Feature | March 22, 2013

FDA Advisory Committee Supports MitraClip for Patients With Significant Mitral Regurgitation Who Are Too High Risk for Surgery

Abbot MitraClip

March 22, 2013 —  Abbott announced that the U.S. Food and Drug Administration (FDA) Circulatory System Devices Panel of the Medical Devices Advisory Committee has voted by majority (Yes: 5, No: 3) that the benefits of treatment with the MitraClip device outweigh its risks in patients with significant symptomatic mitral regurgitation (MR) who have been determined by a cardiac surgeon to be too high risk for open mitral valve surgery and in whom existing co-morbidities would not preclude the expected benefit from correction of the MR.

Abbott's MitraClip device, which received CE mark in 2008 and is commercially available in Europe and other international markets, is an investigational device in the United States. The device is delivered to the heart through the femoral vein, a blood vessel in the leg, and is designed to reduce MR by clipping together a portion of the leaflets of the mitral valve to allow the heart to more efficiently pump blood.   

"We appreciate the FDA's dedication of time and resources to convene this advisory panel for MitraClip and for its review of this new and novel technology for high surgical risk patients suffering from the debilitating symptoms of significant mitral regurgitation," said Charles A. Simonton, M.D., FACC, FSCAI, divisional vice president, Medical Affairs, and chief medical officer, Abbott Vascular. "

On the separate question of whether there is reasonable assurance the device is safe, the panel voted Yes: 8, No: 0. On the question of whether there is reasonable assurance of efficacy, the panel voted Yes: 4, No: 5. The FDA will take into account the panel's advice in making its decision on whether to approve the MitraClip for the treatment of significant MR in the United States. The company expects a decision later this year.

The committee's recommendation followed a review of data from a large and growing body of clinical evidence (EVEREST II, EVEREST II High Risk and REALISM) in which the MitraClip therapy demonstrated positive and consistent results for high surgical risk patients suffering from the debilitating symptoms of significant MR, including a safe procedure, reduction in MR, reverse left ventricular remodeling, improvement in heart failure symptoms, improvements in quality of lifeand reduced rates of re-hospitalization.

For more information: www.abbott.com

Reference:

1. Nkomo VT, Gardin JM, Skelton TN, Gottdiener JS, Scott CG, Enriquez-Sarano M. “Burden of valvular heart diseases: a population-based study.” Lancet. 2006 Sept. 16; 368(9540):1005-11.

Related Content

CMS Finalizes Updates to Coverage Policy for Transcatheter Aortic Valve Replacement
Feature | Heart Valve Technology | June 24, 2019
The Centers for Medicare and Medicaid Services (CMS) recently finalized its decision to update the national coverage...
Abbott Tricuspid Valve Repair System Reduces Tricuspid Regurgitation at 30 Days
News | Heart Valve Technology | June 11, 2019
June 11, 2019 — Abbott recently announced positive late-breaking data from its TRILUMINATE...
DSM and SAT Partnering to Develop Next-Generation, Cost-Effective Heart Valve
News | Heart Valve Technology | June 04, 2019
Royal DSM recently announced a collaboration with Strait Access Technologies (SAT), to develop the world’s first...

The MitraClip is one example of a transcatheter mitral valve repair or replacement (TMVR) device used in the structural heart repair program at Henry Ford Hospital.

Podcast | Heart Valve Technology | May 31, 2019
Marvin Eng, M.D., structural fellowship director at Henry Ford Health System, and William O'Neill, M.D., director of
Illustration showing the catheter steps for the LAMPOON procedure designed to prevent left ventricular outflow tract (LVOT) obstruction . From Dr. Jaffar M. Khan and the Laboratory of Cardiovascular Intervention, led by Dr. Robert J. Lederman.

Figure 1: Illustration showing the catheter steps for the LAMPOON procedure. From Dr. Jaffar M. Khan and the Laboratory of Cardiovascular Intervention, led by Dr. Robert J. Lederman.

Feature | Heart Valve Technology | May 22, 2019
Researchers at the National, Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH
Edwards Announces Research Milestones for Pascal Transcatheter Mitral Valve Program
News | Heart Valve Technology | May 22, 2019
Edwards Lifesciences Corp. announced strategic clinical and regulatory milestones for its Edwards Pascal transcatheter...
Videos | Heart Valve Technology | May 20, 2019
A demonstration of how to calculate the neo-left ventricular outflow tract (neo-LVOT) on CT imaging for a transcathet
Study Finds TAVR Can Be Considered for Patients in All Surgical Risk Classes
News | Heart Valve Technology | May 08, 2019
Transcatheter aortic valve replacement (TAVR) has been studied as an alternative to surgical aortic valve replacement...
Boston Scientific Receives FDA Approval for Lotus Edge Aortic Valve System
Feature | Heart Valve Technology | April 23, 2019 | Dave Fornell, Editor
Boston Scientific Corp. announced it has received U.S. Food and Drug Administration (FDA) approval for the Lotus Edge...
New Consensus Document Explores Optimized Care for Valvular Heart Disease Patients
News | Heart Valve Technology | April 22, 2019
April 22, 2019 — Five cardiovascular professional societies released a new consensus document on optimizing care for
Overlay Init