Abbott Announces Positive Six-Month Results From the World's First Clinical Trial of a Fully Bioabsorbable Drug-Eluting Coronary
24 März 2007 - 5:00PM
PR Newswire (US)
Abbott's Bioabsorbable Stent Technology Holds Promise as
Future-Generation Treatment Option for Physicians Treating Patients
with Coronary Artery Disease ABBOTT PARK, Ill., March 24
/PRNewswire-FirstCall/ -- Abbott today announced positive results
from ABSORB, the world's first clinical trial evaluating the
overall safety and performance of a fully bioabsorbable drug-
eluting stent platform for the treatment of coronary artery
disease. Six- month results from the first 30 patients in the
trial, presented at the 56th Annual American College of Cardiology
Scientific Session in New Orleans, demonstrated no stent thrombosis
and a low (3.3 percent) hierarchical rate of ischemia-driven Major
Adverse Cardiac Events (MACE), such as heart attack or repeat
intervention. "The encouraging results from the first 30 patients
of ABSORB suggest that drug-eluting bioabsorbable stent
technologies may be a promising future therapy option for
physicians treating patients with heart disease," said Patrick W.
Serruys, M.D., Ph.D., professor of interventional cardiology at the
Thoraxcentre, Erasmus University Hospital, Rotterdam, who is
co-principal investigator of the study. "A drug eluting stent that
would eventually disappear after restoring blood flow is an
exciting concept that we look forward to further exploring." The
single MACE event reported was a non-Q-wave myocardial infarction.
The same patient underwent a repeat intervention that occurred at
the site of the original procedure, resulting in an overall target
lesion revascularization rate of 3.3 percent. The trial results
confirmed that the treatment effect of everolimus in the
bioabsorbable stent is similar to that observed in Abbott's studies
of metallic drug-eluting stents, with everolimus actively
inhibiting tissue growth into the artery. The rate of device
success (successful placement of the bioabsorbable stent at the
site of the lesion) was 93.5 percent. Abbott's everolimus-eluting
bioabsorbable stent is made of polylactic acid, a proven
biocompatible material that is commonly used in medical implants
such as dissolvable sutures. As with a metallic stent, the
bioabsorbable stent is designed to restore blood flow by propping
the vessel open, providing support until the blood vessel heals.
Unlike a metallic stent, a bioabsorbable stent is designed to be
slowly metabolized by the body and completely absorbed over time.
"Based on these encouraging safety results, Abbott will continue to
advance this technology by enrolling the next cohort of patients in
the ABSORB study in Europe and New Zealand," said John M. Capek,
Ph.D., senior vice president, Abbott Vascular. "The next phase of
the ABSORB study will utilize a next-generation bioabsorbable
everolimus-eluting stent that incorporates several advancements
designed to improve strength and deliverability." About the ABSORB
Trial The ABSORB trial is a prospective, non-randomized (open
label) study designed to enroll up to 60 patients in Belgium,
Denmark, France, New Zealand, Poland and The Netherlands. Key
endpoints of the study include assessments of safety -- MACE and
stent thrombosis (blood clot formation) rates -- at 30, 180 and 270
days, with an annual follow-up for up to five years, and successful
deployment of the bioabsorbable drug-eluting stent. Other key
endpoints of the study include follow-up measurements assessed by
angiography, IVUS, and state- of-the-art imaging modalities at 180
days and two years, as well as a new noninvasive technique in a
subset of patients at 18 months. The co-principal investigator of
the study is John Ormiston, M.D., of Mercy Hospital in Auckland,
New Zealand. For images of Abbott's bioabsorbable stent and other
information, please visit the company's online ACC newsroom at
http://www.abbottvascular.com/ACCpresskit . About Abbott Vascular
Abbott Vascular, a division of Abbott, is one of the world's
leading vascular care businesses. Abbott Vascular is uniquely
focused on advancing the treatment of vascular disease and
improving patient care by combining the latest medical device
innovations with world-class pharmaceuticals, investing in research
and development, and advancing medicine through training and
education. Headquartered in Northern California, Abbott Vascular
offers a comprehensive portfolio of vessel closure, endovascular
and coronary products that are recognized internationally for their
safety and effectiveness in treating patients with vascular
disease. 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 65,000
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/ . DATASOURCE: Abbott
CONTACT: Media, Karin Bauer Aranaz, +1-415-859-3414, , Nicole
Osmer, +1-650-454-0504, , or Financial, Tina Ventura,
+1-847-772-5006, , all of Abbott Web site: http://www.abbott.com/
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