Aspivix receives U.S. FDA Clearance for Carevix™, Their Novel Cervical Stabilizer

Carevix™, a novel atraumatic cervical stabilizer created by the Swiss startup ASPIVIX SA, received 510(k) clearance from the U.S. Food and Drug Administration (FDA).

A more gentle and efficient tool for gynecology. 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 favour of the Carevix™ device.

The study, conducted at Geneva University Hospitals (HUG) and Lausanne University Hospital (CHUV), were shared at the 16^th Congress of the European Society of Contraception and Reproductive Health:

• Women in the Carevix study arm reported significantly lower pain scores at all relevant points of the IUD procedure. Pain scores were 52% lower with the Carevix device during cervix grasping, 53% lower during cervix stabilization (traction), 30% lower during IUD insertion, and 33% lower during cervix release, compared to tenaculum use.
• Women who had not given birth (nulliparous), experienced the greatest benefits from Carevix. During IUD insertion, twice as many nulliparous women in the Carevix group were free of pain compared to those in the tenaculum group, and they reported an 88% lower rate of severe pain.
• Bleeding rates were 78% lower with Carevix vs. the tenaculum.

“The IUD is 99% effective in preventing pregnancies and is considered the most cost-effective birth control method available, but many women experience pain and bleeding during IUD placement, leading to the use of less effective methods out of fear of procedural pain,” said Dr. Michal Yaron, ADVANCE Women investigator and Head of Outpatient Gynecology Consultations, Department of Woman, Child & Adolescent, Geneva University Hospitals. “The highly compelling results from the ADVANCE Women study demonstrate that Carevix is a promising and important alternative technology that has the potential to dramatically improve the IUD placement experience for women around the world.”

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

https://www.youtube.com/watch?v=Z1aUVpecRdc

Source: Press Release