Guidant announces IDE approval to clinically evaluate its RX Stent Delivery System.INDIANAPOLIS--(HealthWire)--Dec. 16, 1996--Guidant Corporation (NYSE NYSE See: New York Stock Exchange and PSE PSE 1. pale soft exudative pork. 2. portosystemic encephalopathy. : GDT GDT Global Descriptor Table GDT Geographic Data Technology Inc. GDT Gas Discharge Tube (energy, electrotechinical and electronics) GDT Getting Things Done GDT Geometric Dimensioning & Tolerancing GDT Ground Data Terminal ), a worldwide leader in vascular intervention, today reported that it has received Investigational Device Exemption An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and (IDE) approval from the Food and Drug Administration to clinically evaluate its ACS (Asynchronous Communications Server) See network access server. RX MULTI-LINK(TM) Coronary Stent System in the U.S. Clinical evaluation for Guidant's new rapid exchange (RX) low-profile, sheathless system will begin immediately. "The RX platform is designed to provide the physician operator with the ability to exchange technology in a rapid fashion, which is often required during stent procedures," Ginger Howard, president of Guidant's Vascular Intervention group, explained. "The benefits of rapid exchange capability have been demonstrated, including less fluoroscopy fluoroscopy /flu·o·ros·co·py/ (fldbobr-ros´kah-pe) examination by means of the fluoroscope. fluo·ros·co·py n. Examination by means of a fluoroscope. Also called radioscopy. time, better cost management and ease of technology exchange by a single physician." The ACS RX MULTI-LINK Coronary Stent Delivery System was evaluated and market released in Europe during 1996. The ACS MULTI-LINK Stent is designed for optimal radial strength, and features multiple linked rings for flexibility and conformity. It is an expandable stent that has been mounted on an RX delivery system that incorporates a low-profile, low-compliant PE-600(R) balloon. The RX delivery system utilizes distinct markers to position and deploy the stent. Stents are metal tubes or coils that are mounted on a dilatation catheter, which is inflated to expand the stent in the artery. When the catheter is removed from the artery, the stent stays in place, which provides a "mechanical" way of keeping the artery open. A leader in the medical device industry, Guidant Corporation provides innovative, cost-effective products and services to the global cardiology and minimally invasive surgery minimally invasive surgery Laparoscopic surgery, see there. See Laparoscopic cholecystectomy. marketplaces. CONTACT: Guidant Corporation, Indianapolis Robert Allen, Media Relations, 317/971-2031 Todd McKinney, Investor Relations, 317/971-2094 |
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