FDA Advisory Committee Votes Favorably on Abbott Vascular's MitraClip

March 20, 2013—Abbott Vascular (Santa Clara, CA) announced that the US 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 company’s 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 comorbidities would not preclude the expected benefit from correction of the MR. The MitraClip device received CE Mark approval in 2008 and is commercially available in Europe and other international markets. It is an investigational device in the United States.

According to Abbott Vascular, the 8-member panel voted unanimously “yes” on the question of whether there is reasonable assurance the device is safe. On the question of whether there is reasonable assurance of efficacy, the panel voted Yes: 4, No: 5, with Chair Jeffrey Borer, MD, of the State University of New York, casting the tie-breaking vote. 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 company noted that 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 life, and reduced rates of rehospitalization.

On March 10, Abbott Vascular announced that data from the EVEREST II (Endovascular Valve Edge-to-Edge Repair Study) High Surgical Risk cohort evaluating the MitraClip System for the treatment of MR were presented at the 62nd annual scientific session of the American College of Cardiology in San Francisco, California.

According to Abbott Vascular, the EVEREST II High Surgical Risk cohort included data from patients enrolled in the multicenter EVEREST II High Risk and REALISM continued-access studies.

As summarized in the company’s announcement, findings from 351 symptomatic patients in the United States who were deemed too high risk for open mitral valve surgery demonstrated a 30-day mortality rate significantly lower than expected for surgery (4.8% for patients treated with the MitraClip system vs 18.2% predicted surgical mortality; P < .0001); a low rate of adverse events, despite the high surgical risk profile of the patients; an implant success rate of 96%; acute reduction in MR to 2+ or less achieved in 86% of patients treated with the MitraClip device; clinically significant improvement in left ventricular size, significant improvements in NYHA Functional Class and SF-36 Quality of Life scores; and significantly reduced rates of hospitalization for heart failure (48% reduction from 1 year postdischarge compared to the year before treatment, P < .0001).

“Patients with MR who are not candidates for mitral valve surgery due to risk of mortality have an unmet need for a treatment option that will reduce symptoms and improve the quality of their lives,” commented D. Scott Lim, MD, in the company’s announcement. Dr. Lim is associate professor of cardiovascular medicine at the University of Virginia Health System in Charlottesville, Virginia. He added, “The findings of the EVEREST II High Surgical Risk cohort suggest that treatment with the MitraClip device represents a new option that could allow these high-risk patients to return to activities they enjoy, and results in a reduction in hospitalizations for heart failure.”