FDA Clears Microsulis Medical Limited's Upgraded Microwave Ablation Device
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. Following two years of global distribution, and in response to customer feedback and growing product demand, Microsulis has updated the device’s design and manufacturing process. Improvements include a refined optically clear moulded handle and improved connection cartridge.
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.
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.”
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. Clinicians will notice the casing is both more pleasing to handle and 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.
An animation of the new Accu2i pMTA applicator is available to view on YouTube..
About Microsulis Medical Ltd
Microsulis Medical is a specialist medical device company with market leading solutions in microwave ablation. The company’s products deliver significant technological and clinical advances to physicians and patients in minimally invasive, soft tissue ablation.
The Acculis MTA system was CE Marked in February 2010 and 510(k) cleared by the U.S. Food and Drug Administration in August 2010. It is distributed globally, with the exception of the US, by AngioDynamics: www.AngioDynamics.com.
More information is available at www.microsulis.com.
The FDA has cleared the Acculis MTA system for the coagulation of soft tissue. The Acculis MTA system has not been cleared or approved for any specific treatments or therapies of a specific disease or condition that may be mentioned in this press release.
Contact:
Microsulis
For more information or
a hi-res image of the Accu2i pMTA applicator
Claire Hall
Head of Marketing and Communications
+44 (0)7766 365897
claire.hall@microsulis.com