Abbott's ABSORB Heart Stent One Step Closer To FDA Approval

A new heart stent, or scaffold that actually absorbs into the body's system and was approved in Europe in January of this year, has demonstrated promising results after phase two trials. U.S. FDA approval still seems to be some time away however.


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


"The one-year data in these patients confirm earlier results seen at the six- and nine-month periods that the ABSORB device has the potential to effectively treat coronary artery disease with the possibility of restoring natural vessel function in a way not possible with permanent metallic implants. In addition, the one-year late loss seen with ABSORB is similar to what has been seen in a historical series of drug eluting stents, which is an encouraging indication that a bioresorbable scaffold like ABSORB might be able to offer the performance capabilities of a metallic drug eluting stent but with the added benefit of eventually dissolving away."


These results were presented during the American College of Cardiology's (ACC) 60th Annual Scientific Session and i2 Summit 2011 in New Orleans.


At one year, Abbott's ABSORB device demonstrated no reports of blood clots (thromboses). Importantly, of the patients' vessels that were assessed for vasomotor function, nearly all showed signs of vasomotion (constriction or dilation of the vessel) at one year, indicating that vessel movement was observed in the arteries of these patients as their vessels were no longer constrained by the scaffold, which had begun to be metabolized.


Charles A. Simonton, M.D., FACC, FSCAI, divisional vice president, Medical Affairs, and chief medical officer, Abbott Vascular continues:


"The positive one-year clinical results from the ABSORB trial provide support for the clinical performance of the device and its potential to change the way coronary artery disease is treated. Abbott is committed to continuing to build the body of clinical evidence supporting this novel therapy, and we are planning additional clinical trials this year."


Since a permanent metallic implant is not left behind, a patient's vessel treated with ABSORB may ultimately have the ability to move, flex and pulsate similar to an untreated vessel. Restoration of these naturally occurring vessel functions, or vascular restoration therapy (VRT), is one of the features that makes ABSORB a significant innovation for patients in the treatment of coronary artery disease.


The device is designed to restore blood flow by opening a clogged vessel and providing support to the vessel. Once the vessel can remain open without the extra support, ABSORB is designed to slowly metabolize and eventually be reabsorbed by the body.


Coronary heart disease (CHD) is the leading cause of death in the United States for men and women.


Coronary heart disease is usually caused by a condition called atherosclerosis, which occurs when fatty material and other substances form a plaque build-up on the walls of your arteries. This causes them to get narrow. As the coronary arteries narrow, blood flow to the heart can slow down or stop. This can cause chest pain (stable angina), shortness of breath, heart attack, and other symptoms, usually when you are active.