Aspivix, a company specializing in women’s health technology, has recently received CE Mark approval for its Carevix device, indicating its compliance with European health, safety, and environmental protection standards. This approval allows for the commercial use of Carevix in European countries.
Carevix is designed to reduce pain during transcervical procedures, such as the placement of Intrauterine Devices (IUDs). It operates using a soft-suction technique to stabilize the cervix, which aims to be less painful compared to the traditional cervical tenaculum.
The effectiveness of Carevix in reducing trauma and pain during these procedures has been demonstrated in the “ADVANCE Women” study. The results, published in the “Contraception” journal, indicated that CarevixTM was more atraumatic than traditional methods.
With the CE Mark approval, Carevix is now eligible for distribution and use in European healthcare settings. This regulatory milestone confirms the device’s adherence to the essential requirements of relevant European health and safety legislation. Aspvix’s introduction of Carevix to the European market follows its previous FDA clearance, allowing its use in the United States.
Aspivix CEO Mathieu Horras said: “The Carevix device, which had also received 510(k) clearance and won a design award, earlier this year, provides an innovative, clinically proven and user-friendly alternative to a century-old gynecological tool. The extensive research that went into the development of Carevix ensures significant reduction pain and bleeding, improving the IUD adoption and placement experience as well as many other gynecological and fertility procedures for millions of American and European women.”
