Abbott Laboratories (NYSE:ABT) recently presented successful trial data for its minimally invasive devices, TriClip and MitraClip G4, at the 35th TCT annual scientific symposium. The devices are used to treat severe tricuspid regurgitation (TR) and mitral regurgitation (MR), conditions that lead to backward blood flow in the heart.
The TRILUMINATE trial was conducted to evaluate the safety and effectiveness of the TriClip device. The trial included 572 randomized patients, with results emphasizing the device's role in improving patient quality of life, according to Michael Dale, SVP of Abbott’s structural heart business.
Meanwhile, the MitraClip EXPAND G4 registry assessed the performance of the MitraClip G4 device in over 1,100 patients across a broad range of anatomies. The study observed the highest MR reduction in a mitral TEER study to date, with 93% of patients achieving MR reduction to mild or less.
In addition to these devices, Abbott's Tendyne TMVR system has also demonstrated encouraging early results in treating severe MR and mitral annular calcification (MAC), as per data from the SUMMIT program. A roll-in cohort of 100 patients showed a one-year survival rate of 74.3%, with incidences of disabling stroke, myocardial infarction, and postoperative mitral reintervention at 5.4%, 2.3%, and 2.2% respectively.
Another cohort of 103 individuals with severe MAC treated with Tendyne TMVR reported positive outcomes after 30 days. The rates for all-cause mortality, disabling stroke, myocardial infarction, and postoperative mitral reintervention were at 6.8%, 1.0%, 1.0%, and 2.0% respectively. The Tendyne device, a tri-leaflet bioprosthetic valve attached to an apical pad over the ventricular access site, is implanted surgically through a thoracotomy procedure in a transapical approach.
Despite a high screening failure rate with only 103 out of 474 patients meeting the criteria for Tendyne, primarily due to insufficient neo-left ventricular outflow tract (neoLVOT) and annular dimensions being too small or large, the roll-in cohort achieved a procedural survival rate of 100% and technical success of 94%. Notably, baseline MR severity saw significant improvement at both one month and one year post-procedure.
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