Abbott's Investigational MitraClip(R) System Demonstrates Strong Safety Results and Improved Clinical Outcomes for Common Causes of Leaky Heart Valves

By Abbott, PRNE
Monday, May 24, 2010

Preliminary Results Also Show MitraClip Device Maintains Durability through Two Years in Patients Treated for Mitral Regurgitation

PARIS, May 25, 2010 - 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(R) 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 MitraClip
system 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 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.

Media, Jonathon Hamilton, +1-408-624-0314, or Jennie Kim, +1-408-332-4176, or Financial, Larry Peepo, +1-847-935-6722, or Tina Ventura, +1-847-935-9390

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