Denmead, England-based Microsulis Medical Ltd., a medical device maker focusing on minimally invasive soft tissue ablation, won FDA clearance for its Accu2i pMTA percutaneous microwave ablation device.
The next-generation device features an ergonomic redesign with ridged contact points, a more tactile feel and features which allows the user to see the coolant flowing through the applicator, according to the press release.
"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," CEO Stuart McIntyre said in prepared remarks. "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."
The Acculis MTA system has been CE Marked since 2010 and distributed globally, except in the U.S., the company said.
The FDA in 2010 cleared the initial high-power, high-frequency 2.45GHz saline-cooled needle as part of the Acculis MTA system for the coagulation of soft tissue.
Microsulis last August opened a $15 million funding round to support global commercialization of its Accu2i pMTA percutaneous microwave ablation device.
