In Brief: Gynecare
This article was originally published in The Gray Sheet
Executive Summary
Gynecare: Files 510(k) with FDA for its bipolar vaporization system for uterine fibroid removal. The minimally invasive system incorporates a "novel, electro-vaporization technology" that utilizes saline as an irrigation fluid, Gynecare says. Saline "is considered to be the optimal medium for hysteroscopic procedures because it does not affect normal blood chemistry" like sorbitol or glycine, used in traditional monopolar myomectomy procedures, the company adds. Gynecare estimates that fibroids account for approximately 180,000 (roughly 30%) of hysterectomy procedures annually in the U.S...