The first European clinical cases using the Emblok Embolic Protection System (Innovative Cardiovascular Solutions) in patients undergoing TAVI (transcatheter aortic valve implantation) procedures have taken place in Italy. The cases were performed by Azeem Latib and Matteo Montorfano under the direction of Antonio Colombo at San Raffaele Hospital in Milan, Italy.
TAVI is indicated for use in intermediate, high, and extreme risk patients with severe aortic stenosis. Its efficacy is currently being tested in low risk patients. However, numerous studies confirm that these procedures are associated with increased risk of neurological events as compared to conventional surgery, due to the embolic debris that enters the cerebral, abdominal and distal vasculature during the procedure. The Emblok system is the first circumferential aortic filter designed to fully capture and prevent embolic debris from reaching the brain and other vasculature during transcatheter valve procedures.
“The Emblok system is intended to provide complete cerebral protection during valve implantation and is very easy to position, deploy and retrieve,” says Latib. “It is the most intuitive filter I have ever used,” adds Montorfano. Colombo further comments, “Of all the filters, this is the one I like the most, it is very straightforward to use.”
The company’s multicentre non-randomised feasibility study will evaluate subjects with severe native aortic valve stenosis who meet the commercially approved indications for TAVI. Study endpoints will include acute cerebral embolic burden and major adverse cardiac and cerebrovascular events (MACCE) at 30 days.
The Emblok system is currently available for investigational use only and is not approved for sale.