PROMUS Element(TM) Stent Demonstrates Exceptional Safety and Effectiveness in PLATINUM Small Vessel Study

By Boston Scientific Corporation, PRNE
Sunday, May 22, 2011

NATICK, Massachusetts and PARIS, May 23, 2011 -

- 12-Month Clinical Data Demonstrate Low Adverse Event Rates for Boston
Scientific's 2.25 mm PROMUS Element Platinum Chromium Stent

Boston Scientific Corporation (NYSE: BSX) today announced
12-month results from its PLATINUM Small Vessel study, demonstrating
excellent safety and effectiveness outcomes for the 2.25 mm PROMUS
Element(TM) Everolimus-Eluting Platinum Chromium Stent System in treating
small vessel coronary disease. The study is a global, prospective,
single-arm, subtrial of the PLATINUM clinical program. It compares the PROMUS
Element Stent (2.25 mm) in 94 patients with small vessels (≥2.25 to <2.50
mm reference vessel diameter and ≤28 mm lesion length) to a pre-specified
performance goal based on results from patients treated with the TAXUS(R)
Express(R) Paclitaxel-Eluting Stent.

Analysis of the data was presented at the annual EuroPCR
Scientific Program in Paris by Ian T. Meredith, M.B.B.S., Ph.D., Professor of
Cardiology and Medicine, Monash University, and Executive Director of Monash
Cardiovascular Research Center, Monash Medical Centre, Clayton, Victoria,
, and Co-Principal Investigator for the PLATINUM clinical program.

"The PLATINUM Small Vessel data demonstrate exceptionally low
rates of revascularization, while reporting no myocardial infarction or stent
thrombosis at one year in patients treated with the 2.25 mm PROMUS Element
Stent," said Professor Meredith. "These results are impressive, especially
considering the small vessel diameter in this patient population."

The PLATINUM Small Vessel study met its primary endpoint of
target lesion failure (TLF) at 12 months with a rate of 2.4 percent for the
2.25 mm PROMUS Element Stent in the per protocol population compared to a
pre-specified performance goal of 21.1 percent (p<0.001) based on historical
outcomes for the 2.25 mm TAXUS Express Stent. Components of TLF in the per
protocol population included cardiac death related to the target vessel (2.4
percent), myocardial infarction related to the target vessel (MI, 0.0
percent) and ischemia-driven target lesion revascularization (TLR, 0.0
percent). Clinical outcome rates at 12 months in the intent-to-treat
population were also low for cardiac death (3.3 percent), MI (0.0 percent),
TLR (2.2 percent) and ARC definite/probable stent thrombosis (0.0 percent).

"The PLATINUM Small Vessel data build on the positive outcomes
from the PLATINUM Workhorse and QCA studies, confirming the successful
transfer of favorable outcomes associated with everolimus to the novel
platinum chromium (PtCr) stent design," said Keith D. Dawkins, M.D., Senior
Vice President and Chief Medical Officer for Boston Scientific's Cardiology,
Rhythm and Vascular Group. "The results demonstrate a highly effective PtCr
small vessel stent platform with an excellent safety profile."

"Boston Scientific has led development of drug-eluting stents
for small vessels, which now represent approximately 10 percent of coronary
stenting procedures," said Hank Kucheman, Executive Vice President and Group
President, Cardiology, Rhythm and Vascular for Boston Scientific. "This
evaluation of the 2.25 mm PROMUS Element Stent reconfirms our commitment to
providing a complete range of solutions and sizes for physicians and their

The PLATINUM clinical program is evaluating the safety and
effectiveness of the PROMUS Element Stent in five multi-center studies
totaling more than 1,800 patients, including a global, randomized, pivotal
controlled trial in workhorse lesions, and single-arm studies evaluating
small vessels, long lesions, pharmacokinetics, and quantitative coronary
angiography and intravascular ultrasound data.

The PROMUS Element Stent System received CE Mark approval and
was launched in Europe and other international markets in 2009. It features
an innovative PtCr alloy and new stent design to offer greater radial
strength, exceptional deliverability and high visibility. The thin-strut
stent is designed for improved conformability, minimal recoil and uniform
lesion coverage and drug distribution. The advanced low-profile delivery
system, coupled with the radiopacity, facilitates precise delivery of the
stent across challenging lesions.

The Company anticipates FDA approval for the PROMUS Element
Stent, including the 2.25 mm PROMUS Element Stent, in mid 2012. In the U.S.,
it is an investigational device, limited by applicable law to investigational
use and not available for sale.

About Boston Scientific

Boston Scientific is a worldwide developer, manufacturer and
marketer of medical devices whose products are used in a broad range of
interventional medical specialties. For more information, please visit:

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    CONTACT: Géraldine Varoqui
             Head of Communications
             Boston Scientific EMEA


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