Abbott Announces Positive Data From ABSORB Trial on Its Bioresorbable Vascular Scaffold Technology
By Abbott, PRNESunday, March 14, 2010
New Data From Second Phase Shows No Blood Clots, No Repeat Procedures and Very Low MACE in Patients Treated with Abbott's Innovative Device
ATLANTA, March 15, 2010 - Abbott (NYSE: ABT) today announced positive 30-day results from the first
101 patients enrolled in the second phase of the ABSORB trial. Patients
treated with Abbott's bioresorbable vascular scaffold (BVS), under clinical
investigation in Europe, demonstrated no cases of blood clots (thrombosis),
no need for repeat procedures (ischemia-driven target lesion
revascularization) and a very low rate of major adverse cardiac events
(MACE(1) rate of 2.0 percent) at 30 days. These results build on the
long-term success Abbott has seen with the BVS technology in the first phase
of the ABSORB trial, which has generated positive data on 30 patients out to
three years. Data from the second phase of the trial was presented at the
American College of Cardiology's 59th annual scientific session in Atlanta.
"The positive 30-day results reaffirm my belief that a device that
bioresorbs, or disappears, into the body after restoring blood flow is the
next logical step in the treatment of cardiovascular disease," said Patrick
W. Serruys, M.D., Ph.D., professor of interventional cardiology at the
Thoraxcentre, Erasmus University Hospital, Rotterdam, the Netherlands, and
principal investigator for the ABSORB trial. "The continuing positive results
of the ABSORB trial and the clinical benefits demonstrated to date by
Abbott's bioresorbable technology show promise that a bioresorbable scaffold
is on its way to becoming a clinical reality and will be the next revolution
in interventional cardiology."
This second phase of the ABSORB clinical trial (Cohort B) enrolled 101
patients from 12 centers in Europe, Australia and New Zealand, and
incorporates device enhancements designed to improve deliverability and
vessel support. Abbott is the only company with long-term, three-year
clinical data on a complete patient set evaluating the safety and performance
of a fully bioresorbable drug eluting scaffold.
"The encouraging 30-day results show that Abbott's BVS is able to restore
blood flow with no cases of blood clots or repeat procedure, suggesting that
there could be important clinical benefits for patients," said Charles A.
Simonton, M.D., FACC, FSCAI, divisional vice president, Medical Affairs, and
chief medical officer, Abbott Vascular. "If Abbott's bioresorbable technology
continues to perform well in clinical trials, it has the potential to become
the new standard of care for patients with coronary artery disease."
Abbott's investigational BVS is made of polylactide, a proven
biocompatible material that is commonly used in medical implants such as
dissolving sutures. The bioresorbable technology is designed to restore blood
flow by opening a clogged vessel and providing support until it is healed.
Once the vessel can remain open without the extra support, the bioresorbable
scaffold is designed to be slowly metabolized by the body, and is completely
dissolved over time. Since a permanent implant is not left behind, a vessel
treated with BVS has the ability to ultimately move, flex and pulsate similar
to an untreated vessel. The potential to restore these naturally occurring
vessel functions, or vascular restoration therapy, is what makes Abbott's BVS
unique in the field of cardiology.
About the ABSORB Clinical Trial
The ABSORB trial is a prospective, non-randomized (open label), two-phase
study that enrolled 131 patients from Australia, Belgium, Denmark, France,
the Netherlands, New Zealand, Poland and Switzerland. Key endpoints of the
study include assessments of safety - MACE and treated site thrombosis rates
- at 30 days; six, nine, 12, 18 and 24 months; with additional annual
clinical follow-up for up to five years, as well as an assessment of the
acute performance of the bioresorbable vascular scaffold, including
successful deployment of the system. Other key endpoints of the study include
imaging assessments by angiography, intravascular ultrasound (IVUS), optical
coherence tomography (OCT), and other state-of-the-art invasive and
non-invasive imaging modalities at six, 12, 18 and 24 months.
Abbott's bioresorbable technology delivers everolimus, a drug that
inhibits tissue proliferation. Everolimus, developed by Novartis Pharma AG,
is a proliferation signal inhibitor, or mTOR inhibitor, licensed to Abbott by
Novartis for use on its vascular devices. Everolimus has been shown to
inhibit treated site neointimal growth in the coronary vessels following
vascular device implantation, due to its anti-proliferative properties.
About Abbott Vascular
Abbott Vascular is a global leader in cardiac and vascular care with
market-leading products and an industry-leading pipeline. Abbott Vascular
offers a comprehensive cardiac and vascular devices portfolio, including
products for coronary artery disease, vessel closure, endovascular disease,
and structural heart 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 approximately 83,000 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 www.abbott.com.
(1) MACE is a composite measure of key efficacy and safety endpoints and
includes cardiac death, heart attack (myocardial infarction) and
ischemia-driven target lesion revascularization.
Media, Jonathon Hamilton, +1-408-624-0314, or Jennie Kim, +1-408-332-4176, or Financial, Larry Peepo, +1-847-935-6722, or Tina Ventura, +1-847-935-9390, all of Abbott
Tags: Abbott, Atlanta, Europe, georgia, March 15