Analysis Published of Embolic Debris Captured During TAVR Using Claret Medical's Montage 2 System

May 20, 2013—Claret Medical, Inc. (Santa Rosa, CA) announced that Nicolas M. Van Mieghem, MD, et al published a study on the histopathology of embolic debris captured during transcatheter aortic valve replacement (TAVR) using the company's Montage 2 dual-filter embolic protection system. The study is available online ahead of print in Circulation.

The company noted that this investigation was a collaboration between Erasmus Medical Center in Rotterdam, The Netherlands, and a pathology team from the Cardiovascular Pathology (CVPath) Institute in Gaithersburg, Maryland, led by Renu Vermani, MD. Dr. Vermani is President and Medical Director of the CVPath Institute.

According to Claret Medical, this is the first investigation to report the frequency and composition of debris captured in a series of patients who underwent TAVR combined with the use of the Claret Montage 2 dual-filter system. The investigators found visible debris in 75% of the 40 patients in the study. Histological analysis of the captured debris was performed at Erasmus Medical Center and independently confirmed at the CVPath Institute. The debris consisted of thrombotic, calcific, and connective tissue.

Overall, thrombotic material was found in 52% of patients. Tissue fragments compatible with aortic valve or aortic wall origin were found in 52% of patients. The captured material varied in size from 0.15 mm to 4 mm. 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.

In Claret's press release, Dr. Virmani commented, "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.”

Dr. Van Mieghem added, “During almost every TAVR 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 TAVR procedure?”

The Montage 2 dual-filter system has received CE Mark approval, but it is not available for sale in the United States, advised Claret Medical.