New treatment solution for U.S. cervical cancer patients now available for clinical use
Elekta has received U.S. FDA 510(k) clearance for its Geneva Universal Gynecological Applicator, enabling enhanced brachytherapy treatment for cervical cancer patients in the U.S. This device is designed for cervical cancer up to stage IIB and can assist 75% of patients with locally advanced cases. Each year, there are 570,000 new cervical cancer diagnoses globally. Elekta's Geneva aims to support these patients by providing a versatile, easy-to-use applicator with multiple size options. The innovation aligns with established guidelines, enhancing treatment efficacy.
- FDA clearance for Geneva Applicator marks significant step in cervical cancer treatment.
- Applicator designed to assist up to 75% of patients with locally advanced cervical cancer.
- Single applicator allows for both intracavitary and interstitial brachytherapy options.
- None.
STOCKHOLM, Aug. 19, 2020 /PRNewswire/ -- Elekta (EKTA-B.ST) announced today that 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."
To learn more, visit elekta.com/Geneva.
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For further information, please contact:
Mattias Thorsson, Vice President, Corporate Communications
Tel: +46 70 865 8012, e-mail: Mattias.Thorsson@elekta.com
Time zone: CET: Central European Time
Raven Canzeri, Global Public Relations Manager
Tel: +1 770 670 2524, e-mail: Raven.Canzeri@elekta.com
Time zone: ET: Eastern Time
About Elekta
For almost five decades, Elekta has been a leader in precision radiation medicine. Our more than 4,000 employees worldwide are committed to ensuring everyone in the world with cancer has access to - and benefits from - more precise, personalized radiotherapy treatments. Headquartered in Stockholm, Sweden, Elekta is listed on NASDAQ Stockholm Exchange. Visit elekta.com or follow @Elekta on Twitter.
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SOURCE Elekta
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