Nucletron, an Elekta Company, Receives US FDA 510(k) Clearance for Esteya Electronic Brachytherapy System for Treating Skin Cancer
Stockholm, October 2 – Esteya®, an electronic brachytherapy system, has received 510(k) clearance from the US Food and Drug Administration (FDA), enabling medical centers in the United States to offer their patients with skin cancer a new treatment option.
Esteya is a new approach for high precision skin cancer treatment. The system relies on a small high dose rate (HDR) x-ray source to apply radiation directly to the cancerous site. This direct delivery enables Esteya to focus more therapeutic radiation on the disease target and to minimize radiation to surrounding tissues and organs. Electronic brachytherapy is well-suited for treating skin lesions, such as basal cell or squamous cell carcinoma, achieving a greater than 95 percent cure rate for this technique1.
“The interest in Esteya among radiation oncologists during the American Society for Radiation Oncology annual meeting last week in Atlanta was encouraging,” says John Lapré, Executive Vice President, Brachytherapy at Elekta. “They appreciated the efficient workflow, easy patient set-up, and the short treatment delivery time. They also cited the accessibility of Esteya – due to its compact design and reduced shielding requirements – allowing treatment to occur virtually anywhere patients are seen within the clinic.”
The first installations of Esteya in the United States are scheduled to occur in the next few months.
To learn more about Esteya, visit Esteya.com.
Availability of Esteya in target markets is dependent on regulatory admissions and approvals.
# # #
For further information, please contact:
Johan Andersson, Director, Investor Relations, Elekta AB
Tel: +46 702 100 451, email: johan.andersson@elekta.com
Time zone: CET: Central European Time
Michelle Joiner, Director, Global Public Relations and Brand Management, Elekta
Tel: +1 770-670-2447, email: michelle.joiner@elekta.com
Time zone: ET: Eastern Time
About Elekta
Elekta is a human care company pioneering significant innovations and clinical solutions for treating cancer and brain disorders. The company develops sophisticated, state-of-the-art tools and treatment planning systems for radiation therapy, radiosurgery and brachytherapy, as well as workflow enhancing software systems across the spectrum of cancer care. Stretching the boundaries of science and technology, providing intelligent and resource-efficient solutions that offer confidence to both healthcare providers and patients, Elekta aims to improve, prolong and even save patient lives.
Today, Elekta solutions in oncology and neurosurgery are used in over 6,000 hospitals worldwide. Elekta employs around 3,500 employees globally. The corporate headquarters is located in Stockholm, Sweden, and the company is listed on the Nordic Exchange under the ticker EKTAb. Website: www.elekta.com.
_____________________________________
1 Bhatnagar A. Nonmelanoma skin cancer treated with electronic brachytherapy: results at 1 year. Brachytherapy. 2013 Mar-Apr;12(2):134-40.