Innovative Cardiovascular Solutions, a company based in Grand Rapids, Michigan, has announced a clinical trial of their Emblok Embolic Protection Catheter in Europe. The catheter is designed to be used during transcatheter aortic valve replacements. Valve replacement procedures can result in debris being released into the aorta, which can then travel to the brain and cause blockages, potentially resulting in strokes and neurocognitive issues, as well as peripheral problems. The company reports that up to 90% of patients who undergo transcatheter aortic valve replacement can display abnormalities when they are neuroimaged after the procedure, which has been described as “silent stroke”.
The Emblok catheter is designed to be deployed during the valve replacement procedure. When activated, it opens up inside the aorta to unveil a 125 micron filter that spans the vessel, allowing blood to pass through. While unfurled, the filter catches debris that could form a blockage in the brain. The catheter is radiopaque and so can be imaged during the procedure to make sure it is in the correct location.
The company just recently announced the successful first use of the device in patients. This latest trial will see patients with aortic stenosis undergo transcatheter aortic valve replacement with the Emblok catheter in place. An MRI scan before and after the procedure will be used to check for embolic debris in the brain. The company hopes to eventually get approval for the device in Europe and there are also plans for a trial in America.
Here’s a video demonstrating the functionality of the Emblok:
Product page: Emblok Embolic Protection System…