Brainlab to Roll Out New Mobile Intraoperative CT System

Following 510(k) clearance from the U.S. Food and Drug Administration (FDA), Brainlab is moving forward with the sale of the Airo Mobile Intraoperative CT. The FDA clearance was received by Mobius Imaging LLC the developer and manufacturer of Airo Mobile Intraoperative CT on Sept. 26, 2013.

Brainlab develops software-driven medical technology designed for less-invasive treatment. Core products are image-guided systems and software that provide real-time information used for surgical navigation and radiosurgical planning and delivery.
Founded in 2008, Ayer, Mass.-based Mobius Imaging develops and manufactures advanced imaging technologies. The Airo Mobile Intraoperative CT System is the company’s first commercial product and is distributed under an exclusive sales and service agreement with Brainlab.

“The market was ready for innovation in the surgical space from an advanced imaging perspective,” said Stefan Vilsmeier, president and founder at Brainlab, a German firm that has its U.S. base just outside Chicago, Ill. “Brainlab is now able to offer mobile CT imaging that can be used in combination with Curve Image Guided Surgery, helping to improve customer workflows while expanding clinical indications for intraoperative imaging. Access to real time information is transforming the surgical space and becoming integral to daily life in the O.R. Airo is a great example of how Brainlab is and will continue to maximize the impact of intraoperative information for surgical decision making and the well-being of patients.”

According to the company, Airo’s gantry size and flexibility allow facilities to offer high-quality imaging for a comprehensive range of clinical procedures while helping overcome conventional intraoperative limitations. An all-in-one solution, Airo offers the imaging quality of a diagnostic CT scanner, full Hounsfield soft-tissue imaging, with a scan volume of 51.2 x 100 centimeters.

“Airo has been designed from the ground up and incorporates valuable practitioner insights,” said Gene Gregerson, CEO, Mobius Imaging LLC. “Airo changes the game in terms of size, access and mobility in intraoperative imaging. We took an intelligent imaging approach, which means everything about the technology had to answer clinical need and be incorporated intuitively into everyday clinical practice. The 32-slice CT scanner offers an extra-large gantry opening of 107 centimeters while at the same time possesses an extra small footprint so it can move easily from O.R. to O.R. The extra slim patented Airo gantry design makes it suitable for intraoperative imaging, enabling access to the patient during scanning and allowing for flexibility in patient setup. This flexibility and mobility make Airo a valuable extension for numerous additional environments.”

An integrated O.R. table system from the medical technology division of Trumpf is the foundation for reproducible patient positioning with defined movement of the gantry relative to the patient. A variety of tabletops allow surgeons to accommodate a range of procedures, according to Brainlab

First shipments of the system are expected to begin at the start of 2014.