The Lancet Publishes Two-Year Results of Abbott’s Fully Bioabsorbable Drug Eluting Stent

By Prne, Gaea News Network
Wednesday, March 11, 2009

ABBOTT PARK, Illinois - Data Demonstrate Bioabsorbable Stent Is Absorbed Within Two Years,
Leaving Behind Blood Vessels that Appear to Move and Function Similar to
Untreated Vessels

A comprehensive analysis published today in The Lancet, one of the
world’s leading medical journals, from the ABSORB clinical trial demonstrated
that Abbott’s bioabsorbable drug eluting stent, currently in development,
successfully treated coronary artery disease and was absorbed into the walls
of treated arteries within two years. The two-year data also demonstrated
that after the bioabsorbable device was absorbed, the treated blood vessels
appeared to move and function similar to unstented arteries. Preliminary
findings from the 30-patient ABSORB trial were presented in October 2008 at
the Transcatheter Cardiovascular Therapeutics annual meeting in Washington,
D.C.

“Abbott’s bioabsorbable drug eluting stent leaves behind a vessel that
expands and contracts in a manner similar to a vessel that has never been
stented, which could be an advantage over permanent metal-based stent
implants,” said Patrick W. Serruys, M.D., Ph.D., professor of interventional
cardiology at the Thoraxcentre, Erasmus University Hospital, Rotterdam, the
Netherlands; lead author of The Lancet publication; and co-principal
investigator of the first phase of the ABSORB trial. “This bioabsorbable
device has the potential to provide optimal vessel scaffolding and drug
delivery capability over the crucial first several months after a stenting
procedure while avoiding the long-term restrictions of metallic stents.”

The ABSORB trial is the world’s first clinical trial evaluating a fully
bioabsorbable drug eluting coronary stent, and advanced imaging methods were
used to assess patient outcomes. As published in The Lancet, the first phase
of the ABSORB trial demonstrated the following key results:

- A zero percent rate of stent thrombosis (blood clot formation) for all
patients out to two years of follow up.

- No new major adverse cardiac events (MACE) between six months and two
years. At two years, the bioabsorbable device demonstrated a MACE rate
of 3.6 percent (one patient). MACE is defined as any event that
resulted in re-treatment of the treated artery lesion, heart attack or
cardiac death.

- Bioabsorption of the stent at two years after implantation, as
confirmed by an assessment of the stent struts using optical coherence
tomography (OCT).

- Restoration of vasomotion (ability of the blood vessel to contract and
expand) was observed at two years, with the drug acetylcholine used in
nine patients showing vasodilation in the previously stented area, and
the drug methergin used in seven patients showing vasoconstriction in
the previously stented area.

- Reduction in plaque area in treated arteries, corresponding to an
increase in blood flow between six months and two years, as confirmed
by intravascular ultrasound (IVUS) and virtual histology.

“Abbott’s bioabsorbable stent may be a major breakthrough in the
treatment of narrowed coronary arteries. The two-year ABSORB trial results
show that the bioabsorbable device did its job of relieving coronary
obstructions and preventing re-narrowing, and that it did this safely,” said
John Ormiston, M.D., medical director at Mercy Hospital in Auckland, New
Zealand and principal investigator in the first phase of the ABSORB trial.
“With no rigid stent remaining, vasomotion - the natural movement of the
artery - was restored, and the artery appeared to behave like a normal
artery. Who would want a permanent device if a temporary one may do the job
and then disappear?”

Abbott is the only company with long-term clinical data evaluating the
safety and performance of a bioabsorbable drug eluting coronary stent out to
two years. Abbott’s bioabsorbable everolimus eluting coronary device is made
of polylactic acid, a proven biocompatible material that is commonly used in
medical implants such as dissolvable sutures. As with a metallic stent,
Abbott’s bioabsorbable stent is designed to restore blood flow by propping a
clogged vessel open, and to provide support until the blood vessel heals.
Unlike a metallic stent, however, a bioabsorbable device is designed to be
slowly metabolized by the body and completely absorbed over time.

“Abbott has consistently been at the forefront of advances in
interventional cardiology - from the early days of angioplasty to our
continued success with bare metal stents and the market-leading XIENCE V drug
eluting stent. Our bioabsorbable device is another example of scientific
innovation leading to an interventional breakthrough,” said John M. Capek,
Ph.D., executive vice president, Medical Devices, Abbott. “Today’s data
publication in The Lancet confirms the promise our bioabsorbable device holds
as a vasorestorative therapy for patients with coronary artery disease.”

Abbott will begin enrolling patients in the second phase of its
international ABSORB clinical trial in the first half of 2009.

About the ABSORB Clinical Trial

The ABSORB trial is a prospective, non-randomized (open label), two-phase
study designed to enroll approximately 110 patients in Australia, Belgium,
Denmark, France, the Netherlands, New Zealand, Poland and Switzerland. Key
endpoints of the study include assessments of safety - MACE and stent
thrombosis rates - at 30 days, six, nine and 18 months, and one and two
years, with additional annual clinical follow-up for up to five years, as
well as an assessment of the acute performance of the bioabsorbable drug
eluting stent, including successful deployment of the stent. Other key
endpoints of the study include imaging assessments by angiography, IVUS, OCT,
and other state-of-the-art invasive and non-invasive imaging modalities at
six and 18 months, and at one or two years.

About XIENCE V

Abbott’s market-leading XIENCE V(TM) Everolimus Eluting Coronary Stent
System was approved by the U.S. Food and Drug Administration and launched in
July 2008, and was launched in Europe and other international markets in
October 2006. XIENCE V is an investigational device in Japan and is currently
under review by the Ministry of Health, Labour and Welfare and the
Pharmaceuticals and Medical Devices Agency.

Additional information about XIENCE V, including important safety and
effectiveness information, is available online at www.xiencev.com.

Everolimus, developed by Novartis Pharma AG, is a proliferation signal
inhibitor, or mTOR inhibitor, licensed to Abbott by Novartis for use on its
drug eluting stents. Everolimus has been shown to inhibit in-stent neointimal
growth in the coronary vessels following stent implantation, due to its
anti-proliferative properties.

About Abbott Vascular

Abbott Vascular, a division of Abbott, is one of the world’s leading
vascular care businesses. Abbott Vascular is uniquely focused on advancing
the treatment of vascular disease and improving patient care by combining the
latest medical device innovations with world-class pharmaceuticals, investing
in research and development, and advancing medicine through training and
education. Headquartered in Northern California, Abbott Vascular offers a
comprehensive portfolio of vessel closure, endovascular and coronary
products.

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 more than 72,000 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.

Source: Abbott

Media, Jonathon Hamilton, +1-408-845-3491, or Jennie Kim, +1-408-845-1755, or Financial, Tina Ventura, +1-847-935-9390, all of Abbott

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