The U.S. FDA has granted Elekta 510(k) clearance for its Venezia applicator for gynecological brachytherapy, a device that will be used to treat advanced-stage cervical cancer. Venezia, which utilizes 3D image-guided brachytherapy, received the European CE Mark in November.

Studies have shown that the use of 3D image-guided brachytherapy using interstitial needles that expand the treatment area and conform to the shape of the tumor is associated with improved clinical outcomes, especially for patients with larger tumors. Despite these findings, the use of interstitial brachytherapy in patients with tumors that extend outside of the cervix may be underutilized due to the limited reach of existing applicators and the complexity of precisely targeting tumor tissue.

Venezia, however, facilitates pre-defined and consistent needle placement for every procedure, and allows clinicians to access difficult-to-reach tumors that extend outside of the cervix.

“There is overwhelming clinical evidence that modern image-guided brachytherapy is an effective treatment modality for cervical cancer. Advanced stage disease, however, often requires an interstitial technique due to a less-than-complete response to chemoradiation therapy,” says Phillip M. Devlin, MD, FACR, FASTRO, FFRRCSI (Hon), chief of the division of brachytherapy, Brigham and Women’s Hospital. “Modified intracavitary applicators that allow better interstitial coverage and require less technical skill and training have the potential to increase access of this needed therapy to more women.”

Maarten ter Mors, vice president of Elekta’s brachytherapy portfolio, also spoke out about Venezia, commenting: “Although we initially focused on advanced-stage disease, Venezia has evolved into an intuitive tool suitable for treating a wide range of gynecological malignancies. We believe it has the potential to positively impact the way gynecological cancers are treated.”

For more information about this device, visit Elekta.