The demonstration at the RSA security conference in San Francisco was a genuine attention-getter. A program launched by the push of a computer key breeched the security credentials of an infusion pump strapped to an onstage “diabetic” mannequin and instructed the device to dump what would be a lethal insulin dose into the dummy s “bloodstream.”
Federal health officials are asking safety questions about the first artificial heart valve designed to be implanted without major surgery, ahead of a meeting this week to consider broadening its use. Last summer Edwards Lifesciences Corp. won approval for its first-of-a-kind Sapien heart valve, which can be threaded into place through one of the body’s major arteries. The valve is currently available for patients who aren’t healthy enough to undergo the more invasive open-heart surgery which has been used to replace the valve for decades.
The incidence of infective endocarditis among dental patients in Olmsted County, Minn. did not increase after new guidelines called for giving preventive antibiotics before dental procedures only to those at greatest risk of complications, according to independent research published in Circulation, an American Heart Association journal.
FDA reviewers said Monday that the Sapien Transcatheter Heart Valve met study endpoints for safety and effectiveness as an option for high-risk patients with severe aortic stenosis, but raised concerns about an increased risk for stroke. The valve, made by Edwards Lifesciences, will be reviewed on Wednesday by the FDA s Circulatory Systems Advisory Committee, which will consider whether the device should be used in "high-risk" patients -- those who are candidates for aortic valve replacement but who have an open-heart surgery mortality risk of 15% or more.
A recent paper, published online before print in SCAI s journal, Catheterization and Cardiovascular Interventions, yet again adds to the evidence that intravascular ultrasound (IVUS) imaging during PCI can improve stent placement and expansion in a way that may prevent stent thrombosis (ST).
The U.S. Food and Drug Administration (FDA) has provided Boston Scientific Corporation (NYSE: BSX) regulatory approval of 32 mm and 38 mm lengths for the PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System, the company s next-generation drug-eluting stent (DES) technology. The PROMUS Element Stent is built on an innovative platinum chromium (PtCr) platform with the market-leading everolimus drug and is designed to provide physicians exceptional DES performance in treating patients with coronary artery disease. The 32 and 38 mm lengths of the PROMUS Element Plus Stent System are immediately available in the U.S.
Abbott (NYSE: ABT) was once again named one of the "Best Places to Work in Industry" by The Scientist magazine. Abbott ranked No. 14 on the 2012 list. This is the ninth time that Abbott has been on the list since The Scientist first started ranking companies in 2003.
Having a coordinated, statewide system for treating patients with ST-segment elevation myocardial infarction (STEMI) appears to improve rapid access to reperfusion, a study in North Carolina showed. Expanding a regional system to the entire state was associated with improved treatment times, particularly among patients who required interhospital transfer, according to James Jollis, MD, of the Duke Clinical Research Institute, and colleagues.
A risk score derived from variables that are routinely gathered in the emergency department may help guide the decision to admit or discharge patients presenting with acute heart failure, researchers found. The 10-factor algorithm showed a high level of discrimination in predicting the likelihood of patients dying within 7 days of presentation in both a derivation and validation cohort, according to Douglas Lee, MD, PhD, of the Institute for Clinical Evaluative Sciences in Toronto, and colleagues.
Un equipo de Japón y Holanda asegura que un estudio durante más de 10 años prueba la seguridad del primer stent coronario completamente biodegradable fabricado con ácido poli l-láctico (PLLA). "Nuestro estudio garantiza con solvencia el uso futuro de los stent liberadores de fármacos (DES, por su nombre en inglés) biodegradables", dijo el doctor Kunihiko Kosuga.
This is a brief overview of information related to FDA s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA s approval.
In patients with non-ST segment elevation acute coronary syndromes (ACS), outcomes of percutaneous coronary intervention were worse with incomplete revascularization than complete, researchers found. The 1-year rate of major adverse cardiac events was 23.4% for those with incomplete revascularization and 16.6% for those with complete revascularization (P<0.0001), according to Gregg Stone, MD, of Columbia University in New York City, and colleagues.
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