CORDIS Announces Results of Ten-Year CYPHER(R) Sirolimus-Eluting Coronary Stent Follow-Up

By Cordis Corporation, PRNE
Monday, August 30, 2010

The Publication of 10-Year Follow-Up Test Results on the First CYPHER(R) Sirolimus-Eluting Coronary Stent Patient Reveal the Stent's Outstanding Efficacy and Safety

STOCKHOLM, August 31, 2010 - Cordis Corporation, a worldwide leader in the development and manufacture
of interventional vascular technology, announced today at European Society of
Cardiology in Stockholm that the results of follow-up tests undertaken ten
years after the first patient was treated with a CYPHER(R) Sirolimus-eluting
coronary stent have proven outstanding long-term efficacy and safety and were
published earlier this year in "JACC: Cardiovascular Interventions". The
85-year-old patient was the first-ever patient to be treated with a CYPHER(R)
stent and made history by undergoing the longest term follow-up, ten years
later. The patient was the first person to be treated with a CYPHER(R) stent
in the non-randomized, in-human trial.

The patient, who was treated in 1999 with the CYPHER(R) stent at the age
of 75 after her coronary angiography showed a significant, single, de novo
lesion in the proximal left anterior descending (LAD) artery, under-went
further invasive follow-up revealing a sustained anti-proliferative effect of
the CYPHER(R) stent by both angiography and IVUS examination in 2009. The
patient also underwent an optical coherence tomography (OCT) assessment which
revealed a complete coverage of over 90% of the analyzed struts. This 10-Year
follow-up of the first-ever patient to be treated with CYPHER(R) took place
continuing a tradition of comprehensive testing for the most studied
drug-eluting stent in the world and reinforcing the CYPHER(R)
Sirolimus-eluting coronary stent's reputation for efficacy and safety. The
follow-up procedure was broadcast live during the 2009 meeting of the Latin
America Society of Interventional Cardiology (SOLACI, Rio de Janeiro -
Brazil
).

In a history of impressive CYPHER(R) stent data announcements at ESC in
Stockholm, Marie Claude Morice, M.D., Institut Cardiovasculaire Paris Sud,
had presented the initial results of the highly successful RAVEL trial, the
first CYPHER(R) stent randomized trial, at the Annual Congress of the
European Society of Cardiology in 2001. And this year at ESC in 2010, the
results of the 10-Year Follow-up of the first-ever patient to be treated with
CYPHER(R) Drug-eluting stent are discussed during Cordis Hands-On Tutorials
sessions.

Professor Eduardo Sousa, M.D., who led the team carrying out the
first-in-human trial in 1999 and the 10-year follow-up tests in 2009 in Sao
Paolo, Brazil, said, "We are very pleased with these results. This historic
follow-up has revealed a sustained anti-proliferative effect of the CYPHER(R)
stent by both angiography (in-stent late lumen loss of 0.10mm at 9 months as
compared to 0.11 at 48 months) and IVUS examination (in stent % of
obstruction of 1% at 4 months and 1,2,4, and 9 years). In addition, the
ten-year OCT assessment revealed a complete coverage of over 90% of the
analyzed struts. This is an impressive outcome and a testament to the
efficacy of the CYPHER(R) stent."

Marie Claude Morice, M.D., who led the initial RAVEL trial presented to
the European Society of Cardiology in 2001, explained, "The CYPHER(R)
Sirolimus-eluting coronary stent was the first of its kind and was a major
advance over bare-metal stents. A key trial showing the efficacy of CYPHER(R)
stent found that up to 5 years after receiving the stent, the risk of
restenosis of the artery is reduced by 60 - 70% compared to an uncoated
stent. It is also the longest-studied drug-eluting stent, with over 200
medical trials having been carried out and 155,000 patients observed. These
trials, from the initial RAVEL trial in 2001 to this latest ten-year
follow-up, have proven the CYPHER(R) stent's safety and effectiveness."

Campbell Rogers, M.D., Chief Scientific Officer and Global Head R&D at
Cordis, said, "We continue to be gratified by the outstanding performance of
CYPHER(R) compared with other drug-eluting stents. The breadth of clinical
safety and efficacy data and the long-term follow-up data on patient outcomes
associated with the CYPHER(R) stent are unmatched by the competition. These
historic long term results with the CYPHER(R) stent join ever-growing
datasets demonstrating superiority of the CYPHER(R) stent over other newer
DES competitors in diverse patient and lesion subsets and establish CYPHER(R)
stent as the gold standard treatment for patients with coronary disease
undergoing PCI."

Notes to Editors:

CYPHER(R) sirolimus-eluting coronary stent in detail

The CYPHER(R) stent releases a unique anti-inflammatory and
anti-proliferative-type medicine, sirolimus, into the artery wall over a
period of 90 days. The sirolimus helps limit the overgrowth of normal cells
while the artery heals. The CYPHER(R) stent has a unique closed-cell design
that allows the medicine to be distributed more evenly across the treated
area and that helps to keep the arteries open and the blood flowing to the
heart, reducing the chance of re-intervention in the treated area. Eighty
percent (80%) of the sirolimus is released during the first 30 days. The rest
is released by the end of 90 days.

About CYPHER(R) stent studies

The CYPHER(R) stent is the most studied drug-eluting stent in the world,
it has a proven safety profile out to 10 years and has been used in nearly 4
million patients worldwide. Today, with more than 9.000 citations on PubMed,
CYPHER(R) Sirolimus-eluting coronary stent is recognized as having the most
in depth clinical data, which marked it out as the most effective
drug-eluting stent available today with a safety profile presenting minimal
risks. CYPHER's(R) body of clinical evidence is completely unmatched by any
other drug-eluting stent. The CYPHER(R) stent has consistently proven to
control late loss across all vessel sizes and across a broad patient
population, even in the most complex types of patients such as patients with
diabetes and acute myocardial infarction. In fact, the CYPHER(R) stent has
shown more than 70% risk reduction in target lesion revascularization (TLR)
when compared with bare metal stents.

About the RAVEL trial

In 2000, patients were enrolled in the RAVEL Trial, the
first multi-center, randomized, double-blind, trial in history for
drug-eluting stents. The primary objective of RAVEL was the safety and
effectiveness of the CYPHER(R) Sirolimus-eluting stent in reducing
angiographic in stent late loss (at 6-month follow-up) in de novo native
coronary artery lesions as compared to the uncoated BX VELOCITY(TM)
balloon-expandable stent. The trial was conducted in 15 centers in Europe and
4 in Latin American and presented by Dr Marie Claude Morice at the Annual
Congress of the European Society of Cardiology in Stockholm on 4th September
2001
. The results from this trial surpassed expectations, demonstrating
virtual elimination of neointimal in-stent proliferation with no measurable
late loss (-0.01mm), a binary angiographic restenosis rate of 0%, and no
acute or late stent thrombosis.

    The above addressed timelines at one view

    1999       Cordis initiates the first clinical investigation of a
               drug-eluting stent. The First-In-Human trial, a safety and
               feasibility study is conducted in Sao Paolo/Brazil with Dr.
               Eduardo Sousa, and Rotterdam/The Netherlands with Dr. Patrick
               Serruys
    2000       Cordis embarks on the first multicenter, double-blind,
               randomized, drug-eluting stent trial in history - RAVEL
    2001       Dr. Marie-Claude Morice presents the initial results of the
               highly successful RAVEL trial, the first CYPHER(R) stent
               randomized trial, at the Annual Congress of the European
               Society of Cardiology in 2001
    2009       Dr. Eduardo Sousa, who led the team carrying out the
               first-in-human trial in 1999 initiated the 10-year follow-up
               tests in 2009 in Sao Paolo, Brazil with the first patient ever
               treated with CYPHER(R)
    2010       Results of the ten-year CYPHER(R) Sirolimus-eluting coronary
               stent follow-up are published

About Cordis Corporation

For more than 50 years, Cordis Corporation, a Johnson &
Johnson company, has been a worldwide leader in the development and
manufacture of interventional vascular technology. Through the company's
innovation, research and development, Cordis partners with interventional
cardiologists worldwide to treat millions of patients who suffer from
vascular disease.

Contact: Ulrike Domany, Director PA & Communication, Cordis & Biosense Webster EMEA, +43-1-36-025-396, +43-664-83-504-83

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