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Esteya System for Skin Cancer Treatment Gets FDA 510(k) Clearance (VIDEO)

October 4th, 2013 Gaurav Dermatology, Oncology, Plastic Surgery, Surgery

jd83jNucletron, an Elekta company based in Atlanta, GA, has received FDA clearance for the Esteya electronic brachytherapy system for treating patients with skin cancer. According to the CDC, skin cancer is the most common form of cancer in the United States, and each year there are more new cases of skin cancer than the combined incidence of cancers of the breast, prostate, lung and colon. Though surgery is the main treatment strategy for skin cancer, High Dose Rate (HDR) brachytherapy for nonmelanomatous skin cancer, such as basal cell carcinoma and squamous cell carcinoma, provides an alternative treatment option. Electronic brachytherapy offers a refined treatment modality with a cure rate greater than 95%. The Esteya electronic brachytherapy system mimics HDR brachytherapy by bringing a small X-ray source very close to the lesion, enabling the local application of radiation for optimal treatment.

esteya

The Esteya system uses click-on applicators that offer easy maneuverability and are guided by a  high-brightness LED array. The system promises very short treatment time (less than 3 minutes) due to a high dose rate of of 2.6 Gy/m at 3mm and multiple lesions can be treated in a single session. Esteya requires only minimal room shielding and is highly portable, allowing the treatment to occur virtually anywhere patients are seen. A tungsten applicator shield protects healthy tissue from excessive radiation exposure. The automated applicator detection minimizes human errors and eliminates time-consuming manual steps by automatically noting whether the applicator attached to the system is aligned with the applicator that was selected in the treatment plan.  The Esteya system also has an optimized workflow, featuring data management and patient setup, reducing the time lag between patient entry into the treatment room to the start of actual treatment.

The Esteya system is especially relevant for cancers of the nose, ears, eyelids or lips, where surgery may cause disfigurement or require extensive reconstruction. The Esteya therapy is also a viable option for patients with high risks of post operative complications from surgery.


Product page: Esteya…

Press release: Nucletron, an Elekta Company, Receives U.S. FDA 510(k) Clearance for Esteya Electronic Brachytherapy System for Treating Skin Cancer

Gaurav

Gaurav Krishnamurthy, PhD is a Senior R&D engineer at a Bay Area based medical device start-up. Gaurav has a strong passion for medical device innovation and is interested in disruptive medical technologies that not only solve an unmet clinical need, but also bring down the cost of healthcare. Gaurav closely follows medical device trends in emerging markets and is fascinated by simple and inexpensive solutions to major healthcare problems. Gaurav earned his PhD and Master's in Mechanical Engineering from Stanford University where he developed state of the art computational models of beating heart valves that can be used to design and test heart valve prosthetics. Gaurav was a Medtronic BioX Fellow at Stanford University. Gaurav also serves as a Senior Advisor to a Bay Area angel investment group focusing on mobile health and healthcare innovation.

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