Printer Friendly
The Free Library
14,581,586 articles and books
Member login
User name  
Password 
 
Join us Forgot password?

FDA APPROVES PROMUS EVEROLIMUS-ELUTING CORONARY STENT.


Boston Scientific Corporation (NYSE NYSE

See: New York Stock Exchange
:BSX BSX Bermuda Stock Exchange
BSX Bandai Satellaview-X
BSX Bicycle Super-X (Cross) 
), Natick, Mass. has announced that the U.S. Food and Drug Administration (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
) has approved the PROMUS(TM) Everolimus-Eluting Coronary Stent coronary stent Intracoronary stent Cardiology An expandable tubular device which can be inserted percutaneously, and left within a coronary artery lumen to maintain its patency Pros Clinical and angiographic outcomes are better with intracoronary artery stent  System for the treatment of coronary artery disease coronary artery disease, condition that results when the coronary arteries are narrowed or occluded, most commonly by atherosclerotic deposits of fibrous and fatty tissue. . The PROMUS Stent is a private-labeled XIENCE(TM) V Everolimus-Eluting Coronary Stent System manufactured by Abbott and distributed by Boston Scientific under an agreement executed prior to the 2006 acquisition of the former Guidant Corporation by Boston Scientific. FDA approval clears the way for Boston Scientific to launch the PROMUS Stent immediately in the U.S.

The PROMUS Stent expands Boston Scientific's drug-eluting stent (DES) portfolio, which includes the TAXUS(R) Express2(R) Paclitaxel-Eluting Coronary Stent System (in the U.S. and international markets) and the TAXUS(R) Liberte(R) Paclitaxel-Eluting Coronary Stent System (in international markets), making Boston Scientific the only company to offer physicians the choice of two distinct drugs (paclitaxel paclitaxel /pac·li·tax·el/ (pak?li-tak´sel) an antineoplastic that promotes and stabilizes polymerization of microtubules, isolated from the Pacific yew tree (Taxus brevifolia);  and everolimus) on separate DES platforms.

"The PROMUS Stent has shown outstanding deliverability, low late loss and the potential to reduce the need for re-interventions," said Ted Feldman, M.D., F.S.C.A.I., Director of the Cardiac Catheterization Cardiac Catheterization Definition

Cardiac catheterization (also called heart catheterization) is a diagnostic procedure which does a comprehensive examination of how the heart and its blood vessels function.
 Laboratory at Evanston Northwestern Healthcare Evanston Northwestern Healthcare, located in Chicago's northern suburbs, is an academic health system affiliated with the McGaw Medical Center of Northwestern University and all attending physicians are on faculty at the Feinberg School of Medicine.  in Evanston, Illinois. "These benefits will make the PROMUS Stent an attractive new treatment option for U.S. physicians and their patients."

"FDA approval of the PROMUS Stent fulfills Boston Scientific's promise of an unprecedented two-drug strategy - two distinct drugs on two highly deliverable stent platforms," said Jim Tobin, president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board.  of Boston Scientific. "The PROMUS Stent complements our broad DES portfolio and further reinforces Boston Scientific's leadership in the DES market, as well as our commitment to continued innovation and improved patient outcomes."

The next-generation PROMUS Stent is a highly deliverable stent made from cobalt chromium, which allows for thinner struts without sacrificing strength or visibility. The SPIRIT clinical trials indicate that the combination of the polymer/stent platform and the controlled release of the everolimus drug results in excellent deliverability, a strong safety profile, low levels of late loss and improved efficacy, making the PROMUS (XIENCE V) Stent a valuable addition to the U.S. drug-eluting stent market.

Boston Scientific's PROMUS Stent and Abbott's XIENCE V Stent are identical products sold by the respective companies under different brand names. The PROMUS (XIENCE V) Stent is indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to de novo [Latin, Anew.] A second time; afresh. A trial or a hearing that is ordered by an appellate court that has reviewed the record of a hearing in a lower court and sent the matter back to the original court for a new trial, as if it had not been previously heard nor decided.  native coronary artery coronary artery
n.
1. An artery with origin in the right aortic sinus; with distribution to the right side of the heart in the coronary sulcus, and with branches to the right atrium and ventricle, including the atrioventricular branches and
 lesions (up to 28 mm long) with reference vessel diameter of 2.5 to 4.0 mm.

As a result of agreements related to its acquisition of Guidant in 2006, Boston Scientific shares the rights to everolimus-eluting stent technologies with Abbott, including the XIENCE V Everolimus-Eluting Coronary Stent System (marketed by Boston Scientific as the PROMUS Stent). The company will continue to market its internally developed paclitaxel-eluting TAXUS Stent Systems, which have been the worldwide DES market leaders, implanted in more than four million people. Boston Scientific is also developing paclitaxel- eluting, everolimus-eluting and bare-metal versions of its third-generation Element(TM) Stent, which uses a unique platinum-enriched alloy.

The PROMUS Stent is currently for sale in Europe and certain other international markets. TAXUS and PROMUS are trademarks of Boston Scientific Corporation or its affiliates. XIENCE is a trademark of the Abbott Laboratories group of companies. SPIRIT is sponsored by Abbott. The TAXUS Liberte Paclitaxel-Eluting Coronary Stent System is pending approval by the FDA and is not available for sale in the United States.

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, visit http://www.bsci.com or call 508/650-8541.
COPYRIGHT 2008 Worldwide Videotex
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2008 Gale, Cengage Learning. All rights reserved.

 Reader Opinion

Title:

Comment:



 

Article Details
Printer friendly Cite/link Email Feedback
Publication:Biotech Equipment Update
Date:Aug 1, 2008
Words:608
Previous Article:FDA APPROVES ABBOTT'S XIENCE V DRUG ELUTING STENT.
Next Article:ALPHATEC SPINE INITIATES OSSEOFIX CLINICAL STUDY.
Topics:



Related Articles
FDA approves Cordis' Cypher stent for the treatment of coronary artery disease.(Brief Article)
FDA APPROVES BOSTON SCIENTIFIC LIBERTE CORONARY STEM.
CORDIS'S THIRD-GENERATION CORONORY STENT GETS CE MARK APPROVAL.
CORDIS PLANS MANUFACTURING FACILITY IN IRELAND.
FDA to update labeling for drug-eluting stents.(Medical Devices)
ABBOTT'S XIENCE CORONARY STENT SUPERIOR TO TAXUS.
FDA PANEL TO REVIEW MEDTRONIC'S ENDEAVOR DRUG ELUTING STENT.
BOSTON SCIENTIFIC ASSESSES OLIMUS-ELUTING STENTS REGISTRY.
ABBOT SUBMITS XIENCE V ELUTING STENT FOR APPROVAL IN JAPAN.
FDA APPROVES ABBOTT'S XIENCE V DRUG ELUTING STENT.

Terms of use | Copyright © 2009 Farlex, Inc. | Feedback | For webmasters | Submit articles