Microsulis Medical has obtained the US Food and Drug Administration's (FDA) approval for upgraded version of its Accu2i pMTA applicator, designed for use as part of the company's Acculis Microwave Tissue Ablation (MTA) system.
The Accu2i MTA system also includes a Sulis VpMTA generator, MTA applicator, MTA temperature probes, local control station (LCS) as well as a trolley.
The minimally invasive applicator, which is available in 14cm, 19cm and 29cm lengths, is a 1.8mm shafted disposable saline-cooled needle which operates at 2.45GHz to create a near spherical coagulation up to 5.6cm in six minutes at maximum power.
The upgraded version of the applicator includes a refined casing which allows the user to see the coolant flowing through the applicator and a optically clear moulded handle with ridged contact points.
The coolant spike tubes of the applicator have also been color coded to provide a visual aid for ease of manufacture.
In addition, the Accu2i pMTA cartridge that connects the applicator to the LCS has been given an ergonomic makeover and its parts have been revised to further improve the coolant flow through the system and simplify the build.
The changes also allow Microsulis to scale-up production output to satisfy its expanding customer base, according to the company.
Microsulis Medical CEO Stuart McIntyre said to keep up with demand and fuel the growth of the technology, it was necessary to introduce production and design solutions to allow large volume, scalable, high-quality manufacturing.
"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," McIntyre added.
