FDA OKs Elekta’s Venezia Brachytherapy Applicator for Cervical Cancer Treatment

FDA OKs Elekta’s Venezia Brachytherapy Applicator for Cervical Cancer Treatment

U.S. regulators have approved the Venezia applicator for treating advanced-stage cervical cancer, according to the device’s maker, Elekta.

The Food and Drug Administration‘s (FDA’s) 510(k) clearance  means the applicator can be marketed in the United States. The European Union granted Venezia CE Mark approval in November 2016.

Patients with locally advanced cervical cancer are usually treated with a combination of chemotherapy and radiation.

The radiation component combines external-beam radiation therapy (EBRT) with a brachytherapy boost, which involves placing radioactive seeds inside the tumor. This approach delivers radiation to the cervix in a safe, efficient manner.

A study published in the International Journal of Radiation Oncology looked at whether brachytherapy was effective in treating cervical cancer in the United States. It showed that women with advanced cervical cancer who received a brachytherapy boost after EBRT had a four-year overall survival rate 12 percent higher than women treated with EBRT alone.

The use of 3D-image-guided brachytherapy and interstitial needles to expand the treatment area and conform to the shape of the tumor also generated better outcomes, according to earlier studies. The needles are also radioactive.

The good results from brachytherapy and the needles were especially true for women with larger tumors.

Interstitial brachytherapy may not be as effective in women whose tumors extend outside the cervix, however. That’s because it’s difficult to target tumor tissue precisely, and current applicators fail to reach many tumor areas.

Venezia is a new applicator system that makes it easier for doctors to reach the cervix, connective tissue, and vaginal extensions in advanced cervical cancer. A one-click system lets doctors insert and assemble Venezia with ease, eliminating the need for screws or tools.

Venezia lets doctors treat advanced cervical cancer with interstitial brachytherapy in a pre-defined and reproducible way, ensuring optimal dose distribution for the majority of patients.

“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,” Phillip M. Devlin, MD, chief of the brachytherapy division at Brigham and Women’s Hospital, said in a press release.

“The surgical brachytherapy skill set to do this, however, is only available in the minority of radiation oncology programs around the world. 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,” Devlin said.

“To develop Venezia, we collaborated with physicians and physicists at the cutting edge of 3D image-guided adaptive brachytherapy,” said Maarten ter Mors, vice president of Elekta’s brachytherapy unit. “Our mutual goal was to make this potentially lifesaving treatment available to more patients. 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.”


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