FDA Advisory Panel Unanimously Recommends Approval of Guidant's ANCURE System for Minimally Invasive Treatment of Abdominal Aortic Aneurysms.INDIANAPOLIS--(BW HealthWire)--June 23, 1999-- Guidant Corporation (NYSE NYSE See: New York Stock Exchange :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 ) and (PCX (1) A bitmapped graphics file format that handles monochrome, 2-bit, 4-bit, 8-bit and 24-bit color and uses RLE to achieve compression ratios of approximately 1.1:1 to 1.5:1. Images with large blocks of solid colors compress best under the RLE method. See PC Paintbrush. :GDT), a global leader in cardiovascular and vascular therapy, announced today that the Circulatory System circulatory system, group of organs that transport blood and the substances it carries to and from all parts of the body. The circulatory system can be considered as composed of two parts: the systemic circulation, which serves the body as a whole except for the Devices Panel of the Medical Devices Advisory Committee has unanimously recommended 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. approval with conditions of its ANCURE(TM) System for minimally invasive treatment of abdominal aortic aneurysms abdominal aortic aneurysm A focal aortic dilation of ≥ 50% ↑ in diameter, accompanied by distension and weakened aortic wall Epidemiology Incidence is rising 12/105–1951; 36/105 (AAA AAA: see American Automobile Association. (Triple A) A common single-cell battery used in a myriad of electronic devices of all variety. Like its double A (AA) cousin, it provides 1.5 volts of DC power. When used in series, the voltage is multiplied. ). The FDA will now consider the Panel's recommendation and conditions, together with additional information to be provided by the company, prior to making its final decision. AAA is an enlargement of the aorta, the main artery of the human body, resulting from a weakness of the vessel wall. If untreated, this enlargement can lead to aortic aortic pertaining to or emanating from the aorta. See also aortic arch. aortic aneurysm occurs most often in dogs, where it is caused by Spirocerca lupi larvae, turkeys and primates, causing dyspnea, cyanosis and coughing. rupture, which in nearly 80 percent of cases, results in the death of the patient. It is believed that 1.5 million people in the United States have AAA, with most cases being undiagnosed. Each year, 190,000 new cases of AAA are diagnosed, resulting in major surgery for approximately 45,000 of these patients. The 15,000 deaths attributed to AAA each year make it the nation's thirteenth-leading cause of death. Minimally invasive treatment of AAA represents a potentially significant clinical advance over the traditional surgical procedure. Guidant's data, presented to the Panel today, showed that patients implanted with the ANCURE(TM) System experienced significantly fewer complications than those who underwent conventional surgery. The data also showed that with Guidant's endovascular approach a patient's length of hospital stay is reduced to two to three days, versus six days with traditional surgery. "We are pleased by the Panel's decision to recommend approval of Guidant's ANCURE(TM) System," said Jay Watkins, president of Guidant's Cardiac & Vascular Surgery Group. "Today's vote is a significant milestone, which moves us closer to our ultimate goal of providing these patients with a minimally invasive alternative to conventional AAA surgery." "The Panel's recommendation to the FDA for approval of Guidant's ANCURE(TM) System marks a significant step in our mission of building a position of unquestioned leadership in cardiovascular and vascular medicine," said Ron Dollens, president and chief executive officer of Guidant Corporation. A global leader in the medical device industry, Guidant provides innovative, minimally invasive and cost-effective products and services for the treatment of cardiovascular and vascular disease. For more information about Guidant's products and services, visit the company's Web site at http://www.guidant.com. |
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