Abbott receives CE Mark for world's first drug eluting bioresorbable
coronary stent
31 Jan 2011
Abbott (NYSE: ABT) has received the CE Mark for its 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, MD,
PhD, 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 US 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 centres in Europe
later this year and into 2012. This will enable physicians in these
centres 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 centres 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.