Guided Delivery Systems, Inc. Successfully Treats First Patient with Mitral Regurgitation

Santa Clara, California (ots/PRNewswire) -

Guided Delivery Systems, Inc. ("GDS") announced the first
successful percutaneous implantation of the GDS Accucinch(R) System
for mitral valve repair. The procedure was performed by Prof. Dr.
med. Joachim Schofer of Medizinisches Versorgungszentrum, Hamburg
University Cardiovascular Center in Hamburg, Germany. The GDS
Accucinch System significantly reduced the patient's mitral
regurgitation without requiring open heart surgery.

Dr. Schofer commented, "While mitral valve repair is a common
surgical procedure, it usually requires open heart surgery. The GDS
Accucinch System is introduced using catheters placed through the
femoral artery. The interventional cardiologist can mimic a surgical
mitral valve repair without opening the chest and without the need
for heart lung bypass. Using this new technology the patient can be
treated in a safe, less invasive way so he or she can quickly resume
normal day-to-day activities. In fact, this particular patient was up
and walking the day after the procedure, and able to return home to
normal activities within a week."

Mitral valve regurgitation, or leakage, is a significant cardiac
problem in approximately six million patients worldwide(1). Leakage
is often caused by enlargement of the mitral ring, or annulus,
preventing the mitral leaflets from closing effectively. The GDS
Accucinch System is an innovative percutaneous device, placed through
an artery in the patient's leg that cinches the subvalvular mitral
annulus to reduce its size until the backward flow of blood through
the mitral valve is corrected. This device mimics surgical mitral
repair by directly modifying the geometry of the mitral apparatus in
order to reduce mitral regurgitation. The GDS Accucinch System can
also properly size the mitral opening by use of measurements of
regurgitation in the beating heart during the procedure which cannot
be made when the patient is on a bypass machine.

"Our goal at GDS is to develop a fully percutaneous treatment of
the mitral valve and left ventricle to correct functional mitral
regurgitation that leverages standard imaging and physician skills,"
said inventor of the GDS Accucinch System and CEO of Guided Delivery
Systems, Niel Starksen, M.D. "First human use of the percutaneous
delivery of the GDS Accucinch System is an important milestone on the
pathway to bringing the millions of patients with functional mitral
regurgitation a safe and effective treatment using the skills that
interventional cardiologists already have and practice every day."

Dr. Schofer will discuss the GDS Accucinch System and highlights
from the case further on September 25, 2009 during the 2009
Transcatheter Cardiovascular Therapeutics (TCT) Conference being held
in San Francisco, CA.

Dr. John Webb, St. Paul's Hospital, University of British
Columbia, Vancouver, Canada is Co-Principal Investigator for the
clinical trial and is actively screening patients for the study. The
number of clinical sites is expanding to include additional sites in
both Germany and Canada, and additional studies are being planned in
the United States.

About Mitral Valve Regurgitation

Mitral valve regurgitation or MR is a condition in which the
mitral valve, one of the valves in the heart, does not close tightly
during the cardiac cycle, allowing the blood to flow backward. Since
the blood is not moving as efficiently as it should through the heart
and the body, MR can result in fatigue and shortness of breath. As
many as one in five people over the age of 55 may have some level of
MR(2). It has been estimated that more than one in eight people aged
greater than 75 years old have at least moderate heart valve
disease(3) a population expected to quadruple in the next 50
years(4). Furthermore, many patients with heart failure are found to
have moderate to severe MR. MR is, therefore, a common and serious
condition that may be addressed by new technologies, like the GDS
Accucinch System, in the future.

About Guided Delivery Systems, Inc.

Guided Delivery Systems, Inc. is a privately funded,
development-stage company founded in December 2002, based in Santa
Clara, California. The company's mission is to become the industry
leader in providing safe, minimally invasive and clinically effective
solutions to millions of untreated patients with life impairing and
potentially life threatening heart valve conditions. For more
information, please contact Peggy Arvizu at +1-408-727-1105 ext. 204.

The GDS Accucinch System is not currently available in the U.S.A.
for sale or clinical trials. Clinical evaluation is in process in
Europe and Canada.

1. Health Research International, "Opportunities in Heart Valve
Disease Management: Europe, Japan and Rest of the World", pages 93
and 96; and "U.S. Opportunities in Heart Valve Disease Management",
page 74.

2.
http://www.mayoclinic.com/health/mitral-valve-regurgitation/DS00421

3.
http://www.nhlbi.nih.gov/health/dci/Diseases/hvd/hvd_whoisatrisk.html

4.
http://www.mayoclinic.com/health/mitral-valve-regurgitation/DS00421/
DSECTION=symptoms

ots Originaltext: Guided Delivery Systems, Inc.
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Peggy Arvizu of Guided Delivery Systems, Inc., +1-408-727-1105, ext.
204