Claret Medical, Inc. Announces Publication of the First Clinical Research on the Frequency and Composition of Embolic Debris Captured during TAVR
SANTA ROSA, Calif., May 20, 2013 /PRNewswire/ -- Claret Medical, Inc. announced the publication of an original manuscript by Dr. Nicolas Van Mieghem et al., Histopathology of Embolic Debris Captured During Transcatheter Aortic Valve Replacement. Published ahead of print in Circulation, May 7th this research is the result of a collaboration between Erasmus Medical Center, Rotterdam, the Netherlands and the pathology team of Dr. Renu Virmani of the Cardiovascular Pathology Institute, Gaithersburg, Maryland.
This is the first time any research has reported the frequency and composition of debris captured in a series of patients who underwent TAVR combined with the use of the Claret Montage Dual Filter System. The results, from the 40 patient series, found visible debris in 75% of patients. Histological analysis of the captured debris was performed at Erasmus Medical Center as well as independently confirmed at the Cardiovascular Pathology Institute. The debris consisted of thrombotic, calcific and connective tissue. Overall, thrombotic material was found in 52% of patients and tissue fragments compatible with aortic valve or aortic wall origin in 52% of patients. The captured material varied in size from 0.15mm to 4.0mm.
Differential analysis provided further insight into the origin of captured aortic debris. The samples captured were compared with histological samples of surgically removed valve leaflets. Dr. Virmani noted "valve tissue consistent with aortic leaflets were captured in the filters in 27% of the patients with captured debris and either aortic valve or thrombotic material was captured in 75% of all patients undergoing TAVR. Therefore, it is important that we provide protection to patients undergoing TAVR."