The US Food and Drug Administration (FDA) has approved Microsulis Medical's upgraded version of minimally invasive microwave tissue ablation applicator.
The Accu2i pMTA applicator is designed for use as part of the company's Acculis Microwave Tissue Ablation (MTA) system, which also includes a Sulis VpMTA generator, MTA applicator, MTA temperature probes and local control station (LCS), as well as a trolley.
Available in 14cm, 19cm and 29cm lengths, the Accu2i pMTA applicator 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 that 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 colour 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 coolant flow 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 2.45GHz microwave ablation, used for volume tissue coagulation of soft tissues, provides clinicians with more options 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," McIntyre said.
"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."