Innovative Cardiovascular Solutions Begins European Study of the Emblok Embolic Protection System
March 15, 2017—Innovative Cardiovascular Solutions (ICS) announced the successful first European clinical cases using the company's Emblok embolic protection system in patients undergoing transcatheter aortic valve replacement (TAVR) procedures. The Emblok system is currently available for investigational use only and is not approved for sale, advised the company.
According to ICS, the Emblok system is a circumferential aortic filter designed to fully capture and prevent embolic debris from reaching the brain and other vasculature during TAVR procedures. The Emblok system incorporates an integrated 4-F radiopaque pigtail catheter that provides constant visualization, while eliminating the need for constant dye injections to verify positioning. The entire system is 11 F and allows two devices (ie, embolic filter and pigtail catheter) to be deployed through a single puncture site.
The company noted that the Emblok device is being evaluated in the company's multicenter nonrandomized feasibility study that will enroll patients with severe native aortic valve stenosis who meet the commercially approved indications for TAVR. Study endpoints will include acute cerebral embolic burden and major adverse cardiac and cerebrovascular events at 30 days.
The first cases were performed by Azeem Latib, MD, and Matteo Montorfano, MD, under the direction of Antonio Colombo, MD, at San Raffaele Hospital in Milan, Italy. In the company's press release, Dr. Latib commented, "The Emblok system is intended to provide complete cerebral protection during valve implantation and is very easy to position, deploy and retrieve." Dr. Montorfano added, "It is the most intuitive filter I have ever used." Dr. Colombo also stated, "Of all the filters, this is the one I like the most, it is very straightforward to use."