FDA Clears Microsulis’ Microwave Ablation Device Upgrades

In short

UK device company Microsulis Medical Ltd, specialist in minimally invasive, microwave ablation technology for the coagulation of soft tissue, has received FDA clearance for its upgraded Accu2i pMTA applicator.

Background

The initial version of the single, high-power, high-frequency 2.45GHz saline-cooled needle was cleared for use in the US as part of the Acculis MTA system in 2010. According to Microsulis, following two years of global distribution, and in response to customer feedback and growing product demand, it has updated the device’s design and manufacturing process.

Improvements include a refined optically clear moulded handle and improved connection cartridge. Clinicians will notice the Accu2i pMTA applicator’s handle has undergone an ergonomic redesign, with ridged contact points and a more tactile feel. The optical grade clear applicator casing has been refined to allow the user to see the coolant flowing through the applicator. The coolant spike tubes have also been colour-coded to provide a visual aid for ease of manufacture.

The Accu2i pMTA cartridge, that connects the applicator to the Local Control Station (LCS), has also been given an ergonomic makeover. Microsulis says clinicians will find the casing more pleasing to handle and more robust in design, making it easier to use. Within the cartridge, parts have been revised to further improve the coolant flow through the system and simplify the build.

The company says clinicians will continue to get the same results from Mark 2 of this market leading, minimally invasive product, while benefiting from improvements in the look and feel of the device. The changes also allow Microsulis to scale-up production output to satisfy its expanding customer base.

Company comments

Stuart McIntyre, CEO of Microsulis Medical Ltd, said: “2.45GHz microwave ablation is becoming the new global standard for volume tissue coagulation, giving clinicians options for patients that were not possible with radiofrequency ablation technology.

“To keep up with demand and fuel the growth of this technology, it was necessary to introduce production and design solutions to allow large volume, scalable, high-quality manufacturing. Hence we have introduced a new improved design that has now received marketing clearance from the US Food and Drug Administration.

“The product continues to be available for global distribution and, with this clearance, we look forward to offering this new applicator to our many US based customers.”

Source: Microsulis Medical Ltd.