ATLANTA, March 12 /PRNewswire-FirstCall/ -- Abbott today announced the first clinical results for its investigational ZoMaxx(TM) Drug-Eluting Coronary Stent System. Data from ZOMAXX IVUS, a 40-patient, single-arm, clinical, angiographic and intravascular ultrasound (IVUS) trial sponsored by Abbott, demonstrated 100 percent procedural success, no major adverse cardiac events and minimal late lumen loss (vessel diameter loss) during the four- month follow-up period. The objective of the study was to evaluate the safety and performance of ZoMaxx for the treatment of coronary artery disease. These data were presented at the 2006 American College of Cardiology Scientific Session in Atlanta.
"The results of the ZOMAXX IVUS study are encouraging as they demonstrated that controlled release of zotarolimus minimized neointimal proliferation [tissue growth inside the vessel] over the first four months following stent implantation," said Alexandre Abizaid, M.D., Ph.D., Instituto Dante Pazzannese, Sao Paulo, Brazil, and principal investigator of the ZOMAXX IVUS clinical trial. "The ZoMaxx stent is a highly deliverable device that is easy to see under X-ray. It shows promise as a percutaneous treatment for patients with coronary artery disease."
"These four-month results from ZOMAXX IVUS reinforce Abbott's commitment to deliver the new ZoMaxx drug-eluting stent system to the interventional community, which we feel will significantly advance the treatment of coronary artery disease," said Robert B. Hance, president of Abbott Vascular.
About the ZOMAXX IVUS Clinical Trial
ZOMAXX IVUS was a clinical, angiographic and intravascular ultrasound (IVUS) trial conducted in 40 patients with a mean age of 59 years (+/- 9). Eighty percent of patients had hyperlipidemia (high cholesterol), 40 percent had diabetes, and 40 percent had a prior heart attack. The mean lesion length stented was 14.4 mm (+/- 3.3).
Before treatment with a ZoMaxx stent, percent diameter stenosis (DS), the percent of vessel blocked with disease, was 70% (+/- 10). Directly after treatment with ZoMaxx, percent diameter stenosis improved to 5.1 percent (+/- 5.3) inside the stent (in-stent) and 19 percent (+/- 7) in-segment, or within the stent plus 5 mm on either side of it.
Late lumen loss, a measure of the change in vessel diameter between the time immediately following stent placement and (in the case of ZOMAXX IVUS) at four-months, was 0.20 mm (+/- 0.35) in-stent and 0.17 mm (+/- 0.35) in- segment. In-stent net volume obstruction, the amount of blockage that re- formed inside the stent in the four-months following the initial procedure, was 6.5 percent (+/- 6.2).
The ZoMaxx stent was delivered with 100 percent success, and no major adverse cardiac events (MACE) occurred during the procedure or during the four months of follow up.
About The ZoMaxx Drug-Eluting Coronary Stent System
The ZoMaxx Drug-Eluting Coronary Stent System features proprietary application of a biologically inert coating called Pharmacoat(TM), intended to enable steady drug elution over time, and proprietary application of Abbott's patent-protected immunosuppressant drug, zotarolimus, which has been studied for the reduction of vessel re-narrowing. Zotarolimus is the only drug designed exclusively for use on drug-eluting stents. The system's TriMaxx(TM) stent platform is made of stainless steel and tantalum to enable optimal visibility under X-ray, with extremely thin struts and an ultra-low crossing profile to facilitate ease of stent placement.
Pharmacoat is licensed to Abbott from Biocompatibles International plc.
About Abbott Vascular
Abbott Vascular, a division of Abbott, is transforming the treatment of vascular disease, combining the latest medical device innovations with world- class pharmaceuticals to advance medicine and improve patient care. Abbott Vascular offers a comprehensive portfolio of vessel closure, endovascular and coronary products that are recognized internationally for their safety, effectiveness and ease of use in treating patients with vascular disease. Abbott Vascular is headquartered in Redwood City, Calif. For more information, visit http://www.abbottvascular.com/ .
About Abbott
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs approximately 60,000 people and markets its products in more than 130 countries.
Abbott's news releases and other information are available on the company's Web site at http://www.abbott.com/ .
