Beaumont Health System launches research trial of bioresorbable heart scaffold
Beaumont Health System has joined a multicenter, international research study of a new temporary heart device that helps keep an artery open following angioplasty, then is broken down and absorbed by the body.
The research will compare the effectiveness of the new "disappearing" device, the AbsorbTM Bioresorbable Vascular Scaffold made by health care company Abbott, with drug-eluting, metal stents that are commonly placed in heart arteries as a permanent implant. Absorb is referred to as a scaffold to indicate it is temporary in nature, unlike a permanent metallic stent. It is made of polylactide, a material commonly used in medical implants such as dissolving sutures.
Coronary artery stents were approved for use in the United States in 1994. Similar to a mesh tube, stents prop open a heart artery after a blockage is cleared with a procedure called angioplasty.
In angioplasty, a doctor threads a catheter, or hollow tube, into the arteries of the heart through a small incision in the groin or wrist, with a tiny balloon at its tip that, once inflated, pushes a blockage against the artery wall to open the artery and improve blood flow to the heart. Angioplasty is often followed by insertion of a stent coated with medication, called a drug-eluting stent, at the site of the blockage to keep the vessel open and prevent renarrowing. Metallic stents are a permanent implant in the wall of the artery.
"Stents have revolutionized the treatment of heart blockages by helping many patients to avoid having repeat angioplasty procedures and in some cases open-heart surgery," says Amr Abbas, M.D., Beaumont's director of interventional cardiology research and the study's principal investigator. "This new bioabsorbable vascular scaffold is the latest technique in heart treatment in interventional cardiology."
Research has shown that the support of a coronary stent is only needed for a few months after implantation while the artery wall is healing. Although researchers hoped to create a temporary scaffold that dissolved after doing its job, there were many scientific challenges. 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.
The Absorb™ BVS is available in Europe, Middle East and parts of Asia. It is an investigational device not available for sale in the U.S.
ABSORB III will enroll approximately 2,250 patients, the majority in the U.S.
For more information on the Beaumont study, including enrollment criteria, call Diedre Brunk, Beaumont Cardiology Research at 248-898-5580.