Boston Scientific Announces FDA Approval and U.S. Launch of EPIC™ Vascular
New Self-Expanding Nitinol Stent Offers Balance of Flexibility and Radial
Strength for Enhanced Performance in Iliac Stenting Procedures
NATICK, Mass., May 17, 2012
NATICK, Mass., May 17, 2012 /PRNewswire/ --Boston Scientific Corporation
(NYSE: BSX) announces U.S. Food and Drug Administration approval and market
launch of the Epic™ Vascular Self-Expanding Stent System. The Epic Stent is
designed to open blocked arteries in patients with iliac artery stenosis, a
form of peripheral vascular disease associated with severe leg pain caused by
insufficient blood flow.
"The Epic Stent System demonstrates an excellent combination of flexibility,
radial force and deployment accuracy - all important attributes when treating
challenging atherosclerotic lesions in the iliac arteries," said Thomas
Shimshak, M.D., medical director at Wheaton Franciscan Heart Care in Racine,
WI. "The comprehensive stent size matrix should also help meet a variety of
clinical requirements when treating iliac arterial disease with no compromise
in deliverability or stent performance."
The Epic Stent is a self-expanding Nitinol stent designed to sustain vessel
patency, while providing enhanced visibility and accuracy during placement.
It employs an innovative Tandem Architecture™, which is engineered to provide
excellent stent flexibility while maintaining predictable radial force
characteristics and fracture resistance. The Epic Stent employs distal and
proximal radiopaque markers and all stent sizes are compatible with 6F
sheaths. The stent delivery system is offered in two shaft lengths (75 cm and
120 cm) for all sizes and is compatible with 0.035" guidewires.
In January, Boston Scientific announced that the ORION trial met its primary
clinical endpoint. The Epic Vascular Stent System demonstrated a low
nine-month major adverse events (MAE) rate of 3.4 percent in the
intent-to-treat population, which was significantly lower than the
pre-specified performance goal of 17 percent (p<0.001) based on historical
published outcomes for iliac stenting.
"The Epic Stent is another example of our commitment to innovation in treating
peripheral vascular disease, a growing worldwide health concern," said Jeff
Mirviss, president of the Boston Scientific Peripheral Interventions
Division. "This next-generation stent expands our growing peripheral
interventions portfolio, complementing the leading Express® LD
balloon-expandable iliac stent, and offering physicians a versatile new option
to treat patients with challenging lesions in the iliac arteries."
Iliac stenosis (narrowing) occurs when plaque accumulates within the arteries
that supply blood to the legs, which can lead to poor blood flow, claudication
(leg pain) and other complications. The disease can be treated with
medication, surgery or angioplasty.
The Epic Vascular Self-Expanding Stent System received CE Mark approval and
was launched in Europe and other international markets in 2009.
About Boston Scientific
Boston Scientific is a worldwide developer, manufacturer and marketer of
medical devices that are used in a broad range of interventional medical
specialties. For more information, please visit: www.bostonscientific.com.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933 and Section 21E of the Securities
Exchange Act of 1934. Forward-looking statements may be identified by words
like "anticipate," "expect," "project," "believe," "plan," "estimate,"
"intend" and similar words. These forward-looking statements are based on our
beliefs, assumptions and estimates using information available to us at the
time and are not intended to be guarantees of future events or performance.
These forward-looking statements include, among other things, statements
regarding product performance, clinical outcomes, our business plans and
competitive offerings. If our underlying assumptions turn out to be
incorrect, or if certain risks or uncertainties materialize, actual results
could vary materially from the expectations and projections expressed or
implied by our forward-looking statements. These factors, in some cases, have
affected and in the future (together with other factors) could affect our
ability to implement our business strategy and may cause actual results to
differ materially from those contemplated by the statements expressed in this
press release. As a result, readers are cautioned not to place undue reliance
on any of our forward-looking statements.
Factors that may cause such differences include, among other things: future
economic, competitive, reimbursement and regulatory conditions; new product
introductions; demographic trends; intellectual property; litigation;
financial market conditions; and future business decisions made by us and our
competitors. All of these factors are difficult or impossible to predict
accurately and many of them are beyond our control. For a further list and
description of these and other important risks and uncertainties that may
affect our future operations, see Part I, Item 1A – Risk Factors in our most
recent Annual Report on Form 10-K filed with the Securities and Exchange
Commission, which we may update in Part II, Item 1A – Risk Factors in
Quarterly Reports on Form 10-Q we have filed or will file hereafter. We
disclaim any intention or obligation to publicly update or revise any
forward-looking statements to reflect any change in our expectations or in
events, conditions or circumstances on which those expectations may be based,
or that may affect the likelihood that actual results will differ from those
contained in the forward-looking statements. This cautionary statement is
applicable to all forward-looking statements contained in this document.
CONTACT: Steven Campanini
Boston Scientific Corporation
Boston Scientific Corporation
SOURCE Boston Scientific Corporation
Press spacebar to pause and continue. Press esc to stop.