Claret Medical, Inc. Announces Publication of the First Clinical Research on the Frequency and Composition of Embolic Debris Captured During TAVR
Published: May 20, 2013
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."
Speaking about the findings, Dr. Van Mieghem noted, "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. One may wonder, how long until embolic protection is used in every TAVI procedure?"
While Edwards and Medtronic continue to grow the multi-billion dollar TAVR market, Claret endeavors to improve patient outcomes by protecting the patient's cerebral vasculature with their proprietary dual-filter embolic protection system, the Montage 2. The Montage 2 Dual Filter System is CE-Marked, but not available for sale in the US.
About Claret Medical
Claret Medical is a privately-held company focused on innovative solutions for cerebral protection during vascular. valvular interventions and surgery. Claret is currently directing developmental and clinical research resources toward addressing stroke during TAVR, a significant unmet clinical need.
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SOURCE Claret Medical, Inc.
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