First UK hospital adopts pain-reducing cervical device 'Carevix' - as makers Aspivix announce MHRA approval
First UK hospital adopts pain-reducing cervical device 'Carevix' - as makers Aspivix announce MHRA approval
The soft-suction cervical device is a modern, gentler alternative to the tenaculum
Gynaecological solutions company Aspivix has announced that its pioneering cervical device ‘Carevix’ is now in use at its first UK hospital.
The soft-suction cervical device - which is a modern and gentler alternative to the tenaculum - has also secured a milestone approval from the Medicines & Healthcare products Regulatory Agency (MHRA) which allows for its use in the UK.
"Receiving MHRA approval is not just an achievement for Aspivix but a victory for women's healthcare globally," said Mathieu Horras, CEO & Co-Founder of Aspivix.
"This endorsement allows us to bring Carevix to the UK market, further expanding our reach and impact on women's health. With existing FDA approval for the US and CE Mark for Europe, we are poised to make significant advancements in gynaecological care."
Carevix is designed as a more comfortable experience for patients and for healthcare providers. By stabilising the cervix using a soft-suction method, it is used as a less painful alternative to the tenaculum in transcervical procedures in gynaecology, oncology and fertility, including IUD/ coil insertions.
By focusing on minimally-invasive, patient-centric solutions, Aspivix aims to ensure a positive experience for all women - alleviating the pain and bleeding associated with gynaecological transcervical procedures such as coil fitting, hysteroscopies, endometrial biopsies.
Peterborough City Hospital becomes first in the UK to adopt Carevix
Having secured MHRA approval, Peterborough City Hospital - part of the North West Anglia NHS Foundation Trust - has become the first hospital in the UK to use Carevix.
The hospital is now one of 17 worldwide part of the Carevix ‘Ambassador Program’ which allows OB-GYNs, midwives and nurses worldwide (US, Brazil, France, Sweden, Switzerland, Germany, Italy) to use Carevix in routine gynaecological procedures to provide a better experience for women.
“Carevix looks like an excellent product and our team at Peterborough City Hospital is very happy to join the program. I’m sure the patients would love it.” shares Dr. Lukasz Polanski, a member of the Royal College of Obstetricians and Gynaecologists.
Over 600 patients worldwide have now benefited from the Carevix Ambassador Program, with the first US patient announced by Aspivix in May 2024.
Towards commercialisation
Carevix has already received FDA-clearance and CE-Mark approval in 2023 and is available for commercialisation in Switzerland, with other countries available soon.
Earlier this year, Aspivix teamed up with Bayer Switzerland to support its commercialisation.
The device has also been clinically proven to be atraumatic during transcervical procedures with results from the ADVANCE Women (Atraumatic Device using Vacuum Technology for Cervical Procedures in WOMEN), a multisite randomised controlled trial of Carevix, used In IUD Procedures against the cervical tenaculum published in “Contraception”, the International Reproductive Health Journal in 2023.