes with glass-rod rather than fiber optic lens, the whole system would be close to perfect.

    Innovation

    While the bulk of users may not appreciate it, ULTRA Mini is an impressive innovative accomplishment. As these devices get smaller and smaller, the engineering challenges get exponentially greater. Reciprocating speeds, blade angles, tissue clearance etc. all have narrow tolerances with each component potentially killing performance. I have no idea exactly how the engineers used this combination of stainless stain tubes and blades with silicone and chromium coatings to make this device work but they did and they did it well.

    Value

    ULTRA Mini is not cheap. If fact, at $1097 it is the Bentley of hysteroscopic instruments. That said, there are two considerations. First, nobody pays list. Second, we are talking value not cost. In that regard the real questions should be, “does this device allow surgeons to accomplish what they set out to accomplish, how efficiently were they able to do it and was it worth it?” In a recent metaanalysis, Shazly et al. demonstrate that as compared with hysteroscopic loop resections, hysteroscopic morcellation procedures were faster and more complete.2 So, depending on your hospital’s OR costs and your surgeons’ skill sets, this device may be a better value than it first appears. While this hardly ends the argument, I do think it is an important consideration when valuing this technology.

    Summary

    In my opinion, hysteroscopic mechanical morcellation is an evolving alternative to traditional loop resectoscopy that just got even more enticing with the introduction of the TruClear™ ULTRA Mini tissue removal device. With the combination of its small size and large tissue resecting potential, I think ULTRA Mini will alter the hysteroscopy landscape as surgeons assimilate this new technology’s potential into their practices.

    REFERENCES

    1. Meulenbroeks D, Hamerlynck TW, Saglam-Kara S, Van Rijssel NK, Van Vliet HA, Schoot BC. Hysteroscopic Tissue Removal Systems: A Randomized In Vitro Comparison. J Minim Invasive Gynecol. 2017 Jan 1;24(1):159-164

    2. Shazly SA, Laughlin-Tommaso SK, Breitkopf DM, Hopkins MR, Burnett TL, Green IC, Farrell AM, Murad MH, Famuyide AO. Hysteroscopic Morcellation Versus Resection for the Treatment of Uterine Cavitary Lesions: A Systematic Review and Meta-analysis. J Minim Invasive Gynecol. 2016 Sep-Oct;23(6):867-77

    James Greenberg, MD
    Dr. Greenberg is Chief, Division of Gynecology, Brigham & Women’s Faulkner Hospital, and Associate Professor, Harvard Medical School, ...

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