KALAMAZOO, Mich., Dec. 18, 2018 /PRNewswire/ -- Innovative Cardiovascular Solutions, LLC (ICS), a privately-held
The Emblok system is designed for use in Transcatheter Aortic Valve Replacement (TAVR) and other structural heart procedures where embolic protection is required. As the number of these procedures grows, the clinical need for a device that is suitable for a variety of patient anatomies and offers complete capture while removing the liberated embolic debris also grows.
"We are pleased with the continued support from our current investors as we advance the clinical evaluation of the Emblok system," said R. Kevin Plemmons, co-founder and CEO of ICS. "Our team has made significant progress refining the system's design and preparing for the U.S. pivotal trial. We are in discussions with the U.S. Food and Drug Administration (FDA) to finalize the pivotal trial design and look forward to demonstrating the Emblok system's clinical impact during structural heart procedures."
The Emblok system is the world's first and only embolic protection device designed to offer complete circumferential aortic collection while protecting the cerebral, abdominal and peripheral vasculature from liberated embolic debris. In addition, the Emblok system features an integrated 4 Fr radiopaque pigtail catheter which provides the physician constant visualization while eliminating the need for unnecessary dye injections to verify positioning. The entire system is 11 Fr and allows two devices – the embolic filter and pigtail catheter – to be deployed through a single femoral puncture site.
The Emblok system is available for investigational use only and is not approved for sale.
About Innovative Cardiovascular Solutions (ICS)ICS is developing novel solutions that offer full capture and protection from embolic material released during left-sided heart procedures. With the first product, the Emblok Embolic Protection System, ICS's goal is to improve patient quality of life and lower overall healthcare costs associated with embolic risks. To learn more, please visit www.emblok.com.
Media Contact: R. Kevin Plemmons CEO(269) 599-6572
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SOURCE Innovative Cardiovascular Solutions, LLC
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