Abbott's Fully Bioresorbable Vascular Scaffold Technology Continues to Demonstrate Strong Clinical Results
By Abbott, PRNETuesday, September 21, 2010
Positive Data at Six and Nine Months Affirm Groundbreaking Potential of Abbott's Bioresorbable Vascular Scaffold as a Promising Alternative to Coronary Stenting
ABBOTT PARK, Illinois, September 22, 2010 - Abbott (NYSE: ABT) today announced positive nine-month results from the
first 45 patients enrolled in the second stage of the ABSORB trial. At nine
months, Abbott's bioresorbable vascular scaffold (BVS) demonstrated strong
results that remained consistent with the six-month data from the same
45-patient group, with the rate of major adverse cardiac events (MACE)
unchanged at 4.4 percent and no reports of blood clots (thromboses). These
results were presented during the Cardiovascular Research Foundation's 22nd
annual Transcatheter Cardiovascular Therapeutics (TCT) conference in
Washington, D.C.
"I am impressed with how consistent the BVS data have been to date, as
the nine-month data are compelling and supportive of earlier positive
results," said John Ormiston, M.D., medical director at Mercy Hospital in
Auckland, New Zealand, and co-principal investigator for the ABSORB trial.
"In addition to the positive safety data we've seen to date, the late loss
rate of 0.19 millimeters reported at six months is comparable to a metallic
drug eluting stent, and may address a limitation of metal stents by not
leaving metal in the artery. This technology is truly a step forward for the
field of interventional cardiology, and I am excited about the prospect of
treating patients with this revolutionary product."
Abbott also presented six-month results for all 101 patients enrolled in
the second stage of the ABSORB trial. In this complete patient population,
the MACE rate remained consistent, with a nominal increase from 4.4 percent
at six months in the first 45 patients to 5.0 percent at six months in all
101 patients. There were no reports of blood clots in any of the 101
patients.
"We are pleased with the progress of ABSORB and the encouraging data we
continue to see from the trial in the entire cohort of more than 100
patients," 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 findings
to date show that the device appears to effectively treat coronary artery
disease with the possibility of restoring natural vessel function in a way
that is not possible with permanent implants."
Abbott's BVS is under investigation in two clinical studies, ABSORB and
ABSORB EXTEND, and is currently not available for sale anywhere in the world.
The BVS is made of polylactide, a proven biocompatible material that is
commonly used in medical implants such as resorbable 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 slowly metabolize and eventually be resorbed by the body. Since a
permanent implant is not left behind, a vessel treated with a BVS may
ultimately have the ability to move, flex and pulsate similar to an untreated
vessel. The potential to restore these naturally occurring vessel functions,
or vascular restoration, is one of the features that makes Abbott's BVS
revolutionary in the treatment of coronary artery disease.
About the ABSORB Clinical Trials
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 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, 24 and 36 months.
The ABSORB EXTEND trial is a single-arm study that is currently enrolling
patients at up to 100 centers in Europe, Asia Pacific, Canada and Latin
America. The trial will enroll approximately 1,000 patients, including
patients with more complex coronary artery disease.
Abbott's bioresorbable technology delivers everolimus, an
anti-proliferative drug. Everolimus is developed by Novartis Pharma AG and is
licensed to Abbott by Novartis for use on its drug eluting vascular devices.
Everolimus has been shown to inhibit treated-site neointimal growth in the
coronary vessels following vascular device implantations, 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 nearly 90,000 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.
Media, Jonathon Hamilton, +1-408-624-0314, or Financial, Larry Peepo, +1-847-935-6722, both of Abbott
Tags: Abbott, Abbott park, Illinois, September 22, United Kingdom