The FDA has given Akesis the green light to move forward with the sale of its Akesis Galaxy RTi, an advanced gamma stereotactic radiosurgery system.
The scanner is equipped with continuous 360 degree rotational technology and real-time, in-line CBCT + kV/kV imaging that helps it perform automated intrafractional skull tracking and corrections.
"For the first time, the patient can be imaged and treated without time-consuming patient movements between imaging and treatment positions. This dramatically enhances the speed and accuracy of the whole procedure," Tim Prosser, director of Global product management at Akesis, told HCB News.
Akesis Galaxy RTi is set up on a rigid ring gantry at the treatment place that eliminates the need to move patients or stop treatment to image them. This, and the fact that the treatment and imaging beams are designed to coincide with one another, reduces time spent on the table by the patient.
The system is equipped with a compact source drawer of 30 gamma sources, combined with four collimators and one blocking position, which all together help shape dose distribution. Its rotational delivery allows it to be more flexible than traditional, fixed sector-based delivery in how it shapes dose distribution. In addition, the source drawer approach decreases the total cost of ownership and decreases downtime from weeks to days when having to replace the source.
Prosser says patients who would gain the most from the system are those "with medical conditions like Trigeminal Neuralgia, Arteriovenous malformations (AVMs), Acoustic Neuromas, Brain Metastasis and other cancerous tumors, who would like to avoid invasive surgery."
Approval of the system follows that of the Akesis Galaxy RTx
in February 2020. Equipped also with continuous 360 degree rotational technology and flexible in dose distribution shaping, the <0.5mm accuracy of the system enables strong dose fall-off and makes it potentially better for sparing organs at risk. Both are based on isometric design principles that have been published in more than 2,000 peer-reviewed papers for Co-60 based radiosurgery and are successors to the Akesis Galaxy.
Akesis Galaxy RTi is expected to be attractive among institutions with high-throughput workflows, small cancer centers and value-based reimbursement models.