Navigation Links
Boston Scientific Begins Clinical Trial for Next-Generation Nitinol Stent to Treat Iliac Artery Disease

NATICK, Mass., May 20 /PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE: BSX) today announced the start of patient enrollment in the ORION clinical trial, which is designed to evaluate the Company's EPIC(TM) Self-Expanding Nitinol Stent System for the treatment of iliac artery disease, a form of peripheral artery disease that impacts a patient's lower extremities. The first U.S. patient was enrolled on May 14 by Nicolas W. Shammas, M.D., at Trinity Terrace Park Hospital in Bettendorf, Iowa.

"Peripheral stenting has become a recognized standard in the treatment of iliac arterial disease," said Daniel Clair, M.D., FACS, Principal Investigator of the trial and Chairman of the Department of Vascular Surgery, The Cleveland Clinic Foundation. "The ORION clinical trial will provide important data on the performance of the EPIC Stent in the treatment of atherosclerotic lesions in iliac arteries."

"We are encouraged by the early positive response to our EPIC Stent in Europe, where it was launched last month, and we are pleased to begin the process of evaluating it for use in the United States," said Donald S. Baim, M.D., Chief Medical and Scientific Officer of Boston Scientific. "The EPIC Stent is designed to offer a more balanced stent platform, allowing for excellent radial force without compromising stent flexibility and providing physicians a new option for treating iliac disease."

The EPIC Stent is a self-expanding nitinol stent designed to sustain vessel patency (openness), while providing enhanced visibility during placement. The ORION trial incorporates stent diameter ranges from 6-12 mm and lengths up to 120 mm. All stent sizes are compatible with 6F (2.1 mm) sheaths, and the stent delivery system is compatible with 0.035'' (0.89 mm) guidewires.

The trial will enroll 123 patients at 25 sites in the U.S. and will examine rates of device- and/or procedure-related major adverse events (MAE) at nine months. MAE are currently defined as death within 30 days, myocardial infarction (MI, or heart attack) occurring during related hospitalization, target vessel revascularization (TVR) through nine months and amputation of the treated limb through nine months.

The EPIC Stent is a next-generation product that builds on Boston Scientific's long-time leadership in the peripheral interventions market. The Company's peripheral product lines feature technologies used to diagnose and treat peripheral disease, including stents, balloon catheters, sheaths, wires, peripheral embolization solutions and vena cava filters. This advanced product portfolio offers physicians a range of peripheral stent indications, including the Carotid Wallstent(R) Endoprosthesis for carotid artery disease and the Express(R) SD Stent for renal artery disease.

The EPIC Nitinol Stent System is an investigational device and is limited by applicable law to investigational use only and is not available for sale in the U.S.

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:

Cautionary Statement Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of 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, regulatory approvals, competitive offerings and product performance. 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 thereafter. 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:  Paul Donovan
              508-650-8541 (office)
              508-667-5165 (mobile)
              Media Relations
              Boston Scientific Corporation

              Larry Neumann
              508-650-8696 (office)
              Investor Relations
              Boston Scientific Corporation

SOURCE Boston Scientific Corporation
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Boston Scientific Launches Third-Generation Platinum Chromium Drug-Eluting Stent
2. Boston Scientific Data Show Real-World Survival Rates for Implantable Cardiac Device Patients Exceed Rates From Clinical Trials
3. Journal of American College of Cardiology Article Reports Fewer Repeat Procedures With Boston Scientifics TAXUS(R) Liberte(R) Stent
4. Boston Scientific Welcomes Publication of HORIZONS AMI Trial Results in New England Journal of Medicine
5. Clinical Data Reinforce Safety and Efficacy of Boston Scientifics Two Drug- Eluting Stent Platforms
6. New England Journal of Medicine Publishes Results from Boston Scientifics Landmark SYNTAX(TM) Trial
7. Boston Scientific Submits Final Modules to FDA for Approval of Second-Generation Small Vessel and Long Lesion Stents
8. Boston Scientific Begins Clinical Trial Enrollment for New Everolimus-Eluting Stent
9. Taxus Atlas Studies Reinforce Safety and Efficacy of Boston Scientifics Next-Generation Taxus Liberte Stent
10. Boston Scientific to Release Broad Range of Clinical Trial Data on the Performance of TAXUS(R) Coronary Stent Systems at TCT 2008
11. Boston Scientific Completes Clinical Trial Enrollment for Third-Generation Drug-Eluting Stent
Post Your Comments:
(Date:11/26/2015)... , November 26, 2015 /PRNewswire/ ... announced the addition of the  "2016 ... the European Therapeutic Drug Monitoring (TDM) ... Competitive Intelligence, Emerging Opportunities"  report to ... ) has announced the addition of ...
(Date:11/26/2015)... 26, 2015 Research and Markets ( ... "2016 Future Horizons and Growth Strategies in ... Shares, Country Segment Forecasts, Competitive Intelligence, Emerging Opportunities" ... --> --> This new ... Italian therapeutic drug monitoring market, including emerging tests, ...
(Date:11/25/2015)... 2015 ... "Global Brain Monitoring Devices Market 2015-2019" ... ) has announced the addition ... Market 2015-2019" report to their offering. ... ) has announced the addition of ...
Breaking Medicine Technology:
(Date:11/26/2015)... ... November 26, 2015 , ... Indosoft Inc., developer and distributor of the ... to improve system efficiency and reliability. , The new Q-Suite 6 platform is based ... system avoids locking itself into a specific piece of software for many key components ...
(Date:11/25/2015)... ... November 25, 2015 , ... Medical Solutions, one of the ... stellar workplace culture with the company’s Cincinnati office being named a finalist among ... was named a finalist in Cincinnati Business Courier’s 13th annual Greater Cincinnati Best ...
(Date:11/25/2015)... ... November 25, 2015 , ... For the first time, Vitalalert is donating ... Beat ” campaign. The partnership between the two groups began in 2014 with Vitalalert ... cause. , MAP International was founded in 1954 and is an international Christian-based health ...
(Date:11/25/2015)... ... November 25, 2015 , ... Wimbledon Health ... launches new Wimbledon Athletics Facebook page to educate the public, parents ... cardiac abnormalities. About 2,000 people under the age of 25 die from sudden ...
(Date:11/25/2015)... ... November 25, 2015 , ... Beddit® has launched a ... tracking systems. The new app features a more intuitive SleepScore™ that rates sleep quality ... you slept. The SleepScore is created by a proprietary algorithm. Beddit analyzes the data ...
Breaking Medicine News(10 mins):