Elekta wins FDA 510(k) clearance for Venezia gynecological brachytherapy applicator

Elekta (STO:EKTA B) said today it won FDA 510(k) clearance for its Venezia applicator for gynecological brachytherapy, now cleared for the treatment of advanced-stage cervical cancer.

The company’s Venezia device is designed to facilitate pre-defined, consistent needle placement for interstitial brachytherapy and to allow operating clinicians the ability to access 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. 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,” Dr. Phillip Devlin of Boston’s Brigham and Women’s Hospital said in a prepared statement.

The Swedish company said it won CE Mark approval in the European Union for the Venezia last November.

“To develop Venezia, we collaborated with physicians and physicists at the cutting edge of 3D image-guided adaptive brachytherapy. 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,” Elekta brachytherapy portfolio VP Maarten ter Mors said in a press release.

Last September, Elekta said it and its MRI tech partner Royal Philips (NYSE:PHG) began installation of an investigational high-field MR-adaptive linear accelerator system at Wisconsin’s Froedtert & MCW Clinical Cancer Center at the Froedtert Hospital.

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