Start-up firm ‘breaks away’ from standard C-arm technology

Breakaway Imaging, a three-year-old manufacturer of medical imaging systems based in Littleton, MA, is bringing 3D visualization to the operating room. In addition to traditional 2D fluoroscopy, the company's first product to reach market offers orthopedic and spine surgeons a critical axial view of anatomy.

"Advanced and minimally invasive surgical procedures, especially spine surgery, are axially based by nature. However, the 2D imaging that is available with conventional C-arm imaging systems makes it difficult for surgeons to assess the placement of their instrumentation with respect to the axial plane," said Rich Grant, Breakaway CEO. "In addition to traditional fluoroscopy, our system provides 3D intraoperative views."

The O-Arm system received 510(k) premarket approval from the FDA in May (DI SCAN 6/27/05) for use in orthopedic applications. The system also has been approved for interfacing with image-guided surgery systems. Although the initial application of the O-Arm is for orthopedics, the platform is easily adapted for mobile imaging in the hospital, trauma assessment in the emergency department, or imaging in the intensive care unit, Grant said.

Breakaway is launching the O-Arm at the annual meeting of the North American Spine Society in September. As a small company with limited resources, Breakaway is focusing on orthopedic surgery, more specifically spine surgery. But there are other potential future applications for the platform, Grant said, including vascular surgery.

The O-Arm imaging system operates in three distinct imaging modalities: traditional fluoroscopy, multiplanar fluoroscopy, and 3D volumetric imaging. It has two parts. The trademarked O-Arm has about the same footprint as a C-arm, but it has a unique cantilever-mounted circular gantry that enables a section to telescope for lateral patient access. The 90° distal end of the gantry telescopes back onto itself to create a "C" shape while the patient is being positioned. During imaging, the telescoping section of the gantry is closed to form an "O" shape, Grant said.

The system uses a rectangular digital flat-panel x-ray detector that increases dynamic range and spatial resolution, eliminating the distortions associated with image intensifiers that are commonly used in C-arms.

The O-Arm uses multi-axis precision robotics to acquire different views during examinations. Standard C-arms are mechanical systems that must be manually reoriented when switching from an anterior-posterior to a lateral or oblique view. The O-Arm system allows storage of these positions for a patient before imaging in other planes and then automatically returns to the stored positions with the push of one button.

Breakaway, which has a total of 13 full-time employees, is headed by a team of three founders experienced in computer-assisted surgery systems. Grant spent two decades working with medical products, most of the time at Hewlett-Packard. Chief technology officer Gene Gregerson is a former researcher in CT reconstruction techniques at Massachusetts Institute of Technology Lincoln Laboratories and R&D manager for Visualization Technology, a developer of electromagnetic-based image-guided surgery systems that was acquired by GE Healthcare in 2002. When Norbert Johnson, vice president for R&D, was with Cortek, he developed a robotic welding system for hardware devices that converts electrical signals into photos. He is now developing products to treat chronic back pain.

"The three founders of the company have developed a deep understanding of the issues facing orthopedists and neurosurgeons, especially those arising due to the lack of a volumetric imaging capability," Grant said. "We set out to develop a unique imaging system truly designed for surgery, to give them the intraoperative visualization they need."