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| MitraClip cardiac device--Courtesy of Abbott |
A study presented at the annual Heart Rhythm Society meeting in Boston found that Abbott's ($ABT) percutaneous MitraClip mitral valve repair device cut the number of ventricular tachyarrhythmia (VT) episodes in half following implantation in patients who had a prior cardiac rhythm device like a pacemaker or implantable cardioverter defibrillator.
The researchers studied 50 patients before and after implantation of the MitraClip over 20 months. There were 68 sustained VT episodes in the patient prior to implantation, and 30 after. The number of long-lasting episodes (those with a cycle length of more than 300 milliseconds) recorded was 46 prior to implantation and 21 episodes following use of the MitraClip.
The number of non-significant VT episodes fell from 56 to 49 after implantation, a statistically insignificant difference.
"We can show that the MitraClip therapy results in a significant reduction in ventricular arrhythmia burden, especially in ICD patients," said Dr. Cathrin Theis during the May 14 presentation, according to MassDevice.
Studies demonstrating efficacy of the MitraClip are crucial because the device got FDA's approval in 2013 despite the results from its pivotal trial, which found that MitraClip posted almost no clinical benefits over traditional valve surgery after four years.
On top of this study comparing the device to ICDs, experts at the annual meeting of the American College of Cardiology said post market registry data collected on the MitraClip shows that the device is safe and effective, for the primary clinical benefit of a reduction in mitral regurgitation was achieved in 63.7% of patients.
The MitraClip is meant to treat mitral regurgitation, which is associated with ventricular tachyarrhythmia. Mitral regurgitation involves a leaky heart valve that lets blood flow backward and can cause irregular heartbeats, stroke or heart failure. MitraClip is delivered via catheter through the femoral vein in the leg, and it clips together parts of the mitral valve. The solution is meant to be less invasive than regular surgery.
"The market opportunity for mitral regurgitation is significant but still in its early stages, and MitraClip is the only product on the market to-date that can treat this disease in a minimally invasive way," said Abbott CEO Miles White during its most recent earnings call.
He said sales of the device increased at a double-digit rate in both the U.S. and abroad.
- read the study
- here's MassDevice's take