Last week we announced that Abbott had gained FDA approval for its Mitraclip® device. In a piece of beautifully orchestrated management the company trotted off to TCT2013, approval in hand. All they needed now was for a nice new clinical paper to be presented at the event. And so it came to pass with a new study that was simultaneously published in the Journal of the American College of Cardiology.
Background
The MitraClip device was originally developed by Evalve and CE marked in 2009 before the company’s acquisition by Abbott. Four years on FDA’s approval now means it’s available in the United States for patients with significant symptomatic degenerative MR who are at prohibitive risk for mitral valve surgery.
Multiple trials, published reports, and registries of patients treated with the MitraClip device consistently demonstrate a positive safety profile, reduction in mitral regurgitation, improvement in symptoms, and reduction in hospitalizations for heart failure, even in some of the most ill and debilitated patients.
So to the new US study, presented at TCT2013 by Ted Feldman, M.D., FSCAI, director, Cardiac Catheterization Laboratory and The Mr. and Mrs. Charles R. Walgreen Chair in Interventional Cardiology, NorthShore University HealthSystem, Evanston, Ill. The study included data from 127 patients treated with the device. Following MitraClip treatment, changes in quality-of-life measures were well above established thresholds showing minimum clinically important differences. A 73% reduction in rehospitalization for heart failure was accompanied by cardiac functional improvements, with 76 percent of patients with baseline NYHA Functional Class III improving to NYHA Functional Class I or II, and 65 percent of patients with baseline NYHA Functional Class IV improving to NYHA Functional Class I or II. And there’s more: Patients treated with Mitraclip showed favorable ventricular remodeling, with left ventricular end-diastolic and end-systolic volume decreased significantly at one year compared with baseline. 87% of patients were discharged to home rather than to nursing care.
Investigator comments
“The results of this study show that, even for some of the most ill and debilitated patients, the MitraClip system is safe and results in good clinical outcomes,” said D. Scott Lim, M.D., associate professor of Cardiovascular Medicine at the University of Virginia Health System in Charlottesville, Va., and lead author of the publication. “These prohibitive-risk patients have had, until now, no approved therapies to improve the quality of their lives.”
Company comments
“These positive results, which were reviewed as part of the totality of data from Abbott’s FDA submission, along with clinical results from more than 2,200 patients treated with the device, confirm the benefit of the innovative MitraClip therapy for this very sick patient population,” said Chuck Foltz, senior vice president, vascular, Abbott. “This year’s TCT conference has been particularly exciting for Abbott, with enormous enthusiasm about MitraClip from clinicians in the United States and around the world, and more than 65 presentations highlighting data related to the therapy.”
Source: Abbott, PR Newswire
published: October 31, 2013 in: Abbott, Approval/Clearance, Cardio, Clinical Studies/Trials, Congresses and Meetings