Transcatheter aortic valve replacement is advised for use in high, extreme, and intermediate risk patients experiencing severe aortic stenosis. At present, its efficiency is being validated in low-risk patients. The valve replacement processes can result in the release of debris into the aorta from where it can go to the brain and result in blockages, thus causing neurocognitive problems, peripheral issues, and strokes. It has been reported that almost 90% of patients who undertake transcatheter aortic valve replacement can exhibit anomalies, designated as “silent strokes,” when they are neuroimaged after the process.
Now, a privately owned medical device organization, Innovative Cardiovascular Solutions, preparing new ways out for embolic safety during transcatheter aortic valve replacement, has declared about their first successful European clinical cases with the use of EMBLOK™ Embolic Protection System in participants undergoing transcatheter aortic valve replacement procedures.
The EMBLOK system is the foremost circumferential aortic filter developed to completely capture and avoid embolic debris from traveling to the brain and other vasculature while the transcatheter valve processes. On activation, the catheter opens up to expose a 125 µm filter inside the aorta that covers the vessel permitting blood to travel through. While opened up, the filter grabs debris that can form an obstruction in the brain. As the catheter is radio-opaque, it can be visualized during the process to ensure it is in the accurate position.
CEO and Co-founder of Innovative Cardiovascular Solutions, R. Kevin Plemmons, said, “We are extremely optimistic that the system surpassed the expectations of the physician and functioned fine in its first clinical events. Cardiovascular surgeons and interventional cardiologists who undertake left heart structural processes insist the optimum care for the patients. We are content to fulfill this requirement with the former embolic device developed to provide full collection as well as circumferential protection.”
At present, the EMBLOK device is accessible only for investigational use and not yet granted permission for its sale. The company wishes to ultimately get a grant for the system in Europe. The company also intends for a trial in America.
We hope the company gets the approval and continues to help patients to improve their quality of life. What is your opinion regarding the same?