Aspivix has published results from a multicenter post-marketing study of its carevix device, a suction-based cervical stabilizer designed to replace the traditional tenaculum during IUD insertion. The study was published in the peer-reviewed International Journal of Gynecology & Obstetrics.
The study analyzed 1,123 IUD procedures using carevix across 19 sites in the United States, Austria, Brazil, France, Germany, Italy, Sweden, Switzerland, and the UK. Nearly half (46%) of participants were nulliparous.
Key findings include 94% overall patient satisfaction, with 73% of participants reporting the procedure was less painful than expected and 81% saying they would tell friends the procedure was easy or pain was manageable. Healthcare professionals reported overall satisfaction in 82% of procedures and stated ease of use, adequate visibility, and perception of low patient discomfort in at least 90% of procedures.
“Our study results in this widely respected and peer-reviewed publication underscore the strong endorsement carevix continues to receive from both clinicians and patients alike,” said Mathieu Horras, CEO of Aspivix. “We are changing gynecological care, and the strong clinical evidence will help support our expanding commercial activities in the US and globally.”
The carevix device uses suction to gently grasp and hold the cervix during IUD insertion and other transcervical procedures, replacing the tenaculum – a sharp-toothed forceps that has been used in gynecology for over a century.
“For far too long, women and people with a uterus have been expected to endure pain and discomfort during routine gynecological procedures,” said Ikram Guerd, General Manager US at Aspivix. “Our most recent study results put a spotlight on the fact that those hardships no longer need to exist and there is a gentler and easier option in gynecological care.”
Aspivix is based in Switzerland. The carevix device has received FDA clearance, CE-Mark, MHRA, and ANVISA approval
