FDA OKs Elekta’s Geneva Brachytherapy Applicator for Cervical Cancer

Elekta announced its Geneva Universal Gynecological Applicator recently received U.S. FDA 510(k) clearance, enabling individuals with cervical cancer in the United States to benefit from the applicator’s ability to precisely target brachytherapy, a radiotherapy method in which a radiation source is introduced directly into the cancer. Designed for cervical cancer up to stage IIB, Geneva would be able to help up to 75 percent of patients with locally advanced cervical cancer.
 
Worldwide, there are 570,000 thousand new cervical cancer cases each year and 310,000 deaths from previously diagnosed cervical cancers, according to GLOBOCAN 2018 statistics. In the United States, the American Cancer Society estimates there will be about 13,800 new cervical cancer diagnoses in the United States in 2020 and approximately 4,300 women will die from the disease.
 
With the availability of Geneva, clinicians can now take advantage of a single gynecological applicator to treat most cervical cancer patients via intracavitary and/or interstitial brachytherapy treatment options. With a comprehensive range of ovoid (13-40 mm) and intrauterine tube (30-80 mm) sizes, in addition to a new interstitial intrauterine tube to expand treatment options after hysterectomy, Geneva can accommodate most female anatomies. In addition, with its “click together,” screwless design, the applicator is simple to assemble.
 
According to internationally accepted guidelines by ASTRO and other clinical societies, brachytherapy is an indispensable addition to external beam radiotherapy. Intracavitary brachytherapy involves the use of an applicator such as Geneva in the vagina and/or cervix. Geneva also enables interstitial brachytherapy, which involves the use of needles through which the radiation source can reach outside of the cervix in advanced cases.
 
“In the United States, Pap and HPV testing have been successful at continuously reducing the incidence of cervical cancer. For the many women who are still confronted with this disease, excellent treatments that include brachytherapy are available to reduce mortality,” says John Lapré, President, Elekta Brachytherapy Solutions. “Elekta is committed to innovation in the field of cervical cancer brachytherapy, which is a proven technique for improved overall survival. Geneva is our latest effort to give clinicians purpose-built solutions to address this health crisis among women.”