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After more than two years of questions raised by clinical data concerning the safety and efficacy of drug-eluting stents (DES), declines in the sales of DES devices because of these questions, and DES developers looking for R&D and regulatory guidance, FDA last month issued a new set of guidelines, in draft form, concerning the development, testing and manufacture of DES devices.
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The implantable cardiac defibrillator (ICD) market may be poised to rebound from the black eye it has suffered following recalls and recent lead malfunctions, based on news from the REsynchronization reVErses Remodeling in Systolic left vEntricular dysfunction (REVERSE) trial - intended to establish that patients with mild heart failure may benefit from cardiac resynchronization therapy (CRT).
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Charles Maroney has been president/CEO, since February 2006, of CardioMind (Sunnyvale, California), a development-stage company focused on a small-diameter stent delivery platform with applications in treating coronary, neuro and peripheral artery disease. This is currently a $5 billion-plus worldwide market.
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Results from a six-month economic analysis comparing the cost of off-pump, "beating heart" coronary artery bypass graft (CABG) procedures with the cost of traditional on-pump CABG surgery showed that beating-heart CABG saved $1,684 per procedure compared to traditional bypass surgery.
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eResearchTechnology; nSpire Health, Advanced Cell Technology; Chandler Regional Medical Center; Mercy Gilbert Medical Center; Catholic Healthcare West; Alliant Healthcare Products; Premier Purchasing Partners; Angiotech Pharmaceuticals; Rex Medical; Cardiac Science; Misys Healthcare; Cardinal Health; GE Healthcare; Global Research Services; CardioDynamics; Piedmont Heart Institute; Cardiology of Georgia; Piedmont Healthcare
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Trauma in wartime is especially high risk given the nature of the injuries, the high risk of infection, and the limited access to optimal medical care.
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In 1985, the newly fda-approved antimicrobial agent, Primaxin® (imipenem/cilastatin), introduced a new class of drugs known as carbapenems. This new class provided benefits as well as unwanted side effects. Carbapenems work similarly to other â-lactam antibiotics, but with substantially broader-spectrum of activity and better penetration into bacterial cell walls to prevent synthesis.
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Eight hiv-infected patients (mean CD4+ t cell count 622 cells/uL) who had been receiving effective HAART for an average of 8.4 years were included in this study. PBMCs were obtained by leukapheresis and endoscopic terminal ileum biopsies were performed to obtain samples of Gut-Associated Lymphoid Tissue (GALT).
