New study demonstrates value of Mitra Clip in Cardiac Surgery-Abbott

In a new study - a transcatheter valve therapy (TVT) registry formed from a partnership with the Society of Thoracic Surgeons and American College of Cardiology - researchers evaluated data from 564 people with a transcatheter mitral valve repair (TMVR) who were treated with Mitra Clip, from Abbott, following FDA approval of the device in October 2013 through August 2014. The data continue to support the use of Mitra Clip, with successful treatment for 93 percent of people in the study.

The treated group's median age was 83 years-old, and they were not candidates for surgery because they were too frail or had other complicating factors. Results suggest that treatment with Mitra Clip for prohibitive risk patients with symptomatic mitral regurgitation (MR) is durable in a real-world commercial setting. Key findings demonstrated the following: Prior to treatment, more than 90 percent of patients had a mitral regurgitation grade of 3 or 4, indicating significant leakage of the mitral valve. After treatment with Mitra Clip, 93 percent of patients achieved an MR grade of less than or equal to 2, with 63.6 percent at a grade of less than or equal to 1, demonstrating a significant decrease in leakage. Average length of stay in the hospital was 3 days, with 82 percent discharged home. Finally, adverse events and procedural complications were low, consistent with clinical trial experience.

Dr. Sorajja, the lead investigator for this study, shared the data at the American College of Cardiology session.

Comment: Abbott Vascular acquired the rights to Mitra Clip when it acquired Evalve Inc. Use of the device may cut hospitalization time by half, and shorten recovery by at least six weeks. Until recently, Mitra Clip had been the sole TMVR device approved in Europe but Cardiac Dimensions and NeoChord have now gained CE marking for their TMVR devices. More than 25 companies are currently developing transcatheter aortic valve replacement, or transcatheter mitral valve repair or replacement devices.