Boston Scientific Begins Clinical Check For Next-Generation Nitinol Stent To Treat Iliac Artery Disease
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Boston Scientific Corporation (NYSE: BSX) announced the derivation of patient enrollment in the ORION clinical trial, which is designed to evaluate the Company's EPIC(TM) Self-Expanding Nitinol Stent Action for the treatment of iliac artery disease, a design of peripheral artery disease that impacts a patient's lower extremities. The head 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 be remodelled a recognized principles in the treatment of iliac arterial disease," said Daniel Clair, M.D., FACS, Principal Investigator of the test and Chairman of the Department of Vascular Surgery, The Cleveland Clinic Foundation. "The ORION clinical trial will bring relevant info 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 satisfied to begin the growth of evaluating it for convenience in the United States," said Donald S. Baim, M.D., Manager Medical and Scientific Officer of Boston Scientific. "The Legend Stent is designed to rendition a expanded balanced stent platform, allowing for excellent radial coercion without compromising stent flexibility and providing physicians a dissimilar preference 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 research incorporates stent thickness 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 evaluation will enrol 123 patients at 25 sites in the U.S. and will examine rates of device- and/or procedure-related extensive 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, body vessel revascularization (TVR) wrapped up nine months and amputation of the treated limb fini 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 event technologies used to diagnose and treat peripheral disease, including stents, balloon catheters, sheaths, wires, peripheral embolization solutions and vena cava filters. This modern product portfolio offers physicians a radius 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 slogan and is regional by relevant regulation to investigational use peerless 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 wide span of interventional medical specialties.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements within the impression of Section 21E of the Securities Convert 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 break available to us at the time and are not intended to be guarantees of likely events or performance. These forward-looking statements include, among other things, statements regarding clinical trials, regulatory approvals, competitive offerings and product performance. Whether our underlying assumptions turn out to be incorrect, or provided sure 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 ultimate (together with other factors) could influence our ability to implement our livelihood 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 habitat undue reliance on any of our forward-looking statements.
Factors that may agency such differences include, among other things: imminent economic, competitive, reimbursement and regulatory conditions; new product introductions; demographic trends; highbrow property; litigation; financial market conditions; and, future affair decisions fabricated by us and our competitors. All of these factors are laborious or impossible to predict accurately and many of them are beyond our control. For a too list and discription of these and other exigent risks and uncertainties that may affect our eventual operations, see Division I, Item 1A - Risk Factors in our most recent Annual Announcement on Conformation 10-K filed with the Securities and Change Commission, which we may refresh in Part II, Reason 1A - Risk Factors in Quarterly Reports on Form 10-Q we bear filed or testament record thereafter. We disclaim any basis or obligation to publicly revise or revise any forward-looking statements to catch any change in our expectations or in events, conditions, or circumstances on which those expectations may be based, or that may move 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.
Source: Boston Scientific Company
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