In Brief: Endocare
This article was originally published in The Gray Sheet
Executive Summary
Endocare: Receives investigational device exemption to begin human clinical trials of its CRYOcare 1-Probe cryosurgical system for arresting abnormal uterine bleeding. To effect the treatment, the system's probe is used in conjunction with gel placed in the uterine cavity to freeze endometrial tissue. Endocare claims CRYOcare is more effective than other minimally invasive procedures because the treatment conforms to the shape of the uterus. The firm received 510(k) clearance to market the system for general gynecological use in 1996 and hopes to market the device as an alternative to hysterectomy in some patients...