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St. Jude Medical Inc. has received CE Mark approval of its next-generation Ellipse and SJM Assura portfolio of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). The new portfolio is designed to lower the risk for lead abrasion and to ensure high-voltage therapy delivery.

Home May 16, 2013
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Technology

Vascular Solutions Inc. announced that it has re-launched the Venture catheter, a deflectable-tip catheter used to provide guidewire directional control in challenging coronary and peripheral interventional procedures. The device is available immediately in the United States and expected to become available in select international markets over the next few months.

Home May 15, 2013
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The Spectranetics Corporation announced the U.S. Food and Drug Administration's (FDA) approval of its adjunct analysis plan associated with the EXCITE ISR clinical trial, studying the treatment of in-stent restenosis (ISR) in the legs. The goal of the adjunct analysis plan is to demonstrate statistically significant clinical superiority of laser atherectomy plus balloon angioplasty (PTA) compared with PTA alone, prior to full enrollment of the EXCITE ISR study.

Home May 15, 2013
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ScottCare unveiled new advances for importing, monitoring and reviewing cardiac implantable electronic device (CIED) data at this year’s Heart Rhythm Society’s scientific session last week.

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New study data released at the Heart Rhythm Society (HRS) meeting last week validates the importance of contact force technology focused on improving the efficacy and safety of catheter ablation for the treatment of cardiac arrhythmias. Unveiled in HRS abstracts, the data also demonstrated the ability of the Endosense TactiCath ablation catheter to detect excessive contact force during robotic catheter navigation.

Home May 15, 2013
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Technology

Heart IT has released its WebPaxUniversal Viewer as an addition to its product portfolio. The new system allows hospitals and clinics to add Web-based, fully diagnostic image viewing to their existing infrastructure for both radiology as well as complex moving cardiology images. The WebPax Universal Viewer offers the same Web-based, zero-footprint image viewing technology that was first developed and patented by Heart Imaging Technologies.

Home May 15, 2013
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nContact Inc. said it received conditional approval for an investigational device exemption (IDE) from the U.S. Food and Drug Administration (FDA) to begin enrollment in the CONVERGE trial, a multicenter, prospective, randomized study evaluating patients with symptomatic persistent atrial fibrillation (AF). AF is the most common cardiac arrhythmia, a condition that disrupts the ability of the atria (upper chambers of the heart) to beat regularly and pump blood efficiently. The CONVERGE study, designed to investigate the epicardial/endocardial Convergent Procedure, combines the cardiac ablation expertise, techniques, and technologies of both electrophysiologists and cardiothoracic surgeons.

Home May 14, 2013
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Biosense Webster Inc. announced the 12-month safety and effectiveness results of the Thermocool Smarttouch catheter and software module in the treatment of symptomatic, drug refractory, paroxysmal atrial fibrillation (AF) from the SMART-AF investigational device exemption (IDE) clinical trial. The results were presented at the Heart Rhythm Society’s 34th Annual Scientific Sessions by Andrea Natale, M.D., a member of the study advisory committee and executive medical director of the Texas Cardiac Arrhythmia Institute at St. David’s Medical Center in Austin, Texas.

Home May 14, 2013
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CardioPET
Feature | Thijs Spoor

The next generation of positron emission tomography (PET) imaging agents will herald an age when PET will eclipse single photon emission computed tomography (SPECT) as the “go to” modality for molecular imaging. It will do so by enabling personalized medicine through precision diagnostics, the ability to be delivered cost-effectively in a manner with less radiation to patients, by leveraging hardware advances already being commercialized, and by taking advantage of the extra throughput capacity present in the U.S. installed base of PET/CT scanners.

Home May 14, 2013
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Technology

Toshiba America Medical Systems Inc. offers electrophysiology (EP) clinicians an Infinix-i cardiovascular X-ray system tailored for EP procedures with a new package of features, accessories and technologies. This package maximizes room utilization, improves workflow and enhances safety.

Home May 14, 2013
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Nanostim, pacemaker
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The first patient tests of a new leadless pacemaker show that the device can deliver the same life-saving therapy as a traditional single-chamber pacemaker without potential lead-related complications. The findings are part of the LEADLESS trial and were released at Heart Rhythm 2013, the Heart Rhythm Society’s 34th Annual Scientific Sessions.

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Wearable cardioverter defibrillators (WCD) can be an effective therapy option for patients with a transient or undefined arrhythmic risk, according to the WEARIT-II Registry, the largest prospective study to track patients with the device in a real-world setting. The new findings show that WCDs can serve as a bridging therapy and help avoid unnecessary permanent implantation of defibrillators in patients who ultimately may not need them.

Home May 14, 2013
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Biotronik announced the U.S. Food and Drug Administration (FDA) granted approval for its Ilesto 7 implantable cardioverter-defibrillator/cardiac resynchronization therapy defibrillator (ICD/CRT-D) series. The devices are smaller, thinner and lighter than previous systems.

Home May 14, 2013
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The American Society of Nuclear Cardiology (ASNC) testified at a U.S. House Ways and Means Health Subcommittee hearing that examined options for repealing the sustainable growth rate (SGR) formula and reforming the Medicare physician payment system to reward quality and value in patient care. Kim Allan Williams, M.D., ASNC past-president and a current member of the society’s health policy steering committee, testified as a witness in the hearing on May 7, 2013. Williams currently serves as the Dorothy Susan Timmis endowed professor and chairman of the division of cardiology at Wayne State University School of Medicine.

Home May 14, 2013
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Feature | Dave Fornell

During the American College of Cardiology 2013 (ACC.13) annual meeting in March, vendors discussed several trends they are observing in the cardiac ultrasound market and displayed the latest echo advances.

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