March 8, 2013
INDIANAPOLIS – St.Vincent Heart Center of Indiana is first in the state to participate in a clinical study for a bioresorbable heart stent. St.Vincent Heart Center of Indiana is participating in the landmark clinical trial to implant Absorb™, an investigational bioresorbable vascular scaffold (BVS), as part of the ABSORB III clinical trial. The trial recently started in the United States is manufactured by the healthcare company Abbott. Absorb is a small mesh tube that is designed to open a blocked heart vessel, restore blood flow to the heart and then dissolve into the blood vessel over time. ABSORB III is the first U.S. clinical trial to evaluate the potential benefits of Absorb in comparison to the medicated metallic heart stent, also called a drug-eluting stent, in patients with coronary artery disease (CAD), a form of heart disease.
CAD is a leading cause of death for men and women in the United States. Patients can experience symptoms such as chest pain and shortness of breath when the heart's demand for blood is more than the heart's ability to supply blood due to blockages in the vessels leading to the heart. These blockages are caused by the buildup of fat and cholesterol inside the vessels.
Since the 1970s, physicians have treated CAD patients with balloon angioplasty, metallic and drug-eluting metallic stents, allowing patients to avoid open heart surgery. Unlike a metallic stent that remains permanently in the body, Absorb is referred to as a scaffold to indicate that it is a temporary structure. The Absorb BVS is made of polylactide, a naturally dissolvable material that is commonly used in medical implants such as dissolving sutures.
The primary endpoint of the trial is target lesion failure, a combined measure of safety and efficacy, at one year. In addition, a subset of patients within the trial will be evaluated for novel endpoints such as vasomotion, a measure of how much natural motion returns to the vessel as Absorb dissolves into the arterial tissue.
Heart disease is the leading cause of death for both men and women in the United States and around the world. Each year, about 785,000 Americans have their first heart attack. Another 470,000 who have already experienced one or more heart attacks have another. Heart disease accounts for one of every six deaths that take place in the U.S.
Abbott is the first company in the world to test a bioresorbable vascular scaffold in patients in the United States.
About St.Vincent Heart Center of Indiana
St.Vincent Heart Center of Indiana (SVHCI) is one heart-specialty program offered at two locations: 106th Street and North Meridian, and on the campus of St.Vincent Indianapolis Hospital at 86th Street. The physician teams at both campuses are comprised of the cardiologists, electrophysiologists, interventional radiologists and surgeons of St.Vincent Medical Group (formerly The Care Group and CorVasc). SVHCI specializes in interventional radiology, interventional cardiology, cardiac catheterization, cardiac surgery, vascular medicine, thoracic procedures, transplants, Ventricular Assist Devices (VADs) and diagnostic testing for cardiovascular and non-cardiovascular issues. The program is home to the ACS/PCI/Indiana Heart Attack Network (IHAN)/Stent Center of Excellence; A-Fib Center of Excellence; Pediatric Cardiology Center of Excellence; Valve Center of Excellence; and Vascular Center of Excellence. Other programs and services include: the $49 HeartScan of Indiana; 24/7 Heart Emergency Unit; Women's Cardiac Risk Clinic; and The Sleep Center of Indiana. St.Vincent Heart Center of Indiana has been named by HealthGrades as number one in Indiana for seven years in a row (2006 – 2012) for cardiology and coronary interventional procedures and in the top five percent of all hospitals in the U.S. for overall cardiac services, cardiology and coronary interventional procedures for seven years in a row (2006 – 2012). It is also a Truven (formerlyThomson Reuters) 50 Top Cardiovascular Hospitals, and an Accredited Chest Pain Center.
About St.Vincent Medical Group
St.Vincent Medical Group is a multi-specialty group of primary care and specialty health providers. The medical group is physician-led and operated, and includes an array of integration options for providers such as clinical affiliations, joint ventures and employment. St.Vincent Medical Group creates a model of healthcare delivery that yields enhanced quality, efficiency, access and cost reductions. The Medical Group is part of St.Vincent Health, one of the state's largest healthcare employers with 22 health facilities serving 57 counties in Central and Southern Indiana. St.Vincent Health is a member of Ascension Health, the nation's largest not-for-profit and Catholic health care system.
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