All the procedures were performed by residents in training under the direct guidance of an attending physician. The morcellation group demonstrated selleck catalog a 38% reduction in operating room (OR) time (17 min vs 10.6 min; P = .008) as well as a 32% reduction in distention media used (5050 mL vs 3413 mL; P = .041). Not surprisingly, the trial also demonstrated a marked reduction in the number of insertions and reinsertions of the hysteroscope to remove chips when the morcellator was used (number of insertions = 1 [range, 1�C2]) compared with the resectoscope (number of insertions = 7 [range, 3�C50]).20 Looking again at polyps and Type I and Type II submucous myomas but using the newer MyoSure device, Miller and coworkers reported average polyp morcellation times of 37 seconds and average myoma morcellation times of 6.

4 minutes for Type 0, I, and II myomas with a mean diameter of 31.7 mm.21 These data were further validated in a recent abstract by Lukes, who reported using the MyoSure device to remove 6 myomas (�� 3 cm) and 20 polyps in 13 women with a mean resection time of 84 seconds. All 13 procedures were performed in an office setting using local anesthesia with average pain scores < 1 using the Wong-Baker Faces Rating Scale (no pain = 0; worst pain = 10).22 MyoSure Device Versus TRUCLEAR System Although in vivo accurate measurements of tissue resection speed are challenging to conclusively determine due to surgeon and pathology variations, in vitro measurements have been performed to assess the tissue resection characteristics of the different devices.

As part of an IRB-approved FDA submission study in 2008, the author (JAG) compared a working MyoSure device prototype with a TRUCLEAR device to assess tissue resection speed. Fresh, discarded uterine leiomyoma tissue was placed in a saline-filled container and each device was placed directly on the tissue in alternating 5-minute intervals for 30 minutes. The trial was repeated on three different myoma specimens. The study was designed to compare tissue cutting on identical tissue and to assess decline of cutting speed over time as a result of blade dulling. The results are presented in Table 2 and demonstrated graphically in Figure 6.23 As these data demonstrate, both devices are capable of resecting submucous myomas 3 cm in diameter (~15 cc3) in 15 minutes or less, although the MyoSure device was consistently faster at tissue removal at every time interval despite its smaller diameter.

Figure 6 MyoSure? Tissue Removal System (Hologic, Bedford, MA) versus TRUCLEAR? hysteroscopic morcellator (Smith & Nephew, Andover, MA) tissue cutting performance in average grams per minute over 30 minutes. IM, Interlace Medical; SN, predicate … Table 2 Carfilzomib MyoSure? Tissue Removal System Versus TRUCLEAR? Hysteroscopic Morcellator Tissue Cutting Performance In addition, the smaller diameter of the MyoSure hysteroscope (6.25 mm) compared with the TRUCLEAR hysteroscope (9.