A Medical Device Daily
Matching its size and diversity of development, GE Healthcare (Waukesha, Wisconsin) unveiled a variety of new products and agreement initiatives last week at the annual meeting of the American Academy of Orthopaedic Surgeons (Rosemont, Illinois) in Washington.
The company reported FDA clearance of a new mobile X-ray system to provide greater confidence in performing complicated surgical procedures. The new system, called OEC Fluorostar, is a digital C-arm designed to provide fluoroscopic images of the patient during diagnostic, surgical and interventional procedures. The clearance includes a new feature within OEC Fluorostar, which the company calls "a breakthrough for visual identification of spot-film images."
Lewis Dudley, leader of GE Healthcare's Surgery unit, said, "OEC Fluorostar provides imaging in multiple applications and for versatile clinical environments. The new Fluorostar continues GE's interventional imaging leadership."
The company said physicians like OEC Fluorostar's compact design and flat-panel display monitor because it enables them to maneuver in and out of operating theaters. The OEC Fluorostar also has been designed to simplify workflow, with access to all functions from either the left- or right-side touch screen interface. Single-level menu operations allow users to quickly move through menus by simply touching options on-screen, eliminating the need of keyboard or mouse, GE said.
GE said that clinical applications for OEC Fluorostar may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, stone localization, critical-care and emergency room procedures.
The company also introduced a new technology for surgical navigation that enables the ability to provide visualization during minimally invasive spine procedures. The navigated instrument, the NAV Axcess Needle, is used with ElectroMagnetic surgical navigation – a technology that enables surgeons to track their hand instruments as a virtual tool image superimposed over X-ray images.
The NAV Axcess Needle is designed to enable navigation and visualization of the commonly used surgical needle, facilitating spinal surgery procedures that are now being accomplished through small percutaneous and "keyhole" incisions, according to the company. It can be used with real-time tracking ability of the GE InstaTrak 3500 Plus and OEC FluoroTrack 9800 Plus surgical navigation systems for percutaneous guidewire insertions. As a surgical needle, the NAV Axcess Needle facilitates guidewire placement for percutaneous pedicle screws and guidewire placement for procedures involving treatment of vertebral compression fractures.
"The NAV Axcess Needle provides the surgeon with the enhanced ability to see into bony anatomy, while simultaneously decreasing the number of X-ray images required to do so," said Laura King, general manager of interventional, cardiology and surgery at GE Healthcare. "Our clinical partners have told us that this new technology is key to improving the surgeon's orientation between anatomy and instrument position."
GE also reported a new agreement with Excelsior Orthopaedics (Amherst, New York), a comprehensive musculoskeletal center in western New York State, to help provide early diagnosis and treatment of musculoskeletal diseases and disorders. The Center of Excellence said it will use an interdisciplinary approach to offer an integration of services for improved convenience and care.
GE will supply the new specialty campus, scheduled to open in March, with information technologies and clinical imaging solutions, including digital X-ray, MRI and picture archiving communication systems.
Excelsior's newest facility includes the Buffalo Surgery Center, one MRI suite, two X-ray rooms, physical and occupational therapy rooms and a half-basketball court. The eight-physician group specializes in sports medicine, hand and upper extremity surgery, pediatric orthopedics, total joint replacement, foot and ankle surgery, reconstructive surgery, and trauma and fracture care. The group forecasts 52,000 orthopedic visits and 5,600 surgeries provided during its first year in the new facility.
In a new product demonstration at AAOS:
Paul McAfee, MD, an orthopedic surgeon at the Scoliosis and Spine Center (Towson, Maryland), led two studies on disc replacements: one on replacements in the lumbar region using the recently FDA-approved Charit disc manufactured by DePuy Spine (Raynham, Massachusetts), a division of Johnson & Johnson (New Brunswick, New Jersey), and one on those in the cervical region.
McAfee's study on the Charit disc found that patients who received that type of disc replacement had an 82.5% increase in their flexion and range of motion two years after surgery, compared to a decreased range of motion for all patients who received spinal fusions; the Charit patients also had significantly better restoration of disc height.
"The great thing about disc replacements is that they allow us to preserve the motion in the patient's spine," McAfee said. "Treatments like spinal fusion immobilize part of the spine, which causes stress on the adjacent levels of motion. Also, if you need to fuse multiple vertebrae, recovery time and the chance of complications increase. But with disc replacement, you don't have those problems. It's not right for every patient, but if you follow the clinical indications, it can be an excellent option."
From his study on porous-coated motion discs used in the cervical region, McAfee noted less invasiveness and shorter recovery time. Some patients were able to have the surgery on an outpatient basis, and 87% of working patients were able to return to their jobs within six weeks.