Microsulis reports that the groundbreaking Accu2i pMTA system for destroying unwanted tissue and used in the treatment of liver and other cancers now carries an impressive range of electrical safety standards. The Accu2i is CE-marked and carries FDA 510(k) clearance and so is cleared for electrical safety and performance with the internationally recognised 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. This is especially important for such a high powered device as the Accu2i. Furthermore, 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.
“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 groundbreaking performance of the device reflects the extensive testing the device has undergone to the highest standards around the world.”
Mike Neal, Operations Director of Microsulis, commented, "IEC 60601-1 is an international safety benchmark and a critical part of the requirements for the CE marking and FDA clearance - both of which we received earlier this year. However, we also recognise that it is important to acknowledge all international safety standards relating to the very exacting performance required by these high powered microwave devices. To that end, the Accu2i pMTA system carries the additional significant IEC 60601-2-6 microwave and IEC 60601-2-2 surgical and safety standards, and we have worked hard to ensure that the system meets the safety requirements of all the markets we will be entering."
The Accu2i pMTA is the most powerful tumour ablation system currently available, combining extreme 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. Its launch followed two years of extensive clinical use and evaluation in major centres around the world mainly treating liver and lung cancers.
Stuart McIntyre, CEO of Microsulis added, "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 groundbreaking performance of the device reflects the extensive testing the device has undergone to the highest standards around the world."
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