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Abbott Announces Positive Data From ABSORB Trial on Its Bioresorbable Vascular Scaffold Technology
New Data From Second Phase Shows No Blood Clots, No Repeat Procedures and Very Low MACE in Patients Treated with Abbott's Innovative Device
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March 15, 2010 -- Atlanta, GA --
Abbott 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 (MACE¹ 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.
Patrick
W. Serruys, MD |
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"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.
Source: Abbott Vascular
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