New Data Demonstrates Abbott's Investigational MitraClip(R) System Has Potential to be a Valuable Treatment Option for Patients With Mitral Regurgitation, the Most Common Heart Valve Condition
By Abbott, PRNESaturday, March 13, 2010
First-of-its-Kind, Catheter-Based Device for Mitral Valve Repair Meets Both Primary Safety and Effectiveness Endpoints Compared to Surgery
ATLANTA, March 14, 2010 - Late-breaking data presented today at the American College of
Cardiology's 59th annual scientific session from the landmark EVEREST II
(Endovascular Valve Edge-to-Edge REpair STudy) trial demonstrated that
Abbott's investigational MitraClip(R) system met both its primary safety and
effectiveness endpoints(1), suggesting that the minimally invasive MitraClip
procedure may be an important treatment option for patients with significant
mitral regurgitation (MR). At one year, the MitraClip device demonstrated
meaningful clinical benefits for patients with significant MR, including
improvements in heart function, quality of life, and normal physical
activity, and a decrease in cardiac symptoms. The EVEREST II trial is the
first randomized trial of any minimally invasive mitral valve repair device
compared to mitral valve surgery.
The MitraClip system includes a catheter-based device, which is delivered
to the heart through a blood vessel in the leg (femoral vein). The MitraClip
device is designed to reduce significant MR by clipping together the leaflets
of the mitral valve (one of the four valves of the heart). MR is the most
common type of heart valve insufficiency and occurs when the leaflets of the
mitral valve do not close completely, causing blood to flow backwards and
leak into the left atrium of the heart during the cardiac cycle. To maintain
an adequate forward flow of blood throughout the body, the heart compensates
by increasing the size of the left ventricle (main pumping chamber of the
heart) to accommodate the increase in the volume of blood it is pumping.
Mitral regurgitation affects more than 8 million people in the United
States and Europe and is currently managed with drugs or open heart surgery,
depending on an individual patient's severity of MR and risk factors.
Significant MR is a debilitating condition where the heart's ability to
function continues to deteriorate over time, and may lead to irregular
heartbeat, heart failure, stroke, heart attack or death.
"In the EVEREST II trial, the catheter-based system exhibited a highly
favorable safety profile, while providing meaningful and sustained clinical
benefits," said 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, IL; and
co-principal investigator of the EVEREST II trial. "The positive trial
results validate my experience that the procedure is a valuable therapeutic
option for select patients with mitral regurgitation. The therapy has the
potential to transform the lives of thousands of patients, and enable some to
go from bed rest to a more active lifestyle."
In the EVEREST II trial's primary safety endpoint of major adverse events
(MAEs) at 30 days, the MitraClip system demonstrated a superior safety
profile (p<0.0001) compared to surgical repair or replacement (9.6 percent of
MitraClip patients and 57.0 percent of surgery patients had an MAE). Major
adverse events is defined as a composite of 12 pre-specified adverse events.
In the primary effectiveness endpoint, the MitraClip device was non-inferior
to surgery at one year (clinical success rate of 72.4 percent for MitraClip
patients with successful initial treatment compared to a clinical success
rate of 87.8 percent for surgery patients). With 95 percent confidence, the
clinical success rate of the MitraClip device falls within 25.4 percent of
the clinical success rate of the surgical control. In the primary
effectiveness endpoint, the clinical success rate is defined as freedom from
death, surgery for valve dysfunction and moderate to severe MR (greater than
2+) at one year in patients with successful initial treatment.
At one year, the MitraClip procedure demonstrated meaningful clinical
benefits in the following secondary endpoints in patients with successful
initial treatment:
- A reduction in the severity of MR, with 81.5 percent of patients improving to mild (grade 1+) or moderate (grade 2+) MR whereas at baseline 95.6 percent of patients had moderate-to-severe (grade 3+) or severe (grade 4+) MR (p<0.0001). - A reduction in both the volume (left ventricular diastolic volumes) and the diameter of the left ventricle heart chamber (left ventricular diastolic dimensions), indicating an improvement in heart function. Left ventricular diastolic volumes decreased a significant 13 percent (p<0.0001) and left ventricular diastolic dimensions decreased a significant 6.4 percent (p<0.0001) compared to baseline. - An improvement in symptoms, with 97.5 percent of patients exhibiting no symptoms (NYHA Functional Class I) or mild symptoms (NYHA Functional Class II) [p<0.0001], whereas at baseline, 52.6 percent of patients had moderate symptoms (NYHA Functional Class III) or severe symptoms (NYHA Functional Class IV). Patients who are classified as NYHA Functional Class III or IV experience marked or severe limitations in physical activity. - Meaningful improvements in both physical and mental quality of life compared to baseline as measured by the SF-36 Survey (increase of 4.7 points in the physical quality of life score [p<0.0001] and increase of 5.8 points in the mental quality of life score [p<0.0001]).
"The EVEREST II safety and effectiveness results support the MitraClip
device as a treatment choice, and show that MitraClip patients still have the
option for successful mitral valve surgery afterward if needed," said Donald
Glower, M.D., professor of surgery, Cardiovascular and Thoracic Surgery
Division, Duke University School of Medicine, Durham, NC; and co-principal
investigator of the EVEREST II trial. "The improvements in symptoms, quality
of life and cardiac function shown in the EVEREST II trial suggest the
MitraClip procedure may be another valuable treatment option for certain
patients with significant MR."
"When treating patients with significant MR, clinicians need to consider
the benefits of the available treatment options and an individual patient's
risk factors to determine the best course of therapy," said Charles A.
Simonton, M.D., FACC, FSCAI, divisional vice president, Medical Affairs, and
chief medical officer, Abbott Vascular. "Based on the positive risk-benefit
profile demonstrated in the EVEREST II randomized trial and other EVEREST
trials, the MitraClip procedure has the potential to be an important addition
to the current options for treating certain patients with significant MR."
The MitraClip system received CE Mark in March 2008. The MitraClip device
is an investigational device in the United States, and is currently under
review for approval by the U.S. Food and Drug Administration (FDA).
About the EVEREST II Trial
The EVEREST II pivotal trial is a multi-center, randomized clinical trial
of 279 patients with moderate-to-severe (3+) or severe (4+) mitral
regurgitation who were candidates for mitral valve surgery. The mean age for
patients was 68 years, and patients in the trial tended to have more
co-morbidities, such as hypertension and congestive heart failure, than the
average surgical patient as defined by the 2008 Society for Thoracic Surgeons
(STS) Database. Patients were selected for treatment with the MitraClip
device if they met the criteria for surgical intervention from the 1998/2006
American College of Cardiology (ACC)/ American Heart Association (AHA) Joint
Task Force Recommendations regarding therapy for valvular heart disease.
Patients had at least moderate-to-severe functional or degenerative mitral
regurgitation and were either symptomatic or asymptomatic with evidence of
compromised left ventricular function, atrial fibrillation or pulmonary
hypertension. The echocardiography core laboratory at the University of
California, San Francisco (UCSF) reviewed the trial's echocardiograms based
on the American Society of Echocardiography (ASE) criteria for assessment of
MR and left ventricular function.
About Mitral Regurgitation
MR is the most common type of heart valve insufficiency in the United
States and Europe, affecting millions of people worldwide. MR affects more
than 8 million people in the U.S. and Europe. There are more than 600,000 new
diagnoses of significant MR each year in the U.S. and Europe; however, only
about 20 percent of these patients undergo surgery each year. While many
patients are either higher-risk surgical patients or not sick enough for
surgery, approximately 80 percent of patients with MR continue to be affected
by the chronic volume overload caused by MR, which requires the heart to work
harder, and may ultimately lead to heart failure and other complications.
About the MitraClip Technology and Procedure
Abbott's proprietary MitraClip system is used for catheter-based mitral
valve repair in patients suffering from the effects of mitral regurgitation.
Mitral valve repair with the MitraClip system is performed by physicians in
the catheterization laboratory. The heart beats normally during the
procedure, and therefore does not require a heart-lung bypass machine. After
treatment, patients have been observed to recover quickly. The MitraClip
system is intended to provide another treatment option in the existing
continuum of care, including medical management and open, arrested heart
surgical options. The MitraClip device may help MR patients avoid or delay
surgery.
About Abbott Vascular
Abbott Vascular is a global leader in cardiac and vascular care with
market-leading products and an industry-leading pipeline. Abbott Vascular
offers a comprehensive cardiac and vascular devices portfolio, including
products for coronary artery disease, vessel closure, endovascular disease,
and structural heart disease.
About Abbott
Abbott (NYSE: ABT) is a global, broad-based health care company devoted
to the discovery, development, manufacture and marketing of pharmaceuticals
and medical products, including nutritionals, devices and diagnostics. The
company employs approximately 83,000 people and markets its products in more
than 130 countries.
Abbott's news releases and other information are available on the
company's Web site at www.abbott.com/.
(1) In the EVEREST II trial, the primary safety endpoint is defined as
major adverse events at 30 days, and the primary effectiveness endpoint is
defined as freedom from death, surgery for valve dysfunction and moderate to
severe MR (greater than grade 2+) at one year in patients with successful
initial treatment.
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