FDA clears Elekta advanced cervical cancer device for sale

Elekta’s Venezia brachytherapy applicator--Courtesy of Elekta

The FDA has cleared Elekta’s Venezia brachytherapy applicator for use in the treatment of cervical cancer. The device is designed to eliminate the need for freehand needle placement when delivering radiation to cervical tumors that extend to the parametrium, vagina and perineum, making it possible for more physicians to perform interstitial brachytherapy.

Research suggests adding brachytherapy, the placement of radioactive seeds in or near a tumor, to external beam radiation therapy increases the overall survival of cervical cancer patients by 12% at four years. However, when tumors extend beyond the cervix to affect adjacent areas such as the perineum, it is challenging for physicians to safely deliver radiation to the extremities of the cancer. Experienced physicians perform the procedure freehand, but not all sites have such staff.

"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 ... is only available in the minority of radiation oncology programs around the world,” Brigham and Women's Hospital's Dr. Phillip Devlin said in a statement.

Elekta is pitching Venezia as a way for all sites to perform brachytherapy in a standardized and reproducible manner. Venezia combines features from ring and ovoid applicators in an attempt to fuse the best characteristics of both types of device. Specifically, Elekta wanted Venezia to be as easy to apply as an ovoid device and have the dose distribution that characterizes ring applicators.

Venezia provides physicians with a grid of holes through which to insert needles. In recognition of research showing best results are achieved in some patients when needles are inserted straight and on an angle—obliquely—Elekta has designed its grid to support both approaches. By looking at scans of the tumor, physicians can determine the mix and placement of straight and oblique needles that will target the cancer most effectively prior to starting the procedure.

Elekta picked up a CE mark for Venezia in November, and has now followed up by gaining 510(k) clearance from FDA. The product is part of a suite of applicators and related brachytherapy technologies sold by Elekta.