Pelvalon Blessed by FDA, Gains Clearance for Next-Gen Eclipse System
Sunnyvale, Calif.-based Pelvalon has scored 510(k) clearance for its second-generation nonsurgical Eclipse therapy for women suffering from a loss of bowel control.
The Eclipse system is a vaginal insert designed to give immediate bowel control. It contains no hormones or drugs and can be removed at any time desired.
Holly Richter, director of the Division of Urogynecology and Pelvic Reconstructive Surgery at the University of Alabama at Birmingham and past president of the Society for Gynecological Surgeons, says the next-generation device can help women who already are adopting lifestyle changes — such as diet and exercise — and offers potential relief before more invasive treatment is required. — Elizabeth Hollis