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Sentara is Now Enrolling Patients in National Research Study to Test Dissolving Heart Device 

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VA Center investigates “dissolving” heart device designed to open heart vessel blockages

Norfolk, Virginia  (May 13, 2013) Sentara Cardiovascular Research Institute is now enrolling heart patients in a randomized multi-center clinical research trial to study an investigational “dissolving” device to treat blockages in the vessels serving the heart. The narrowing of vessels in the heart due to a buildup of plaque is known as coronary artery disease and is the leading cause of death in men and women in the U.S.

The study device, Absorb ™ is made by healthcare company Abbott and is designed to open blocked heart vessels and restore blood flow to the heart. Instead of permanent metallic stents used for decades, Absorb dissolves into the blood vessel over time. Absorb is made of a naturally dissolvable material commonly used in dissolving sutures. After Absorb dissolves, only two tiny pairs of markers remain in the artery and enable a physician to see where the device was placed.

“This innovative new device represents the next generation technology for the treatment of coronary artery disease. We’re excited to be part of research that could provide our patients with new treatment options in the future,” says Paul Mahoney, M.D., principal investigator for this study at Sentara.

Cardiologists practicing at Sentara Heart Hospital have opened the ABSORB III study to patients to test the safety and effectiveness of this new device compared with current standard treatment of medicated metallic heart stents called drug eluting stents.

Sentara plans to enroll up to 200 patients in the study who have coronary artery disease. They will be randomized to either receive the study device or have the standard treatment called a drug eluting stent.

Approximately 2,250 patients, mostly in the U.S., will be enrolled in the study. The results of the two groups will be compared.

About Coronary Artery Disease
Coronary artery disease is the narrowing of one or more arteries that supply blood to the heart. Symptoms of coronary artery disease include chest pain and shortness of breath when the demand for blood to the heart is more than the ability to supply it.

Each year, about 785,000 Americans have a first heart attack. Another 470,000 who have already experienced one or more heart attacks will have another. Heart disease accounts for one of every six deaths that take place in the U.S. 1

About Sentara Cardiovascular Research Institute
Sentara Cardiovascular Research Institute is part of Sentara Healthcare, one of the nation’s leading not-for-profit health systems and an acknowledged leader in patient safety and quality innovation. The Sentara Cardiovascular Research Institute grew out of a long history of providing exceptional heart care at Sentara. Established in 2005, Sentara Cardiovascular and Research Institute is now among the top cardiac research programs in the country, with about 70 ongoing studies per year.

About ABSORB III
The ABSORB III is a randomized pivotal trial sponsored by global healthcare company Abbott. The study, testing the safety and efficacy of a drug eluting, bioresorbable vascular scaffold (BVS), will enroll approximately 2,250 patients with the majority being in the United States.  Participants are at least 18 years old and have some blockages to vessels serving the heart. For more information about the study and eligibility, visit www.clinicaltrials.gov. The study identifier is NCT00856856.

Related Links:
Sentara Cardiovascular Research Institute
Sentara Heart Hospital
Clinical Trials

1 Signs and Symptoms, Centers for Disease Control and Prevention. April 9, 2012. http://www.cdc.gov/heartdisease/signs_symptoms.htm

 

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