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Elekta receives FDA clearance


Elekta announces that its Venezia applicator for gynecological brachytherapy has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the treatment of advanced-stage cervical cancer.

Venezia received CE Mark approval in November 2016.

“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 Division of Brachytherapy, Brigham and Women’s Hospital. “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.”

“To develop Venezia, we collaborated with physicians and physicists at the cutting edge of 3D image-guided adaptive brachytherapy,” says Maarten ter Mors, Vice President Brachytherapy Portfolio at Elekta. “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.”