ASPIVIX SA, an innovator and developer of medical technologies to advance gynaecological care, 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 gynaecology will allow millions of women across the USA access to significantly less painful treatments and IUD insertions.

Carevix is an innovative, soft-suction cervical device designed as a modern and gentler alternative to a cervical tenaculum when stabilization of the cervix is needed. By leveraging suction technology to gently stabilize the cervix, Carevix delivers cervical engagement without the need to perforate the tissue. A semi-circular, anatomical pad is applied onto the delicate tissue during gynaecological procedures, reducing significantly trauma associated with pain and bleeding.

In their 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 favour of the Carevix device.

Mathieu Horras, Chief Executive Officer of ASPIVIX said: “With the 510(k) clearance of Carevix, a design-award winning device, we will provide our U.S. customers with an innovative and easy-to-use system that brings a gentler alternative to a century-old gynaecological tool. Extensive research was incorporated into the development of Carevix so we know the unique and differentiating features it demonstrates with significant less pain and bleeding that has the potential to dramatically improve the IUD adoption and placement experience for millions of American women.”

For more information, visit: www.aspivix.com

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