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NIH Funds Augmented-Reality Endovascular System

Heart, circulation system

(Bryan Brandenburg, Wikimedia Commons)

12 Sept. 2019. A grant from National Institutes of Health is funding a system using augmented reality and holography to improve minimally-invasive repair of blood vessels. National Heart, Lung, and Blood Institute is providing $1.5 million over two years to Centerline Biomedical Inc. in Cleveland, Ohio for its technology to boost the speed and accuracy of placing stent grafts to repair aneurysms with minimally-invasive surgery.

Aneurysms are bulges in blood vessels that occur when the blood vessel wall weakens and can rupture. In the chest cavity, aneurysms can develop from a disorder in the aorta, the main artery from the heart that pumps blood to the rest of the body. Endovascular surgery is a newer approach to repairing aortic aneurysms that uses a catheter, rather than open surgery, to reach the repair site with a stent for grafting into the blood vessel wall to provide more support.

Centerline Biomedical develops endovascular systems to repair aneurysms, with its main product called the Intra-Operative Positioning System or IOPS. The company is spun-off from the Cleveland Clinic that conducted the initial work on IOPS, with Vikash Goel, an inventor of the system, co-founding the company. The other IOPS inventor, Karl West, is director of medical device solutions at the Cleveland Clinic, and a scientific advisor to the company.

IOPS, says Centerline, offers a clearer and more detailed view of the patient’s chest cavity than the current X-ray fluoroscopy used for endovascular surgery. The company says X-ray fluoroscopy provides two-dimensional grayscale images of the patient’s blood vessels, while IOPS gives vascular surgeons a color and three-dimensional image. As a result, says Centerline, IOPS can make placement of stent-grafts in blood vessels more precise, and reduce the need for continuous X-ray fluoroscopy and contrast dyes. In July, the company received clearance from FDA to market IOPS in the U.S.

The NIH award funds enhancements to IOPS with three-dimensional guidance, navigation, and control for endovascular blood vessel repair. The enhancements use holograph images projected on a surgeon’s headset, and data projected in the surgeon’s field of view with augmented reality. An initial NIH grant funded a prototype device for IOPS that in tests with lab models reduces procedure time by more than half, improves orientation accuracy by 42 percent, and eliminates the need for X-rays and contrast dyes.

In the next phase of the project funded by the new grant, Centerline and the Cleveland Clinic will develop a working 3-D IOPS guidance, navigation, and control module for usability testing by three medical centers. The company also plans to test the enhanced IOPS on lab models with stent grafts from at least two manufacturers. If those usability and lab tests prove successful, Centerline and the Cleveland Clinic will then seek approval for a clinical trial to assess the system’s safety and verify its operational improvements over current methods.

“Adding this piece to our technology will have a multiplicative effect on the value to the clinician,” says Goel in a company statement. “We believe it will improve patient outcomes right away, and the strategic opportunities it opens for Centerline will make the IOPS technology much more impactful.”

The award was made under NIH’s Small Business Innovation Research, or SBIR, program that sets aside a portion of its overall research funding for small U.S.-based companies with science-based products. NIH says it invests more than $1 billion in SBIR and related Small Business Technology Transfer awards.

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