In-office rapid volumetric ablation of uterine fibroids under ultrasound imaging guidance: Preclinical and early clinical experience with the Mirabilis transabdominal HIFU treatment system

Mirabilis Medica, Inc. (Bothell, WA, USA) has developed a high-intensity focused ultrasound (HIFU) system for producing rapid transabdominal volumetric ablation of uterine fibroids in an office-based setting. The Mirabilis HIFU Treatment System utilizes integrated ultrasound imaging guidance and short treatment times under 15 minutes. Treatment with the Mirabilis system is generally well tolerated using only oral analgesia without anesthesia or sedation. This paper summarizes certain technical aspects of the Mirabilis HIFU technology, the preclinical development process, and the results of the first in-human clinical study using the Mirabilis system. During preclinical studies, an in vivo transcutaneous porcine lower extremity model was used in a total of 180 adult swine to develop the HIFU treatment regimen parameters. Additionally, 108 excised human uteri with fibroids obtained from scheduled hysterectomies were treated in an ex vivo experimental setup and evaluated. These preclinical activities resulte...