Esteya receives FDA 510(k) clearance for treating skin cancer

The FDA has granted 510(k) clearance for an electronic brachytherapy system to treat patients with skin cancer, according to manufacturer Nucletron.

Esteya uses a small, high-dose-rate X-ray to apply radiation directly to the cancerous site, according to a press release. The process allows more therapeutic radiation on the disease target and minimizes radiation to surrounding tissues and organs. Cure rates exceed 95% with electronic brachytherapy when treating skin lesions such as basal cell or squamous cell carcinomas, according to Nucletron, an Elekta company.

“The interest in Esteya among radiation oncologists during the American Society for Radiation Oncology annual meeting [recently] in Atlanta was encouraging,” John Lapré, executive vice president, Elekta Brachytherapy, said in the release. “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.”

Pending regulatory admissions and approval, scheduled installations of Esteya in the United States should occur in the next few months, the release said.