ASPIVIX Announces That Contraception, an International Reproductive Health Journal, Has Published First-In-Women Results Using Novel Cervical Stabilizer In IUD Procedures
Renens, Switzerland – 13 March 2023 – ASPIVIX SA, an innovator and developer of medical technologies to advance gynecological and fertility care, today announced the publication of the results in Contraception, an international reproductive health journal, from the ADVANCE Women (Atraumatic Device using VAcuum Technology for CErvical Procedures in WOMEN), a randomized controlled trial of Carevix™, a novel non-traumatic cervical stabilizer.
ADVANCE Women is a single-blinded, randomized, comparative study of 100 women who underwent Intrauterine Device (IUD) insertion with either the Carevix device or a tenaculum, the forceps-like, standard-of-care surgical instrument. Results from the study, conducted at Geneva University Hospitals (HUG) and Lausanne University Hospital (CHUV), show that:
- Women in the Carevix study arm reported statistically and clinically significant lower pain scores at all relevant timepoints of the IUD procedure. Pain scores were 52% lower with the Carevix device during cervix grasping, 53% lower during cervix stabilization (traction), and 30% lower during IUD insertion, compared to tenaculum use.1
- Women who had not given birth (nulliparous), experienced the greatest benefits from Carevix. During IUD insertion, in the Carevix group 88% less nulliparous women reported severe pain than in the tenaculum group.1
- Cervix bleeding occurrence rates were 78% lower with Carevix vs. the tenaculum.
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.1
“The IUD is more than 99% effective in preventing pregnancies and is considered the most cost-effective birth control method available, but because many women experience pain and bleeding during IUD placement, less-effective methods are chosen 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.”
“The publication of the ADVANCE study in Contraception further validates our commitment to providing women with clinically proven gentle solutions for gynecological and fertility needs. With the recent FDA clearance of Carevix™ and with this publication, we are one step closer to re-inventing century-old gynecological tools and procedures.” said Mathieu Horras, Chief Executive Officer of ASPIVIX. “Our mission remains steadfast: to bring innovative technologies to market, designed with women in mind.”
Carevix is an innovative, suction cervical stabilizer designed as a modern and gentler alternative to a cervical tenaculum. 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 gynecological procedures, reducing significantly trauma associated with pain and bleeding.
ASPIVIX SA is a privately held medical device company based in Switzerland, dedicated to developing modern and gentle gynecological solutions that advance women’s healthcare.
Visit www.aspivix.com or stay informed www.aspivix.com/stay-informed/
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1. Michal Yaron, Hélène Legardeur, Bastien Barcellini, Farida Akhoundova, Patrice Mathevet, Safety and efficacy of a suction cervical stabilizer for IUD insertion: results from a randomized, controlled study, Contraception, 2023, 110004, ISSN 0010-7824, https://doi.org/10.1016/j.contraception.2023.110004.
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