Wednesday, May 22, 2013
Winchester Medical Center Enrolls Patients in Clinical Trial for New Dissolvable Device for Heart Disease
Interventional cardiologists at Winchester Medical Center are the first in Virginia to implant Absorb™, an investigational bioresorbable vascular scaffold (BVS), as part of the ABSORB III clinical trial initiated in the United States earlier this year 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 a 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 worldwide. Patients with CAD can experience symptoms such as chest pain and shortness of breath when the demand for blood to the heart is more than the heart's ability to supply it due to blockages in the vessels that carry blood to the heart. These blockages are caused by the buildup of fat and cholesterol inside the vessel.
Since the late 1970s, physicians have treated patients with CAD with balloon angioplasty, metallic stents, and then drug eluting metallic stents, allowing many patients to avoid open heart surgery. About a decade ago, scientists at Abbott started development of Absorb and now Abbott is the first company in the world to begin testing a bioresorbable vascular scaffold in patients in the United States.
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. Abbott's Absorb BVS is made of polylactide, a naturally dissolvable material that is commonly used in medical implants such as dissolving sutures.
The ABSORB III clinical trial will enroll approximately 2,250 patients, the majority in the United States. The primary endpoint of the study is to determine, after one year, if the vessel treated with the Absorb stent is still open and with normal blood flow. 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.
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.
About Winchester Medical Center
Winchester Medical Center is a 445-bed nonprofit regional referral facility serving residents of the “top” of Virginia, the eastern panhandle of West Virginia and western Maryland. The WMC Heart & Vascular Center has had a consistently well-respected, comprehensive program since 1980, when it opened the region’s first cardiac catheterization lab, and four years later, performed its first open heart surgery. Since 2004 the Valley Health Clinical Research Department has managed more than 100 clinical trials to investigate the efficacy of new drugs and devices before they are approved for use in the U.S. www.valleyhealthlink.com
Abbott is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare: diagnostics, medical devices, nutritionals and branded generic pharmaceuticals. Abbott Vascular is the world's leader in drug eluting stents. Abbott Vascular has an industry-leading pipeline and a comprehensive portfolio of market-leading products for cardiac and vascular care, including products for coronary artery disease, vessel closure, endovascular disease and structural heart disease. www.abbott.com
Absorb fact sheet, infographics, animation, b-roll and images can all be found at www.absorbmediakit.com