Cardiac Ultrasound Systems Point-of-Care Cardiology Clinical Study
Feature

A paper in the journal of the World Heart Federation, Global Heart, reported mounting evidence of the utility of ultrasound in areas outside its traditional field of cardiology, with increasing use reported in general hospital wards, clinics and pre-hospital environments. The paper is by Associate Professor Bret Nelson and Dr. Amy Sanghvi, Mount Sinai School of Medicine, New York.

Home January 29, 2014
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News

Biotronik enrolled the first patients in an expansion of their ongoing ProMRI trial to test its pacemaker system.Phase A of the study evaluated the safety of current Biotronik pacemaker systems during magnetic resonance imaging (MRI) scans with exclusion zones of the chest area, and was completed on November 18, 2013.

Home January 29, 2014
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The Gagnon Cardiovascular Institute at Morristown Medical Center adopted a minimally invasive medical device to treat patients with severe aortic stenosis who are too ill or frail to have their aortic valves replaced trough traditional open-heart surgery.

Home January 28, 2014
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Technology

January 28, 2014 — The U.S. Food and Drug Administration (FDA) approved W. L. Gore & Associates’ 25 cm Gore Viabahn Endoprosthesis with Heparin Bioactive Surface for the treatment of symptomatic peripheral arterial disease (PAD) lesions in the Superficial Femoral Artery (SFA). The 25 cm endoprosthesis is designed to cover long-segment lesions in the SFA, potentially reducing the need for multiple devices.

Home January 28, 2014
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ReCor Medical advanced its Paradise System for renal denervation (RDN) for treatment resistant hypertension (HTN).

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Technology

The U.S. Food and Drug Administration (FDA) approved Pressure Products Inc.’s SafeSept Needle Free Transseptal Guidewire for use with any introducer system when crossing the interatrial septum. The device assists in transseptal procedures and is designed to create the primary puncture in the interatrial septum providing access from the right to left side of the heart without using a transseptal needle.

Home January 28, 2014
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Technology

AtheroMed, a developer of catheter technologies for treating peripheral artery disease (PAD), received clearance from the U.S. Food and Drug Administration (FDA) to market the Phoenix Atherectomy System, which allows physicians to treat PAD with a low profile atherectomy catheter that continuously removes diseased material as it is debulked and does not require specialized capital equipment.

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Experts from the American Society of Echocardiography (ASE), in collaboration with the Society for Cardiovascular Magnetic Resonance (SCMR) and the Society for Pediatric Radiology (SPR), released a guideline, Multimodality Imaging Guidelines for Patients With Repaired Tetralogy of Fallot: A Report from the American Society of Echocardiography Writing Group, to help optimize lifetime management of patients with repaired tetralogy of Fallot (TOF).

Home January 28, 2014
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A paper in World Heart Federation’s journal Global Heart advocates for the inclusion of ultrasound in medical education programs to fully realize its benefits as early as possible. The review is by J. Christian Fox, professor of clinical emergency medicine and director of instructional ultrasound, University of California Irvine School of Medicine and colleagues.

Home January 28, 2014
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Claret Medical Inc. received CE marking for the Sentinel Cerebral Protection System (CPS) for embolic protection during transcatheter aortic valve replacement (TAVR).

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Sapien 3, TAVR, CE mark, european approval
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Edwards Lifesciences Corp. received CE marking for its Edwards Sapien 3 transcatheter aortic valve.

Home January 28, 2014
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Experts presented six-month LEVANT 2 trial results for C. R. Bard Inc.’s Lutonix drug coated balloon (DCB) and provided updates on the ongoing Lutonix Below the Knee (BTK) Clinical Trial at the Leipzig Interventional Course (LINC) in Leipzig, Germany.

Home January 28, 2014
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Prof. Richard Schilling implanted St. Jude Medical Inc.’s Nanostim retrievable leadless pacemaker at St. Bartholomew’s Hospital, London.

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Infraredx Inc.’s TVC Imaging System will be manufactured and distributed in Japan by Nipro Corp. Infraredx intends to commercialize the TVC Imaging System in Japan, China, Korea and other Asia Pacific markets.

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BioLeonhardt, a Leonhardt Ventures company based in Los Angeles, unveiled its implantable stem cell pump at the 9th Annual Cell Therapy for Cardiovascular Disease meeting at Columbia University, Jan. 23, 2014.

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