ABSORB III™ trial studying “dissolving” heart device
The Jim Moran Heart and Vascular Research Institute at Holy Cross Hospital in Fort Lauderdale is one of the first in the region to enroll patients with coronary artery disease (CAD) in a clinical trial studying a “dissolving ” cardiac stent to treat heart disease.
The ABSORB III™ clinical trial recently started in the United States. Interventional cardiologists at Holy Cross implanted the Absorb™ cardiac stent, 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.
Since the 1970s, physicians have treated patients with CAD with balloon angioplasty, metallic and drug eluting metallic cardiac stents, allowing many patients to avoid open heart surgery. Unlike a metallic stent that remains permanently in the body, Absorb™ dissolves over time.
“The goal of the Absorb cardiac stent is to restore the vessel to a more natural state and enable natural vessel function for improved long-term outcomes,” said Joshua Purow, MD, Principal Investigator.
Absorb™, is an investigational (not FDA approved) bioabsorbable vascular scaffold manufactured by the healthcare company Abbott. 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.
ABSORB III™ is the first U.S. clinical trial to evaluate the potential benefits and safety of Absorb™ in comparison to a medicated metallic cardiac stent, also called a drug eluting stent, in patients with CAD. Absorb BVS™ is approved for use outside of the US. More than 25,000 patients worldwide have received an Absorb BVS™. The clinical trial will enroll approximately 2,250 patients, the majority expected in the United States.
According to the Centers for Disease Control and Prevention, heart disease accounts for one of every six deaths in the nation. 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. These blockages are caused by the buildup of fat and cholesterol inside the vessel.
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