The structure of “Rosatom” has registered the domestic linear accelerator “Ellus-6M”
NIIEFA D.V. Efremova (part of the Rosatom state corporation) received approval from Roszdravnadzor for the domestic linear accelerator Ellus-6M with an energy of 6 MeV. The institute developed a prototype accelerator in 2008; clinical trials took place in 2013 and 2021.
NIIEFA received a registration certificate for a medical device on November 11, 2021. As follows from the manufacturer’s data, the accelerator is intended for 3D conformal radiation therapy in multistatic and rotational modes.
The maximum absorbed dose rate of bremsstrahlung is from 3.5 to 5 Gy / min, the field size at a distance of 1 m from the target is from 2 by 2 to 40 by 40 cm, the emitter rotation angle varies up to 185 ° in both directions, and the rotation speed – from 36 ° to 360 ° per minute.
The accelerator is equipped with a multi-leaf collimator and is supplied with an irradiation verification system based on a portal imaging device and an X-ray system for anatomical and topometric preparation.
In 1996, NIIEFA them. D.V. Efremov, using Philips technology, localized the serial production of linear accelerators with a beam energy of up to 6 MeV at the facilities of the Svetlana military-industrial enterprise under the SL-75 brand; as of 2002, 58 pieces of equipment were manufactured and delivered. A new type of accelerators – “Ellus-6M” – was developed by NIIEFA in 2008. Technical tests took place at the N.N. N.N. Petrov. In 2013, the institute received the first approval for clinical trials, the results were not reported.
In June 2019, NIIEFA announced a tender for the registration of Ellus-6M as a medical device, which was won by Certification Body CE-cert for 2.34 million rubles. In January 2021, the manufacturer received a second approval for clinical trials that took place until September 2021 at the Russian Scientific Center for Radiology and Surgical Technologies named after V.I. A.M. Granov of the Ministry of Health of the Russian Federation.
In addition to NIIEFA, the Russian 6 MeV linear accelerator is being developed by another company of the State Atomic Energy Corporation NIITFA, JSC NIITFA, with a total funding of 250 million rubles. In addition to the head institute, a working group of specialists from Rosatom State Corporation, the National Medical Research Center of Radiology of the Ministry of Health, and the N.N. N.N. Blokhin, Moscow State University and MEPhI. It is assumed that the device will be released in small-scale assembly in 2022.
In the spring of 2019, Factory RTT LLC, a member of the R-Pharm group of Alexey Repik, began assembling linear accelerators of the American manufacturer of medical equipment Varian Inc in Dubna near Moscow. The company produces Unique, Clinaс and Halcyon models.
In February 2019, the Ministry of Health of the Russian Federation approved a list of medical equipment intended for re-equipping clinics under the oncological program of the Healthcare national project. The list includes 147 items of medical devices, including linear accelerators. The Ministry of Health recommended that the regions purchase medical products from domestic manufacturers at the expense of the national project budget with “equivalent technological characteristics.”