Home Heart Failure Symptoms Ancora Heart Expands Enrollment of US Early Feasibility Study for the AccuCinch System for Left Ventricular Repair

Ancora Heart Expands Enrollment of US Early Feasibility Study for the AccuCinch System for Left Ventricular Repair

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SANTA CLARA, Calif.--(Business Wire)--Ancora Heart, Inc., a company developing a novel therapy to address
heart failure, today announced the expansion of the company’s U.S.
feasibility study to evaluate the investigational AccuCinch®
Ventricular Repair System designed for the treatment of heart failure
and functional mitral regurgitation (FMR).

Ancora has received approval from the U.S. Food and Drug Administration
(FDA) to enroll a second group of subjects and expand to 15 heart
centers across the United States.

“We are pleased that the FDA has approved expansion of this study, as it
will allow us to continue to gather valuable clinical information about
AccuCinch,” said Jeff Closs, president and CEO of Ancora Heart. “We are
encouraged by our early clinical experience and interest from new heart
centers to participate in the study.”

The AccuCinch procedure is intended to directly repair the enlarged left
ventricle, targeting the underlying cause of heart failure. This
minimally invasive procedure is designed to reduce the size of the left
ventricle, improve left ventricular function, and reduce symptoms of
heart failure, with the goal of improving quality of life for patients.

“Today there is an enormous unmet need for effective treatment options
for patients with heart failure, as many patients either do not undergo
or may not benefit from traditional surgical approaches,” said Paul
Sorajja, M.D., Roger L. and Lynn C. Headrick Family Chair for Valve
Science Research at the Minneapolis Heart Institute Foundation®
Valve Science Center, and principal investigator for the study at
Minneapolis Heart. “Early results suggest that AccuCinch has the
potential to be the first therapy of its kind to treat dysfunction of
the left ventricle and indicate this approach may address the
shortcomings of current heart failure and FMR treatments.”

The AccuCinch therapy has the potential to treat heart failure and FMR
patients in whom the disease has progressed beyond the ability for
medications and pacemakers to manage symptoms or for whom the risks of
open-heart surgery are too high. Unlike current technologies that
replicate surgical procedures to replace or repair an otherwise-normal
mitral valve, AccuCinch is designed to repair the left ventricle
directly to enable proper mitral valve function.

About Heart Failure and Functional Mitral Regurgitation

About 6.5 million U.S. adults live with heart failure, a condition in
which the heart’s muscles slowly weaken and lose their ability to pump
enough oxygen-rich blood to the body.1 Up to 74 percent of
people with heart failure also suffer from FMR, a condition caused when
the left ventricle of the heart becomes enlarged to the point where it
pulls the mitral valve leaflets apart and allows blood to flow backwards
into the left atrium.2 Heart failure and FMR patients suffer
from debilitating symptoms including persistent exhaustion, trouble
breathing, confusion and loss of memory. There is no cure for heart
failure or FMR, and about half of people who develop heart failure die
within five years of diagnosis.1

About Ancora Heart

Ancora Heart, Inc., based in Santa Clara, Calif., is dedicated to
helping people with heart failure feel better and live longer. Ancora
Heart developed the AccuCinch System, an investigational therapy
designed to repair the enlarged left ventricle targeting the underlying
cause of heart failure. The AccuCinch heart failure treatment was
created to benefit the millions of patients who otherwise have no
minimally invasive option available to them. For more information visit www.ancoraheart.com.

1 Benjamin E.J., Blaha M.J., Chiuve S.E., et al. Heart
disease and stroke statistics—2017 update: a report from the American
Heart Association. Circulation 2017; 135: pp. e146-e603

2 Al-Amri, H. S., Al-Moghairi, A. M., & El Oakley, R. M.
(2011). Surgical treatment of functional mitral regurgitation in dilated
cardiomyopathy. Journal of the Saudi Heart Association, 23(3), 125–134. http://doi.org/10.1016/j.jsha.2011.04.001

View source version on businesswire.com: https://www.businesswire.com/news/home/20180514005417/en/

Ancora Heart:
Bart Beasley, 408-727-1105
[email protected]
Contact for Ancora Heart:
Sierra Smith, 408-540-4296
[email protected]

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