Abbott Receives CE Mark Approval for World's First Drug Eluting Bioresorbable Vascular Scaffold for Treatment of Coronary Artery Disease
By Abbott, PRNESunday, January 9, 2011
Abbott's Newest Innovation Can Treat a Patient's Blocked Heart Vessel and Then Dissolve, Leaving the Patient's Vessel Free of a Permanent Metallic Implant
ABBOTT PARK, Illinois, January 10, 2011 - Abbott (NYSE: ABT) announced today that it has received CE Mark approval
for the world's first drug eluting bioresorbable vascular scaffold (BVS) for
the treatment of coronary artery disease. Abbott's BVS device restores blood
flow by opening a clogged vessel and providing support to the vessel until
the device dissolves within approximately two years, leaving patients with a
treated vessel free of a permanent metallic implant. Abbott's BVS device will
be commercialized under the brand name ABSORB(TM).
"The CE Mark approval for ABSORB in Europe is a significant
accomplishment that validates the impressive clinical results that have been
observed with this device," said Patrick W. Serruys, M.D., Ph.D., professor
of interventional cardiology at the Thoraxcentre, Erasmus University
Hospital, Rotterdam, the Netherlands. "Abbott's ABSORB has the potential to
change the way patients with coronary artery disease are treated, as it does
what no other drug eluting coronary device has been able to do before -
completely dissolve and potentially restore natural vessel function in a way
not possible with permanent metallic implants."
ABSORB is made of polylactide, a proven biocompatible material that is
commonly used in medical implants such as resorbable sutures. Since a
permanent metallic implant is not left behind, a patient's vessel treated
with ABSORB may ultimately have the ability to move, flex and pulsate similar
to an untreated vessel. Restoration of these naturally occurring vessel
functions, or vascular restoration therapy (VRT), is one of the features that
makes ABSORB a significant innovation for patients in the treatment of
coronary artery disease. In addition, continuing research indicates that the
need to administer long-term dual anti-platelet therapy to patients may be
reduced because the temporary scaffold is completely resorbed.
"Our ABSORB technology has the potential to revolutionize the treatment
of coronary artery disease - with the prospect for positive therapeutic
outcomes resulting from its unique ability to treat a blocked vessel,
potentially restore natural vessel function and disappear within
approximately two years after implant," said Robert B. Hance, senior vice
president, vascular, Abbott. "Receiving CE Mark is a significant milestone on
the path to providing patients with new treatment options for coronary artery
disease. Abbott is committed to building the clinical and economic benefits
of this therapy in anticipation of making it widely available in Europe by
the end of 2012."
CE Mark approval for ABSORB in Europe was supported by data from the
ABSORB clinical trials, which included patient follow-up out to three years.
To further study the device in an expanded population, Abbott plans to
initiate a randomized, controlled clinical trial in Europe later this year.
The study will enroll approximately 500 patients at 40 centers throughout
Europe and will compare ABSORB to Abbott's XIENCE PRIME, which, together with
XIENCE V, is the market-leading drug eluting stent system in Europe. The
trial will provide additional data to support European commercialization and
reimbursement activities. A global trial, including the U.S. and other
geographies, is planned for later this year.
In addition to clinical trial product, ABSORB will be made available in
select sizes to a limited number of centers in Europe later this year and
into 2012. This will enable physicians in these centers to increase their
clinical experience with the technology and to continue to develop the
therapy. A full-scale European commercial launch of ABSORB with a broad size
matrix is planned by the end of 2012.
About the ABSORB Clinical Trials
The ABSORB trial is the world's first clinical trial evaluating a drug
eluting BVS for coronary artery disease, and Abbott is the only company with
long-term, four-year clinical data on a complete patient set evaluating the
safety and performance of a drug eluting BVS. 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 - major adverse cardiac events (MACE) and treated-site
thrombosis rates - at 30 days and at 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 BVS device, 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 and 18 months and at two, three
and five years.
Results from the first stage of the ABSORB trial with 30 patients
demonstrated that Abbott's BVS successfully treated coronary artery disease
and was resorbed into the walls of treated arteries within approximately two
years. Patients in this first stage of the ABSORB trial experienced no blood
clots (thrombosis) out to four years and no new MACE between six months and
four years (3.4 percent at four years).
Nine-month results from the 101 patients enrolled in the second stage of
the ABSORB trial showed that the MACE rate remained consistent at 5.0 percent
at nine months. There were no reports of blood clots in any of the 101
patients at nine months.
The ABSORB EXTEND trial is a single-arm study that will evaluate patients
at up to 100 centers in Europe, Asia Pacific, Canada and Latin America. The
trial will enroll approximately 1,000 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 the ABSORB Bioresorbable Vascular Scaffold
ABSORB is made of polylactide, a proven biocompatible material that is
commonly used in medical implants such as resorbable sutures. The device is
designed to restore blood flow by opening a clogged vessel and providing
support to the vessel. Once the vessel can remain open without the extra
support, ABSORB is designed to slowly metabolize and eventually be resorbed
by the body. Since a permanent implant is not left behind, a vessel treated
with ABSORB may ultimately have the ability to move, flex and pulsate similar
to an untreated vessel. Restoration of these naturally occurring vessel
functions, or vascular restoration therapy (VRT), is one of the features that
makes ABSORB a significant innovation for patients in the treatment of
coronary artery disease. ABSORB is currently under development and is not
available for sale in the United States.
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
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Media, Jonathon Hamilton, +1-408-624-0314, or Kathleen Rinehart, +1-408-845-1663, or Financial, Larry Peepo, +1-847-935-6722, or Tina Ventura, +1-847-935-9390, all of Abbott
Tags: Abbott, Abbott park, Illinois, January 10