New technology being explored in Cleveland could give surgeons close to X-ray vision.
Cleveland-based surgical navigation startup Centerline Biomedical has for years been working to develop its Intra-Operative Positioning System (IOPS), a GPS-like system that provides 3D guidance during minimally invasive procedures.
Surgeons would have to look at a monitor to follow the guidance, but a new grant is offering Centerline and Cleveland Clinic researcher Karl West the chance to add HoloLens, a mixed-reality device from Microsoft, to the experience.
"So now, when I put HoloLens on, I can look at the patient and visualize or see the anatomy inside," said West, director of medical device solutions at Cleveland Clinic and staff member in the Lerner Research Institute's Department of Biomedical Engineering. "It's like having X-ray vision."
The Small Business Technology Transfer (STTR) award from the National Heart, Lung, and Blood Institute to test a "holographic GPS system for the operating room" is for nearly a quarter of a million dollars, according to a release from the Clinic.
The small grant comes as Centerline, a Cleveland Clinic spinoff company, is preparing to pursue U.S. Food and Drug Administration approval of IOPS. If approved, Centerline president Vinod Goel said he expects to take the device to market in the fourth quarter of this year. Adding the HoloLens application later wouldn't require additional FDA approval, he said.
"It's still the same IOPS," Goel said. "(It's) the question of how surgeons can see, visualize it. … We're not changing any components or anything. We're just giving surgeons additional tools to watch it."
West, who's also scientific adviser for Centerline and co-inventor of the IOPS technology, said the HoloLens capability on IOPS keeps the surgeon focused at the surgical site instead of having to look away at a monitor.
"So now if we use HoloLens, they actually will be able to look at their hands because they're actually looking at the surgical site, so all of the imaging is being projected at the surgical site," he said.
To date, Centerline has raised $13.3 million and is hoping to raise an additional $15 million in a Series B funding round in the coming months.
"And that will basically give us enough funding for market launch, for working on new applications, hiring more people, going through the next round of clinical research for the European market and all those kinds of activities," Goel said.
In the study funded by the STTR award, researchers will test the IOPS system in both a preclinical model and patient-specific, 3D printed models, using the technology to control and precisely place stent grafts, which are commonly used to treat aortic aneurysms by decreasing pressure and blood flow in the damaged parts of the aorta.
Stent grafts can commonly be misplaced. The current standard-of-care placement technique requires 2D X-ray fluoroscopy, which exposes patients, surgeons and caregivers to potentially dangerous radiation.
IOPS both limits radiation exposure and offers better visualization, said Dr. Ezequiel Parodi, staff vascular surgeon at the Clinic's main campus.
"It's a device that could let us be able to get some good, great images on the patient anatomy and be able to navigate … without using any radiation, or at least at the beginning minimizing the amount of radiation," said Parodi, who is one of a few physicians offering advice to Centerline.
Goel said the company has been demonstrating the IOPS technology at conferences and has gotten "tremendous" feedback.
"The reaction from surgeons has been just amazing — very popular technology," he said. "We're excited to get this through the FDA and get to the market."
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