News

February 5, 2010 – European CE mark approval was granted and first implants reported for the Fortify and Fortify ST implantable cardioverter defibrillators (ICD) and Unify cardiac resynchronization therapy defibrillator (CRT-D). The reduced size of these new devices compared to those of previous generations creates one of the smallest available device footprints in the industry.

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February 5, 2010 – A new, large-scale pivotal phase III trial has been initiated for edoxaban to evaluate its safety and efficacy in reducing recurrent venous thromboembolic (VTE) complications in patients with deep-vein thrombosis (DVT) and/or pulmonary embolism (PE).

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February 5, 2010 – Enrollment is complete for the trial of a polymer-based gel that rapidly transitions to a solid at body temperature, forming a plug that can temporarily occlude blood vessels for heart surgery.

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“Information is the lifeblood of modern medicine. Health information technology is destined to be its circulatory system.”(1) When Dr. David Blumenthal’s words appeared in the New England Journal of Medicine(2) last month, he was referring to the IT infrastructure the Department of Health and Human Services is building across the United States.

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February 5, 2010 – Cardiac surgical ablation system maker AtriCure agreed to pay $3.8 million plus interest for allegedly using illegal kickbacks and an off-label marketing campaign to induce physicians and hospitals to perform its costly inpatient cardiac surgical ablation procedures over less expensive outpatient catheter ablation procedures.

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Technology

February 4, 2010 – The FDA granted market clearance today for Toshiba America Medical Systems Inc.’s Viamo laptop ultrasound system. The device offers the same capabilities as larger cart-based systems that were previously unavailable on hand-carried systems. The Viamo was introduced at the 2009 Radiological Society of North America (RSNA) annual meeting.

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Case Study

For more than a decade, Barry T. Katzen, M.D., medical director of Baptist Cardiac and Vascular Institute (BCVI) in Miami, Fla., has pioneered the integration of surgical and interventional procedures. Dr. Katzen and his team continue to show that surgical procedures in an angiographic environment can be accomplished with the same degree of efficiency as in an operating room (OR).

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Feature

In the past five years, no sector of healthcare has had as big a target on its back as advanced diagnostic imaging services has. Representatives of commercial insurance companies, politicians and even the media all have gravitated to using an MRI or CT service as the prime example of healthcare system waste.

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January 27, 2010 — Today, the Society for Cardiovascular Angiography and Interventions (SCAI) launched "WINHeart — Score a WIN for Women," an initiative that raises awareness surrounding gender-based disparities in the diagnosis, treatment and survival of women with cardiovascular disease (CVD).

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Technology

February 3, 2010 – The new Gator ClipSeal Plug is designed to maintain a hemostatic seal around 0.035- or 0.038-inch guide wires within large hemostatic valve introducer sheaths to minimize blood loss.

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Technology

February 3, 2010 – The FDA granted 510(k) market clearance for Shina Systems’ 3Di advanced medical (3D/4D) visualization software that downloads over the Internet and provides a full suite of image processing and clinical analysis applications on any PC.

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February 3, 2010 – Results of a four-year study evaluating the safety and efficacy of laser assisted lead removal using the Spectranetics laser sheath (SLS II), found a 97.7 percent clinical success rate.

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Technology

February 2, 2010 - A second-generation transradial compression bracelet, the Zoom 2010, is being released by Zoom Co Medic. This bracelet is designed to obtain a stable compression of the radial artery, which will allow an uninterrupted flow of blood sufficient to protect the vascular system, while assuring adequate compression to avoid hematoma and encouraging prompt hemostasis.

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February 2, 2010 - Among noninvasive imaging tests for ruling out coronary artery disease (CAD), computed tomography (CT) is a more accurate noninvasive test than magnetic resonance imaging (MRI), according to a comparative study released in Annals of Internal Medicine.

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Technology

Engineered specifically for the carotid artery, Abbott's self-expanding Xact Stent uses a closed-cell, tight-mesh design allows for a high coverage area and better conformity to the carotid artery, reducing the release of plaque as well as the potential for snagging upon removal.

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