Press Release
Abbott's Investigational MitraClip® System Demonstrates Strong Safety Results and Improved Clinical Outcomes for Common Causes of Leaky Heart Valves
- Preliminary Results Also Show MitraClip Device Maintains Durability through
Two Years in Patients Treated for Mitral Regurgitation
May 25, 2010
Paris — Abbott (NYSE: ABT)
today announced new data from the landmark EVEREST II (Endovascular Valve
Edge-to-Edge REpair STudy) trial, which provide additional details about the
safety and clinical benefit of Abbott's investigational MitraClip® system for
the two causes of mitral regurgitation (MR) – functional MR (FMR) or
degenerative MR (DMR). In the EVEREST II trial,
the 30-day major adverse event rate in the MitraClip arm was similar for the
FMR and DMR patient subgroups (8.2 percent for
FMR patients, 8.1 percent for DMR patients), both
lower than the surgical control group (42.6
percent). The MitraClip system also demonstrated consistent results in
both FMR and DMR patients with both subgroups showing significant improvement
at one year from baseline measures of heart function, symptoms and quality of
life. These results were presented today during the Late Breaking Registries
and Clinical Trial Updates session at the EuroPCR 2010 conference, and build
upon the positive EVEREST II primary endpoint
results that were presented during the American College of Cardiology 2010
meeting in March.
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 into the left atrium of the heart during the cardiac cycle. When
patients are diagnosed with MR, they are usually classified as having
functional MR or degenerative MR. Functional MR accounts for the majority of MR
patients, and occurs due to heart muscle abnormalities caused by coronary
artery disease or cardiomyopathy (a condition which causes the heart muscle to
weaken). Degenerative MR is caused by deterioration of valve tissue.
Additionally, Abbott presented results on a subset of patients within the
EVEREST II trial who had progressed to two years post procedure, which showed
that the positive clinical results achieved at one year with the
MitraClipsystem are sustained at two years in patients with significant MR. The
preliminary two-year results evaluated 86 of the 217 patients who had
successful MR reduction after treatment with a MitraClip device or open heart
surgery, and showed there was no difference in the need for subsequent mitral
valve surgery through two years between these two groups.
"The patient subgroup analysis shows that the catheter-based clip device
delivers consistent results regardless of FMR or DMR etiology. These results
are important because they are consistent with the results achieved in the
EVEREST High Risk Registry Study, indicating the device may be an option for
treatment for a range of patients with MR," 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. "In addition, the data on the
durability of the clip device compared to surgery through two years adds to my
confidence that a treatment strategy with the clip may be a viable choice for
certain patients who are looking for other options to treat their leaky heart
valve."
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). 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.
"Continued advancements in medical device technology are bringing more
options and tremendous benefits to patient care. The MitraClip device is a
novel treatment, and these preliminary data indicate the device has sustained
mid-term benefits and can be an option for some patients with FMR or DMR,"
said Charles A. Simonton, M.D., FACC, FSCAI, divisional vice president, Medical
Affairs, and chief medical officer, Abbott Vascular.
The MitraClip system received CE Mark in March 2008. In the United States,
the MitraClip device is limited by federal law to investigational use only and
is not available for sale. The MitraClip system is currently under review for
approval by the U.S. Food and Drug Administration.
More About the EVEREST II Patient Subgroup Analysis
The EVEREST II trial is the first randomized trial of any minimally invasive
mitral valve repair device compared to mitral valve surgery. 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. 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.
The patient subgroup analysis included 135 patients with DMR and 49 patients
with FMR. At one year, the MitraClip procedure demonstrated the following
results in FMR and DMR patients:
- An improvement in heart function as indicated by a reduction in both left
ventricular end diastolic volume (LVEDV) and left ventricular end systolic
volume (LVESV). In FMR patients, LVEDV decreased 10.6
percent and LVESV decreased 7.7 percent
compared to baseline. Similarly, in DMR patients, LVEDV decreased 15 percent and LVESV decreased 6.7 percent compared to baseline.
- An improvement in symptoms, with 96.7 percent of FMR patients and 97.8
percent of DMR patients exhibiting no symptoms (NYHA Functional Class I) or mild symptoms (NYHA Functional Class II), whereas at baseline, 64.5 percent of FMR patients and 45.2 percent of DMR 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 1.6 points
for FMR patients and 5.6 points for DMR patients in the physical quality of
life score, and increase of 8.7 points for FMR patients and 5.0 points for DMR
patients in the mental quality of life score).
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 United States and Europe. There are more than 600,000 new
diagnoses of significant MR each year in the United States 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.
Media:
Jonathon Hamilton
Jennie Kim |
(408) 624-0314
(408) 332-4176 |
Financial Community:
Larry Peepo
Tina Ventura |
(847) 935-6722
(847) 935-9390 |
