The Boston Scientific PROMUS Element Platinum Chromium Stent Demonstrates Positive Outcomes in Patients with Long Coronary Lesions
PLATINUM Long Lesion Clinical Results Presented at TCT 2012 Show No Heart Attack or Stent Thrombosis at Two-Year Follow-Up
NATICK, Mass., Oct. 23, 2012 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) reports clinical endpoint data from the PLATINUM Long Lesion trial, demonstrating positive outcomes for the PROMUS Element™ Everolimus-Eluting Platinum Chromium (PtCr) Stent System in patients with long coronary lesions. Results were presented today by Paul S. Teirstein, M.D., of the Scripps Clinic in La Jolla, California, and Co-Principal Investigator of the trial, at the 24th Annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation.
"The PROMUS Element Stent achieved impressive clinical outcomes in this patient population with long lesions," said Dr. Teirstein. "This durable polymer everolimus-based stent, built on the advanced platinum chromium platform, demonstrated low rates of revascularization while reporting no myocardial infarction or stent thrombosis at two years, and should offer physicians confidence and flexibility in treating longer lesions with a single stent."
The PLATINUM Long Lesion study met its primary endpoint of target lesion failure (TLF) at 12 months with a 3.2 percent rate for the PROMUS Element Stent in the per protocol population compared to a pre-specified performance goal of 19.4 percent (p<0.001) based on historical outcomes for the TAXUS Express Stent. The PROMUS Element Stent also demonstrated low event rates through two-year follow-up as evidenced by no myocardial infarction (MI or heart attack) and a 5.2 percent ischemia-driven target lesion revascularization (TLR) rate. There were no ARC definite/probable stent thrombosis events through two years.
"The PLATINUM Long Lesion two-year data build on the positive outcomes from the PLATINUM Workhorse, Small Vessel and QCA studies, confirming the successful transfer and favorable outcomes associated with everolimus to the novel platinum chromium thin-strut stent design," said Keith D. Dawkins, M.D., executive vice president and chief medical officer at Boston Scientific. "These results confirm an effective PtCr long lesion stent platform."
The PLATINUM Long Lesion trial compared the PROMUS Element Stent System in patients with long de novo lesions (>24 to </=34 mm in length and >/=2.50 to </=4.25 mm in diameter) to a pre-defined performance goal based on historical results in patients treated with the 32 mm TAXUS® Express™ Paclitaxel-Eluting Stent System. The prospective, single-arm trial enrolled 102 patients at 30 sites.
The PROMUS Element Stent System received CE Mark approval and was launched in Europe and other international markets in 2009. In November of 2011, Boston Scientific announced the launch of the System in the United States. The long lengths of PROMUS Element Plus were launched earlier this year. The PROMUS Element Stent features an innovative PtCr alloy and a stent design that offers greater radial strength, exceptional deliverability, and high fracture resistance and 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 increased radiopacity, facilitates precise placement of the stent across challenging lesions.
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: 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 clinical trials
and outcomes, product performance and impact, 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
214-546-5034 (cell)
Media Relations
Boston Scientific Corporation
steven.campanini@bsci.com
Michael Campbell
508-650-8023 (office)
Investor Relations
Boston Scientific Corporation
investor_relations@bsci.com
SOURCE Boston Scientific Corporation
Web Site: http://www.bostonscientific.com
Posted: October 2012
