Claret Medical’s Montage Dual Filter system is poised to become a staple of transcatheter aortic valve implantation procedures if the company has anything to say about it.
In an original manuscript published by researcher Dr. Nicolas Van Mieghem he concluded that the Montage device captured "embolic debris" traveling to the brain in 75% of patients undergoing TAVI.
"During almost every TAVI procedure, significant debris is dislodged. The filter-based Montage 2 is the only way of capturing and getting this debris out of the body," Dr. Van Mieghem said in prepared remarks. "One may wonder, how long until embolic protection is used in every TAVI procedure?"
Dr. Van Mieghem’s research team enrolled 40 patients undergoing TAVI, capturing "liberated" debris in 30 of them. The captured debris varied in size from 0.55 mm to 1.8 mm in size and consisted of fibrin that was most likely from the native aortic valve leaflets or the aortic wall, according to the study.
Claret hopes to make itself an indispensable part of the growing TAVI market that medtech giants Edwards Lifesciences (NYSE:EW) and Medtronic (NYSE:MDT) are pioneering in the U.S. and internationally.
Claret’s Montage device is cleared for use in the European Union but is not available in the U.S.