Microsulis has reported that the Accu2i pMTA system for destroying unwanted tissue and used in the treatment of liver and other cancers carries a range of electrical safety standards.
Microsulis said that the Accu2i is CE-marked and carries FDA 510(k) clearance and so is cleared for electrical safety and performance with the internationally recognized standard IEC 60601-1 for electrical safety.
In addition, the system is currently cleared with the international safety standard IEC 60601-2-6, which is a particular requirement for the safety and specification for microwave therapy equipment.
The Accu2i pMTA is the tumour ablation system currently available, combining ease of use with the widest range of clinical applications.
The device is a single high power high frequency 2.45GHz microwave needle that can address tumours over 5cm in size in just 6 minutes, and is therefore between 3 to 10 times faster than other systems, Microsulis said.
The Accu2i carries IEC 60601-2-2 a requirement for the safety of high frequency surgical equipment including microwave systems, and Microsulis is on track toward applying the ETL mark by the end of the year.
Microsulis CEO Stuart McIntyre said that increasing numbers of clinicians around the world are adopting the radically improved performance and ease of use of the Acculis system, moving away from older radiofrequency ablation systems.
“The performance of the device reflects the extensive testing the device has undergone to the highest standards around the world,” McIntyre said.