ASPIVIX SA today announced that Carevix, its novel Cervical Stabilizer, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). This next generation device for routine procedures in gynecology will allow millions of women across the USA access to significantly less painful treatments and IUD insertions.
Carevix is an atraumatic cervical stabilizer that utilizes a gentle approach to reduce pain and bleeding in multiple transcervical procedures, such as, Intrauterine Device insertions. In our ADVANCE Women, single-blinded, randomized, multicentric, comparative study of 100 women who underwent an IUD insertion with either the Carevix device or a traditional cervical tenaculum, women reported statistically significant results with up to 73% reduction of pain scores and 78% reduction of bleeding occurrences in favor of the Carevix device.
Carevix is the result of our constant commitment to make gynecology, now modern.