Research Project
8900205
DESCRIPTION (provided by applicant): Benign uterine tumors (fibroids) are clinically apparent in up to 50% of women and typically require surgical removal of symptomatic fibroids or hysterectomy. Treatment options for women considering bearing children are limited to the invasive surgical open myomectomy to best maintain structural integrity of the uterine wall; the less invasive laparoscopic removal is contraindicated. There remains a substantial clinical need for a minimally-invasive alternative to traditional surgical approaches with the promise of less morbidity and recovery time, faster procedure time, and lower cost. Recent clinical investigations using minimally-invasive thermal ablation (e.g., RF, laser, cryotherapy, HIFU) have demonstrated significant potential in reducing fibroid volume and providing symptomatic relief. Limitations of these techniques include an inability to spatially control the distribution f energy to conform to the fibroid volume, inadequate single treatment volumes requiring multiple device insertions, long procedural times, or use may be limited by the proximity of a fibroid to critical tissue structures (e.g., bladder, bowel). High-intensity interstitial ultrasound devices fr volumetric fibroid ablation have been developed in a Phase I project, with demonstrated capabilities to provide dynamic spatial control of selective heating patterns, enhanced radial thermal penetration, and fast heating times. This ultrasound technology can provide a superior minimally-invasive technique for volumetric ablation treatment of uterine fibroids with the promise of more accurate and thorough targeting, protection of critical non-targeted tissue (e.g., bladder, bowel), accessibility to a larger number of fibroids, and faster procedure times. The objective of this Phase II research & commercialization plan is to finalize development of laparoscopic and transcervical conformal high-intensity interstitial ultrasound devices and spatial control capabilities specific for conformal thermal ablation of large volumes required for successful treatment, with complete delivery system and treatment strategies, specific to precision image-guided volumetric fibroid ablation and approved for clinical study.
