MILAN, March 2, 2021 /PRNewswire/ — Innovative Cardiovascular Solutions (ICS), a privately held medical device company developing the most complete comprehensive solution to embolic protection for structural heart and vascular interventions, announced today the success of its first European clinical cases using the next generation of the EMBLOK™ Embolic Protection System in patients undergoing transcatheter aortic valve replacement (TAVR). The procedures were performed by Dr. Federico De Marco at IRCCS Policlinico San Donato in Milan, Italy.
Transcatheter aortic valve replacement (TAVR) procedures have experienced rapid growth over the past several years as the indication for TAVR has broadened to include lower risk patients, and as more institutions have adopted procedures. Despite recent innovations including the reduction of TAVR device profiles, and enhanced procedural techniques, the risk of devastating clinical complications associated with embolic debris liberated into the vascular circulation remains. The EMBLOK™ Embolic Protection System is the first device designed to provide complete circumferential aortic coverage to capture and remove embolic debris released during TAVR 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 TAVR system beyond the filter without any device interaction enabling complete embolic protection during the duration of the TAVR procedure,” said Dr. 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.”
About Innovative Cardiovascular Solutions (ICS)
Innovative Cardiovascular Solutions is privately held company pioneering novel solutions for embolic protection during structural heart and vascular interventions.
The EMBLOK system is the first embolic protection device designed to offer full circumferential aortic coverage to protect both the cerebral and peripheral vasculatures by capturing and removing embolic debris during minimally invasive transcatheter procedures. Additionally, the EMBLOK system has an integrated 4Fr radiopaque pigtail catheter which provides physicians with constant visualization, while eliminating the requirement for frequent contrast injections to verify device positioning. The complete EMBLOK system, including the embolic filter and pigtail catheter may be delivered through a single femoral access location.
More information is available at www.emblok.com.
The EMBLOK™ Embolic Protection System is not yet commercially available and is intended for investigational use only.
R. Kevin Plemmons
CEO, Innovative Cardiovascular Solutions
SOURCE Innovative Cardiovascular Solutions, LLC