05/14/2020
Cleveland Clinic Spinoff Company Reaches Latest New Business Benchmark
The Cleveland Clinic spinoff company Centerline Biomedical, which commercializes an endovascular (in the blood vessels) surgery navigation technology called the Intra-Operative Positioning System (IOPS), has received pre-market clearance from the U.S. Food & Drug Administration, reaching and surpassing a major business development benchmark and paving the way for a full launch of the technology later this year.
The company’s latest achievement means more resources can be put towards marketing the IOPS technology, making sure surgeons and patients are aware of its benefits, notes Department of Biomedical Engineering’s Karl West, MS, inventor of the IOPS technology and member of Centerline Biomedical’s Scientific Advisory Board.
The standard method of performing endovascular procedures relies on x-ray fluoroscopy for guidance. Limitations of fluoroscopy include the fact that it does not allow for visualization of soft tissues, provides two-dimensional grayscale imaging only, and—probably its greatest disadvantage—exposes patients and operating room staff to potentially dangerous levels of radiation.
The IOPS technology offers full-color, 3D views of the vascular system, which greatly improves a clinician’s perspective during an endovascular procedure. After a model of the patient’s anatomy is created from a CT scan, the IOPS tracking system registers the 3D model to the patient intraoperatively and couples that to the electromagnetic tracking. The endovascular procedure is performed in the same manner as is done with fluoroscopy, but now, with IOPS, the physician has 3D visualization and real-time tracking capabilities to navigate within the vasculature.
“One of our primary motivations in developing the IOPS technology was to reduce the level of radiation and danger to both patients and operating room staff,” says West.
Other improvements offered by IOPS are that it can be used in other areas of the human vascular system, and the catheters and guidewires are equipped with sensors, which improves the physician’s ability to, for instance, place a stent within an artery. In addition, the technology can shorten the time it takes to do a procedure. “This gives us a new way to visualize, guide, and control the procedure,” says West, who likens the IOPS to a GPS device.
A newer development, thanks to a grant from the National Heart, Lung, and Blood Institute, is the potential use of the Microsoft HoloLens with the IOPS technology. When wearing the HoloLens, the physician will be able to look directly at his or her hands and the patient, rather than at a monitor (away from the patient), while performing a procedure. Centerline Biomedical will use the grant to test IOPS for the placement of stent grafts to treat aortic aneurysms.
