News

Claret Medical announced the first patient has been successfully treated in its SENTINEL trial, a multicenter pivotal trial of the Sentinel cerebral protection system (CPS). The landmark trial is the first prospective, randomized, controlled, blinded trial in the United States to evaluate the role of cerebral protection during transcatheter aortic valve replacement (TAVR).

Home October 07, 2014
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Amaranth Medical announced patient enrollment in multiple centers in Colombia, South America in MEND-II, a clinical trial to assess safety and feasibility of the company's Fortitude Sirolimus-Eluting Bioresorbable Scaffold in patients with symptomatic coronary artery disease.

Home October 07, 2014
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Technology

Medtronic Inc. announced the U.S. launch of the SEEQ Mobile Cardiac Telemetry (MCT) System, an external, wire-free, adhesive heart monitor that can be worn for up to 30 days to help detect and diagnose the cause of irregular heartbeats in patients. Medtronic completed the acquisition of U.S.-based Corventis Inc., which developed the technology, in June 2014.

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Occlutech announced that it has obtained a European CE mark approval for its dedicated Paravalvular Leak Closure Device (PLD).

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The ASE Education and Research Foundation hosted a one-day event, Value-Based Healthcare: Summit 2014, Sept. 12 in Washington, D.C., which gathered thought leaders from across the healthcare spectrum to discuss cardiac imaging in the new value-based healthcare paradigm. The Summit culminated with the announcement that the ASE Foundation’s largest research grant in its history, a $200,000 multi-year grant, has been awarded to a research team from the University of Chicago led by Victor Mor-Avi, Ph.D., FASE, director of cardiac imaging research.

Home October 06, 2014
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St. Vincent Heart Center officials announced that the faith-based hospital is the second in the nation to implant the new investigational “heart pump.”

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Ekos for PE
Feature | Pulmonary Embolism | James M. McCabe, M.D., FACC, University of Washington, Seattle

Acute intermediate-risk pulmonary emboli (PE) in normotensive patients with right ventricle dysfunction present the clinician with a quandary. With a 3 percent mortality rate[1] — just shy of the mortality rate of acute myocardial infarction — acute intermediate-risk PE warrants therapy that will rapidly reduce right ventricular strain and pulmonary artery pressure. Systemic lytics, with a 2 to 3 percent[2] risk of catastrophic intracranial bleeding, has a major complication rate equal to the overall mortality of the disease. Yet standard anticoagulation often acts too slowly, achieving full efficacy in responsive patients over the course of weeks or even months. In fact, the recent PEITHO trial demonstrated a 5 percent need for rescue thrombolysis among patients receiving anticoagulation alone.

Home October 03, 2014
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Case Study

In the September issue of the Journal of the American Society of Echocardiography is the article "Expert Consensus for Multimodality Imaging Evaluation of Adult Patients during and after Cancer Therapy: A Report from the American Society of Echocardiography and the European Association of Cardiovascular Imaging.” These recommendations include echocardiographic assessment and monitoring of the left ventricle (LV) using ejection fraction (EF) and strain imaging, along with right ventricle (RV) using TAPSE, S’ and FAC for improved management of oncology patients at risk for cardiotoxicity. All these capabilities are provided in EchoInsight visualization and analysis in a workflow-enhancing, vendor-neutral software platform.

Home October 03, 2014
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October 3, 2014 — Esaote North America announced that its new MyLab Gamma ultrasound system has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and is now available for sale in the United States.

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Technology

W. L. Gore & Associates Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the Gore Viabahn Endoprosthesis for interventional treatment of in-stent restenosis in the superficial femoral artery (SFA).

Home October 03, 2014
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The Centers for Medicare & Medicaid Services (CMS) has determined that clinical sites that wish to participate in the newly announced CREST-2 carotid artery stenting (CAS) registry must receive accreditation.

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Feature

Boston Scientific Corp. has initiated the REPRISE III clinical trial, a pivotal study to evaluate the safety and effectiveness of the Lotus valve system in patients with severe aortic stenosis and who are considered to be at either high or extreme risk for surgical valve replacement.

Home October 02, 2014
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Claret Medical, Sentinel
Feature | Dave Fornell

While transcatheter aortic valve replacement (TAVR) is a paradigm shift in how valve disease is treated, one nagging safety issue that remains is TAVR’s stroke rate, which is higher than traditional surgical valve replacements. The solution to this issue may be the use of specialized embolic protection systems, of which four companies displayed their devices on the show floor and in presentations at the 26th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in September.

Home October 02, 2014
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Singulex Inc. announced the presentation of 10 abstracts at the European Society of Cardiology's (ESC) annual conference, which highlight the clinical utility of single molecule counting technology in the detection and quantification of biomarkers for cardiac disease, its comorbidities, and its risk factors.

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ReFlow Medical Inc. announced the initial clinical use of its Wingman35 Crossing Catheter and speX Shapeable Support Catheter by Dr. Andrej Schmidt at University Leipzig, Germany.

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