Angiotech partner first to receive FDA approval allowing immediate MRI exams for its TAXUS(R) Express(2)(TM) paclitaxel-eluting stent system; Typical two-month wait eliminated for patients with Boston Scientific stent systems.VANCOUVER, April 5 /PRNewswire-FirstCall/ -- Angiotech Pharmaceuticals, Inc. corporate partner Boston Scientific Corporation ("Boston") today announced that the U.S. Food and Drug Administration (FDA) has approved enhancements to the Directions for Use (DFU DFU Directions For Use
DFU Device Firmware Upgrade (or Update)
DFU Dansk Folkepartis Ungdom (Youth of the Danish People's Party)
DFU Danmarks Fiskeriundersøgelser
DFU Data File Utility ) of the TAXUS(R) Express(2)(TM) paclitaxel-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, indicating that patients receiving the stent systems may safely undergo Magnetic Resonance Imaging magnetic resonance imaging (MRI), noninvasive diagnostic technique that uses nuclear magnetic resonance to produce cross-sectional images of organs and other internal body structures. (MRI 1. (application) MRI - Magnetic Resonance Imaging.
2. MRI - Measurement Requirements and Interface. ) examination immediately following implantation. The TAXUS stent system is the first drug-eluting stent to receive approval for immediate post-procedure MRI. Boston Scientific's Express(2) (bare-metal) stent system also received approval for immediate MRI exams. Patients receiving coronary stents have typically been required to wait approximately two months before receiving an MRI.
MRI is an effective method of providing detailed diagnosis for many types of injuries and conditions, including cardiovascular disease. Due to the use of intense magnetic fields in MRI examinations, implanted medical devices that contain metal may be subject to potential migration and heating within the body. As a result, DFUs for stent systems containing metal usually recommend a waiting period of approximately two months from the time of implantation until an MRI can be performed safely.
Boston Scientific performed rigorous laboratory testing to demonstrate MRI compatibility. The TAXUS Express(2) and Express(2) systems were shown to be MRI safe at a high level of magnetic field strengths with minimal effect on temperature rise and drug release.
"The FDA approval of the timing on MRI exams is a significant development for interventional cardiologists and their patients," said Paul LaViolette, Boston Scientific Chief Operating Officer Chief Operating Officer (COO)
The officer of a firm responsible for day-to-day management, usually the president or an executive vice-president. . "Patients undergoing stent procedures can now avoid the long waiting period previously required before receiving MRI diagnostics during the most critical stage of their recovery. With our stent systems, MRI analyses can now be performed immediately." Physicians interested in reviewing a complete copy of the revised TAXUS Express(2) stent DFU may obtain a copy from the TAXUS website at http://www.taxus-stent.com/. The revised Express(2) bare-metal stent DFU will be available shortly.
BSC (Binary Synchronous Communications) See bisync. acquired worldwide exclusive rights from Angiotech to use 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); to coat its coronary stent products and has co-exclusive rights to other vascular and non-vascular products.
Vancouver-based Angiotech Pharmaceuticals, Inc. is a specialty pharmaceutical company pioneering the combination of pharmaceutical compounds with medical devices and biomaterials to both create novel solutions for poorly addressed disease states and dramatically improve surgical outcomes. To find out more about Angiotech Pharmaceuticals, Inc. , please visit our website at http://www.angiotech.com/.
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CONTACTS: Todd Young, Angiotech Pharmaceuticals, Inc. (Analysts & Investors) (604) 221-7676 ext 6933 Rui Avelar, Angiotech Pharmaceuticals, Inc. (Analysts) (604) 221-7676 ext 6996 Eric Starkman, Starkman & Associates (Media) (212) 252-8545 ext 12
CONTACT: Todd Young, Angiotech Pharmaceuticals, Inc. (Analysts & Investors), (604) 221-7676 ext 6933; Rui Avelar, Angiotech Pharmaceuticals, Inc. (Analysts), (604) 221-7676 ext 6996; Eric Starkman, Starkman & Associates (Media), (212) 252-8545 ext 12