Whale Imaging, Inc.’s marketing team believes its recently FDA 510(k) cleared G-Arm Duo imaging system has the chance to “revolutionize” the way surgeons carry out their surgical procedures. Company officials told OTW this is because, “compared to traditional C-Arm devices, our machine provides two planes of view at the same time. To accomplish this with C-Arms, it would require two machines, which can be very cumbersome and take up a lot of space in the operating room.”
“Within a few years, we expect the Duo to be a common fixture in orthopedics and spine departments across the U.S.” says Phil Posa, VP of the G-Arm Division. “It has many advantages over C-Arms for various procedures, so why add another C-Arm to your inventory when a G-Arm can accomplish so much more?”
Brian Duggan, the company’s marketing manager, said since most ORs use one C-Arm, doctors are forced to constantly move their device to take AP [anteroposterior] and lateral shots. “This takes up a lot of time and also could increase the risk of infection due to moving the device up and down breaking the sterile field. The G-Arm solves both these problems. Since G-Arm shows both AP and lateral perspectives at once, there is less need to reposition the device mid-surgery. This means procedures can be performed faster. Secondly, the device has potentially lower radiation dose because the operator can take fewer corrective exposures. And finally, by eliminating the need to reposition the device during surgery, there is less disruption of the sterile field, which can reduce risk of infection.”
The ability to fire two x-ray beams asynchronously provides the customer with bi-lateral video and images, giving the user a more comprehensive picture than a traditional C-arm. G-Arm utilizes this X-Beam technology, as well as iC-Clear algorithms. Engineers at Whale made the Duo compatible with all surgical tables.
In 2014, the company won one of Orthopedics This Week‘s Best New Spine Technology Awards for their G-Arm system.
510(k) Submission
The company made its 510(k) submission to the FDA in November 2016. That submission states the following:
There are two sets of X-ray tube assemblies and Image Intensifiers which are perpendicularly distributed on the G-Arm, acting as two sets of vertical X-ray source and receptor systems and providing fluoroscopy image of the patient. The two sets of X-ray tube assemblies and Image Intensifiers can operate simultaneously and separately.
The B6 [G-Arm Duo] can be operated in two different modes: Continuous fluoroscopy and Pulse fluoroscopy. Each of these two modes can be operated either manually or automatically.
So, the fluoroscopy mode can be categorized by the X-ray emitting pattern or by the control method of the imaging process, which consequently divides a fluoroscopy mode into the following four major types: Automatic Continuous Fluoroscopy, Automatic Pulse Fluoroscopy, Manual Pulse Fluoroscopy, Manual Continuous Fluoroscopy.
Besides the above four fundamental fluoroscopy modes, the G-Arm system offers two other features: ER Fluoroscopy and Half Dose Fluoroscopy (modifies only Automatic Pulse Fluoroscopy and Automatic Continuous Fluoroscopy modes).
