When patients undergo surgery to unblock clogged arteries, it has been standard procedure to insert a coronary artery stent made up of a metal framework. However, in a breakthrough innovation, these stints may now be placed to unclog vessels, and then will dissolve within approximately two years, leaving patients with a treated vessel free of a permanent metallic implant.

Typically, as the stent is a foreign object it incites an immune response. This may cause scar tissue to rapidly grow over the stent and there is a strong tendency for clots to form at the site where the stent damages the arterial wall. Since platelets are involved in the clotting process, patients must currently take dual antiplatelet therapy afterwards, usually clopidogrel and aspirin for one year and aspirin indefinitely. In order to reduce the treatment, new generation of stent has been developed with biodegradable polymer.

Abbott, a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, has gained European approval of the world’s first drug eluting bioresorbable vascular scaffold (BVS) for the treatment of coronary artery disease and will be branded as “ABSORB.”

Patrick W. Serruys, M.D., Ph.D., professor of interventional cardiology at the Thoraxcentre, Erasmus University Hospital, Rotterdam, the Netherlands explains:

“The CE Mark approval for ABSORB in Europe is a significant accomplishment that validates the impressive clinical results that have been observed with this device. Abbott’s ABSORB has the potential to change the way patients with coronary artery disease are treated, as it does what no other drug eluting coronary device has been able to do before; completely dissolve and potentially restore natural vessel function in a way not possible with permanent metallic implants.”

Since a permanent metallic implant is not left behind, a patient’s vessel now may ultimately have the ability to move, flex and pulsate similar to an untreated vessel. This process is called vascular restoration therapy (VRT). Further research indicates that the anti-platelet therapy to patients may be reduced because the temporary scaffold is completely resorbed. ABSORB is made of polylactide, a proven biocompatible material that is commonly used in medical implants such as resorbable sutures. The device is designed to restore blood flow by opening a clogged vessel and providing support to the vessel.

The coronary arteries that run on the surface of the heart are called epicardial coronary arteries. These arteries, when healthy, are capable of autoregulation to maintain coronary blood flow at levels appropriate to the needs of the heart muscle. These relatively narrow vessels are commonly affected by atherosclerosis and can become blocked, causing angina or a heart attack. Robert B. Hance, senior vice president at Abbott continues:

“Our ABSORB technology has the potential to revolutionize the treatment of coronary artery disease with the prospect for positive therapeutic outcomes resulting from its unique ability to treat a blocked vessel, potentially restore natural vessel function and disappear within approximately two years after implant. Receiving CE Mark is a significant milestone on the path to providing patients with new treatment options for coronary artery disease. Abbott is committed to building the clinical and economic benefits of this therapy in anticipation of making it widely available in Europe by the end of 2012.”

European approval was supported by data from the ABSORB clinical trials, which included patient monitoring for three years. In 2011 there are plans to initiate a randomized, controlled clinical trial in Europe. The trial will provide additional data to support European commercialization and reimbursement activities.

A global trial, including the U.S. and other geographies at up to 100 centers in Europe, Asia Pacific, Canada and Latin America is planned and Abbott hopes this will prove as a global solution to better coronary stint procedures.

SOURCE: Abbott

Written by Sy Kraft, B.A.