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CircuLite Inc. announced that it has received CE marking approval for the Synergy Circulatory Support System, a micro-pump designed to halt the progression of heart failure. By working with the heart’s native pumping capacity, Synergy is specifically targeted for treatment of ambulatory heart failure patients (INTERMACS 4,5,6 / NYHA IIIB and early IV) who remain symptomatic despite standard medical management.

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Technology

Abiomed Inc. announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a new percutaneous, catheter-based Impella ventricular assist device (VAD) providing peak flows of approximately 4 liters of blood per minute. The increased flow is delivered on the same console platform, 9 French catheter and introducer as the Impella 2.5. This new heart pump will be marketed as the Impella CP (Cardiac Power) within the United States and has been commercially known outside the U.S. as the Impella cVAD.

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September 11, 2012 β€” St. Jude Medical Inc. announced the realignment of its product divisions into two new operating units: the Implantable Electronic Systems Division (IESD) and the Cardiovascular and Ablation Technologies Division (CATD).

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The Abiomed Impella heart pump
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September 11, 2012 β€” Primary results from an ongoing trial by Maquet Cardiovascular using intra-aortic balloon pumps (IABP) as an adjuvant treatment for myocardial infarction (MI) complicated by cardiogenic shock have shown no difference in patient survival when compared to standard care alone.

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September 11, 2012 β€” Since the previous consensus document was published in 2007, catheter and surgical ablation of atrial fibrilliation (AF) have become standard treatments and more randomized trials of ablation versus optimal drug therapy for AF have been conducted. β€œSignificantly more data exist on techniques, success rates and complications of these new interventions, making this a more valid document compared to 2007,” said Professor Karl Heinz Kuck of Germany, president-elect of the European Heart Rhythm Association (EHRA) and co-chair of the task force that developed the latest document.

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September 11, 2012 β€” Data presented at the 2012 ESC Congress in Munich from the prospective DeFACTO study show that, when compared to standard coronary angiography, the noninvasive assessment of fractional flow reserve by computed tomography (FFR-CT) provides a more accurate determination of which lesions require invasive evaluation.

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News | Cardiogenic Shock

September 10, 2012 β€” Maquet Cardiovascular LLC announced 30-day results from the large, randomized, multicenter intra-aortic balloon pump (IABP)-SHOCK II clinical trial in patients with acute myocardial infarction (AMI) who were in cardiogenic shock and undergoing early revascularization. The findings showed that use of intra-aortic balloon counter-pulsation (IABC) therapy was associated with an observed improvement in all-cause mortality at 30 days, but the trial did not meet the pre-specified 12 percent improvement in survival endpoint compared with standard medical therapy.

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Technology

September 10, 2012 β€” TeraRecon announced the launch of iNtuition Review, iNtuition Enterprise Medical Viewer (iEMV) and iNtuition Share. The software suite enhances the iNtuition portfolio with multimodality review solutions for advanced imaging, such as cardiac and breast procedures, with enterprise distribution and image sharing capability.

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September 10, 2012 β€” In a recent study, researchers found that coffee consumption is inversely related to mortality, with consumption of greater than or equal to six cups of coffee per day associated with a 10 percent decreased mortality rate in men and 15 percent decreased mortality in women.

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September 10, 2012 β€” In a recent clinical trial, the Solitaire Flow Restoration Device dramatically outperformed the standard mechanical treatment. Findings from the trial, called SOLITAIRE With the Intention for Thrombectomy (SWIFT), are published online in The Lancet and will also appear in a later print edition of the journal.

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September 10, 2012 β€” Atrial fibrillation (AF) is a common complication of cardiac surgery, occurring in 10 to 40 percent of patients. Recent studies show it to be associated with poorer health following surgery and poorer long-term survival. Furthermore, development of AF after cardiac surgery leads to average additional healthcare costs of $15,000 to $20,000.

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September 7, 2012 β€” The American Medical Association (AMA) recently sent letters to Sen. Ben Cardin of Maryland and Rep. Pete Olson of Texas supporting passage of the Diagnostic Imaging Services Access Protection Act (H.R. 3269/S. 2347).

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Feature | Dave Fornell

There has been much debate whether computer-aided detection software for computed tomography (CT) scanners to detect coronary blockages is really a worthwhile expense. There has long been apprehension by experienced cardiologists and radiologists who can easily read coronary CT angiography (CCTA) scans for plaque burden. However, the technology may have a niche application for immediate STAT reads of chest pain patients during off-hours, especially at rural medical centers.

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September 7, 2012 β€” St. Jude Medical Inc. announced results of the FAME II trial demonstrating that patients with fractional flow reserve (FFR)-guided stenting plus the best available medical therapy (MT) had superior outcomes to those treated with MT alone.

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September 6, 2012 β€” Drug-eluting stents (DES) are used less often in women treated with percutaneous coronary intervention (PCI) for coronary artery disease (CAD) than men treated with PCI for the same condition, according to research presented at the European Society of Cardiology (ESC) Congress 2012. The findings from a countrywide Germany registry were presented by Dr. Martin Russ.

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