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In a nearly unanimous vote, an FDA panel voted last month to oppose new labeling sought by WorldHeart (Ottawa, Ontario) for its Novacor LVAS (left ventricular assist system) for use with very sick heart-failure patients. The panel said WorldHeart did not present enough evidence to show the device would let those sicker patients improve enough to receive a heart transplant.
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Cardiocom (Minneapolis, Minnesota) reported that Ucare Minnesota, a non-profit health maintenance organization, renewed its multi-year agreement with the disease management company to provide systems for remote daily home monitoring of Ucares congestive heart failure (CHF) patients.
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A bipartisan group of lawmakers introduced legislation last month to change Medicare to cover ultrasound screening for abdominal aortic aneurysm (AAA), often called a silent killer. At a Capitol Hill press conference, Sens. Christopher Dodd (D-Connecticut) and Jim Bunning (R-Kentucky) and Rep. Gene Green (D-Texas) joined members of the National Aneurysm Alliance (Washington) and aortic aneurysm survivors to announce the SAAAVE (Screening Abdominal Aortic Aneurysm Efficiently) Act.
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Conor Medsystems (Menlo Park, California) presented acute and follow-up data from the PISCES (Paclitaxel In-Stent Controlled Elution Study) trial during last months EuroPCR (previously Paris Course on Revascularization) conference in Paris. The company said results from the trial support the safety of its stents and demonstrated in one of the study arms a binary restenosis rate of 0%.
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In an agreement that appears to bolster the growing trend toward medical device/biotechnology combination products, device giant Medtronic (Minneapolis, Minnesota) and Genzyme (Cambridge, Massachusetts), a large biotech company that focuses on rare genetic diseases as well as other disorders, have formed a joint venture to accelerate the development of new treatments for some of the most intractable forms of cardiovascular disease.
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Angeion (St. Paul, Minnesota) said Richard Jahnke, president and chief executive officer of Angeion and its Medical Graphics subsidiary, plans to retire at the end of the fiscal year on Oct. 31. Jahnke became CEO of Medical Graphics in August 1998 and CEO of Angeion in January 2000 after Angeion acquired Medical Graphics the previous month. The board of directors has selected Rodney Young to succeed Jahnke. Young was most recently president and CEO of LecTec.
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As part of its ongoing association studies in several cardiovascular indications, Celera Diagnostics (Alameda, California) has presented data linking genetic variations in two genes with increased risk for myocardial infarction (MI), commonly known as heart attack.
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The main reasons Susan Baxley, corporate admitting manager, wanted to work for Adventist Health were because of its mission statement to share Gods love by providing physical, mental, and spiritual healing, and because of its desire to implement best practice registration.