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Abbott Receives CE Mark Approval for World's First Drug Eluting Bioresorbable Vascular Scaffold for Treatment of Coronary Artery Disease
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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
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Abbott will
Continue to Conduct Additional Trials to Further Study the
Device in Expanded Populations,
Including a 500-Patient Trial in Europe
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Full Commercial
Launch in Europe is Planned by End of 2011
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artist rendition
of Abbott's
bioresorbable DES |
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January
10, 2011 -- Abbott Park, Illinois -- Abbott 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™. |
"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." |
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Patrick W.
Serruys, MD |
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.
Source: Abbott
Vascular |
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