Innovative Cardiovascular Solutions (ICS) has announced the success of its first European clinical cases using the next generation of the Emblok embolic protection system in patients undergoing transcatheter aortic valve implantation (TAVI). The procedures were performed by Federico De Marco at IRCCS Policlinico San Donato, Milan, Italy.
TAVI procedures have experienced rapid growth over the past several years as the indication has broadened to include lower risk patients, and as more institutions have adopted procedures. Despite recent innovations including the reduction of TAVI device profiles, and enhanced procedural techniques, the risk of clinical complications associated with embolic debris liberated into the vascular circulation remains.
The Emblok embolic protection system is designed to provide circumferential aortic coverage to capture and remove embolic debris released during TAVI procedures, preventing debris from reaching cerebral and peripheral vascular circulation.
“The Emblok system performed exceptionally well. We experienced smooth insertion and precise filter positioning in patients with challenging anatomy. We were able to successfully pass interventional devices, including the TAVI system beyond the filter without any device interaction enabling complete embolic protection during the duration of the TAVI procedure,” said De Marco. “We are extremely enthusiastic with the initial results of the Emblok system.”
“Although last year created many global challenges, we are encouraged with our continued progress and the clinical experience with our next generation of Emblok,” said R Kevin Plemmons, co-founder and CEO of Innovative Cardiovascular Solution. “We anticipate that 2021 will be an exceptional year for ICS as we launch our US IDE clinical study and continue to demonstrate the performance of the Emblok embolic protection system, highlighting the clinical advantage of complete embolic protection.”