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May 9, 2012 — Sound Interventions Inc. announced the successful completion of the company's first-in-human clinical trial to treat resistant hypertension, SOUND-ITV.

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May 9, 2012 — Boston Scientific Corp. announced U.S. Food and Drug Administration (FDA) approval and market launch of its Ingenio and Advantio pacemakers and Invive cardiac resynchronization therapy pacemakers (CRT-P).

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May 9, 2012 – The College of Healthcare Information Management Executives (CHIME) submitted its comments on the proposed rules for Stage 2 Meaningful Use (MU), calling for more time to allow healthcare organizations to better prepare.

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Fetal interventional heart procedure_Access and imaging on mom_from Texas Children's Hospital PR
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May 8, 2012 – The team at Texas Children's Fetal Center has successfully completed two in-utero fetal cardiac interventions to treat hypoplastic left heart syndrome (HLHS), a congenital heart defect that is one of the most complex heart defects to treat.

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May 7, 2012 — Wide Beam Reconstruction (WBR) reduces the required radiopharmaceutical dose and image acquisition time by 50 percent for diagnostic quality myocardial perfusion imaging (MPI) single photon emission computed tomography (SPECT), according to a new study published in the March/April 2011 issue of the Journal of Nuclear Cardiology.

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May 7, 2012 - On May 4, the American College of Radiology (ACR) submitted comments to the Centers for Medicare and Medicaid Services (CMS) and the Office of the National Coordinator for HIT (ONC) regarding the agencies' March 7, 2012, proposed rules to revise and update the professional and technology requirements of the EHR Incentive Program (“meaningful use”). The ACR IT and Informatics Committee (ITIC) - Government Relations Subcommittee compiled the comments with feedback from ACR members, allied organizations and other stakeholders.

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May 4, 2012 - CardioDex announces initial commercial use of a new femoral access site closure device. Recent data from commercial use of the device on 41 patients at St. Marien Hospital in Siegen, Germany showed 100% success rate and no complications.

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May 4, 2012 - Edwards Lifesciences Corp. announced that new data from the European multi-center Triton trial studying the Edwards Intuity valve system highlights the promise of several important benefits, including the facilitation of small-incision surgery for aortic valve replacement (AVR), a high procedural success rate, and consistent and sustained hemodynamic valve performance at one year. The data were presented today during the Emerging Technologies and Techniques Forum at the American Association for Thoracic Surgery's 92nd annual meeting in San Francisco.

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May 4, 2012 - Angioslide Ltd., a provider of embolic capture angioplasty solutions, announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its new 3x100 mm Proteus device for treating peripheral artery disease in below-the-knee (BTK) vasculature. The new 3/100 mm device accommodates 0.014-inch guidewires, which significantly broaden the potential use of Proteus technology.

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May 4, 2012 - A new balloon catheter system could advance the endovascular approach to treating obstructed arteries in the leg, offering an alternative to surgical revascularization. Peripheral artery disease affects about 12 to 14 percent of the general population. Revascularization can be achieved through bypass surgery or a number of minimally invasive endovascular techniques that seek to reduce or eliminate symptoms of reduced blood flow by improving tissue perfusion. Chronic total occlusions of the superficial femoral artery and popliteal artery, some of the most difficult lesions to recanalize with conventional guidewire techniques, were treated with this new system.

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May 4, 2012 - An advanced, comprehensive cardiac monitoring system – PocketECG – combines and builds on the best features available from traditional Holter, event and mobile telemetry monitoring. Unlike other monitoring systems on the market, the recently introduced Spectocor PocketECG analyzes and then streams full-disclosure rhythm data to a monitoring center on a continuous basis.

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May 4, 2012 - SMT Research & Development Ltd. (SMT) announced the addition of three key executives to its management team, including a new CEO, CFO and chief medical officer, plus two additions to its board of directors. The company also announced that its shareholders and board of directors have approved the company's name change to Keystone Heart Ltd.

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May 4, 2012 - The U.S. Food and Drug Administration (FDA) has approved the premarket approval application (PMA) for the Medinol Ltd. Presillion plus cobalt chromium (CoCr) coronary stent on a rapid exchange delivery system. This device is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease associated with stenotic lesions in de novo native coronary arteries (length < 30 mm) with a reference vessel diameter of 2.5 to 4 mm.

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May 4, 2012 - Medtronic Inc. announced six-month pooled outcomes from randomized and crossover patients in the Symplicity HTN-2 clinical trial following renal denervation with the Symplicity renal denervation system showing significant, sustained blood pressure reduction in patients with treatment-resistant hypertension. These data presented at the European Society of Hypertension annual meeting showed patients (n=84) who received renal denervation treatment with Symplicity experienced a mean blood pressure reduction of -28/-10 mm Hg (p<0.001) at six months following treatment compared with baseline. No evidence of renal impairment was observed and renal function measures remained unchanged.

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May 2, 2012 — The Spectranetics Corp. announced U.S. Food and Drug Administration (FDA) approval of the new advanced GlideLight Laser Sheath for removal of cardiac leads.

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