POSTED: Tuesday, July 2, 2013 - 11:48am
UPDATED: Tuesday, July 2, 2013 - 11:49am
Tyler, Texas (ETMC) — East Texas cardiologists are the first in Texas to implant an investigational bioresorbable vascular scaffold — similar to a stent except it eventually dissolves — for patients with heart disease as part of a national clinical trial.
Absorb, manufactured by the healthcare company Abbott, 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. The trial is being conducted by physicians of Tyler Cardiovascular Consultants and is being performed at the ETMC Cardiovascular Institute.
Dr. Robert Carney with Tyler CVC is the principal investigator and Dr. Frank Navetta performed the first implantation in the trial June 21.
“This Absorb scaffold serves the same function as a traditional metallic stent, however over the course of time it dissolves and is reabsorbed into the body,” said Dr. Carney. “This is truly revolutionary. In effect, the scaffold has the potential to completely repair the blocked artery and then disappear as though it were never there.”
Coronary artery disease or CAD is a leading cause of death for men and women. Patients with CAD can experience symptoms such as chest pain and shortness of breath when the demand for blood by the heart is more than the heart's ability to supply blood due to blockages in the coronary arteries, the vessels that carry blood to the heart muscle. These blockages are caused by the build-up of fat and cholesterol inside the vessel.
Since the 1980s, physicians have treated patients with CAD with balloon angioplasty, bare metal and drug-coated 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 U.S.
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 dissolves except for a pair of tiny metallic markers, which help guide placement and remain in the artery to enable a physician to see where the device was placed.
The ABSORB III clinical trial will enroll approximately 2,250 patients, the majority in the U.S. The primary endpoint of the trial is target lesion failure, a combined measure of the device’s safety and effectiveness, 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.
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.