Hologic (Nasdaq:HOLX) announced today that Canadian and European officials approved its NovaSure V5 global endometrial ablation (GEA) device.
Marlborough, Massachusetts-based Hologic designed the device to treat a wide range of cervical and uterine anatomies. It offers treatment for abnormal uterine bleeding.
In a news release, Hologic cites 97% patient satisfaction with NovaSure. The device also demonstrated 87% avoidance of a hysterectomy at 10 years.
“Since its launch over 20 years ago, we have constantly listened to our customers’ feedback, which has driven continuous design improvements for NovaSure,” said Jan Verstreken, Hologic group president, international. “This has enabled us to develop our technology to further meet their needs and those of the women they treat, ultimately delivering better outcomes for these women.”
NovaSure V5 features an updated cervical seal with EndoForm technology. Hologic designed EndoFrom to increase the sealing surface, accommodating a range of cervical canals and anatomical variability.
The device includes AccuSheath markings for improving the accuracy and confidence of seating and fundal placement. Hologic said NovaSure V5 also includes its SureClear fluid removal technology. SureClear provides integrated suction through the array by constant tissue contact. Simultaneously, it removes ablation byproducts including vapor and fluid.
“I welcome the new features on the NovaSure V5. These will support both inexperienced and more established users in performing effective, more efficient and accurate procedures,” said Dr. Philippe Y. Laberge of the CHU de Québec-Université Laval in Québec, Canada. “The addition of markings to the shaft will enable users to correctly place the device before initiating a procedure. The cervical seal is a significant improvement as there is less chance of leaks, allowing the completion of pre-procedure checks and the procedure itself.”