Pelvalon Receives FDA Clearance of Second-Generation Non-Surgical Therapy for Women Suffering from Incontinece

Pelvalon announced limited U.S. commercial availability of its Eclipse™ System, following U.S. Food and Drug Administration (FDA) 510(k) clearance for the company’s next-generation device.
According to the company CEO, Miles Rosen:

With this FDA clearance for our next-generation Eclipse, we are excited to initiate the first phase of our commercial launch in select centers of excellence. We believe that this early phase of partnership with thought and practice leaders in the field of pelvic floor disorders will ensure a smooth expansion down the road.

Holly E. Richter, Ph.D., M.D., director of the Division of Urogynecology and Pelvic Reconstructive Surgery at the University of Alabama at Birmingham commented:

Eclipse is a non-surgical therapy offering immediate bowel control that can be used early in the treatment pathway. Like the first-generation device, the next-generation Eclipse is an easily tried approach that fills a gap between lifestyle changes in diet and exercise and more invasive treatments. I’m excited that this new option will soon be available to my patients.

Click here to view the full press release.