FDA clears Elekta Integrity R1.1 treatment control system

13 February 2012 (Last Updated February 13th, 2012 18:30)

Elekta, a human care company, has received 510(k) clearance from the US Food and Drug Administartion for its Integrity R1.1 device, which has been found to improve the speed and performance of radiation therapy systems.

Elekta, a human care company, has received 510(k) clearance from the US Food and Drug Administration for its Integrity R1.1 device, which has been found to improve the speed and performance of radiation therapy systems.

The Integrity treatment control system comprises a three-tier safety system with continuously variable dose rate (CVDR) and interdigitation for Elekta's MLCi2.

The first Integrity safety tier records and verifies the prescription received from the MOSAIQ oncology information system and checks whether all linac parameters are set correctly.

The second tier of the device checks and controls MLC leaves, gantry, collimator and dose delivery throughout beam delivery, ensuring that all parameters are in the correct position and the right dose is being delivered.

The third tier, Guardian, supervises the proper operation of the other two tiers, verifying in real-time if the field currently being delivered matches the prescribed treatment parameters.

Previous clinical trials conducted at eight international centres showed that Integrity R1.1 has demonstrated safe reductions in treatment delivery times of as high as 30%.

The approval of the Integrity R1.1 system enables US medical centres to realise these treatment speed and safety benefits when Elekta begins delivery of the control systems.

Jonas Fontenot, physicist at Mary Bird Perkins Cancer Center, said: "During volumetric modulated radiation therapy [VMAT], Integrity constantly captures delivery parameters and sends them back to our MOSAIQ oncology information system, where they become part of the patient's electronic record."

"The additional dose rate options permit the control system to easily navigate complex dose modulation paths. Less variability in gantry speed smoothes VMAT arc motion, which also translates to reduced delivery times," Fontenot added.

Elekta's treatment control system supports CVDR, which enables the dose rate to be adjusted to its ideal value during delivery of both dynamic and VMAT prescriptions.

Integrity supports a complete range of delivery techniques, including intensity modulated radiation therapy (IMRT), VMAT and stereotactic applications, while providing maximum patient safety.