News

The first implantation of Tyrx Inc.’s new AigisRx R Fully Resorbable Antibacterial Envelope has taken place at the Vanderbilt Heart and Vascular Institute in Nashville, Tenn., by Christopher R. Ellis. The AigisRx R Antibacterial Envelope received U.S Food and Drug Administration (FDA) clearance on May 20, 2013.

Home August 15, 2013
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Colibri Heart Valve LLC announced that enrollment its first-in-human feasibility study is continuing, and early clinical results from the second implantation of the Colibri device confirm the positive clinical findings observed in its first use. The Colibri transcatheter aortic valve implantation (TAVI) system is the first low profile, 14 French, pre-mounted, pre-crimped, and pre-packaged, ready-for-use TAVI system.

Home August 14, 2013
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IMRIS Inc. has obtained regulatory CE mark for Visius iCT, the first and only ceiling-mounted intraoperative computed tomography (CT), allowing for sales and marketing in the European Union.

Home August 13, 2013
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The William Stamps Farish Fund in Houston has donated $400,000 to a collaboration between the Institute for Computational Engineering and Sciences (ICES) at The University of Texas at Austin and the Texas Heart Institute (THI) to study life-threatening vulnerable plaques, the cause of at least two-thirds of all heart attacks, and new ways to prevent them.

Home August 13, 2013
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Technology

August 12, 2013 — Ambio Health, a healthcare technology company specializing in health monitoring systems, announced its Ambio remote health monitoring system, a wireless remote health and activity monitoring tool, received Class II 510(k) clearance from the U.S. Food and Drug Administration (FDA).

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Positron Corporation entered into a multi-year radioisotope supply agreement with iThemba LABS of Cape Town, South Africa. The supply agreement contracts the procurement of raw material, strontium-82 (Sr-82) from iThemba LABS for further production of the active pharmaceutical ingredient (API) at Positron's radioisotope production facility in Lubbock, Texas. In September 2013, Positron will receive relevant volumes of strontium-82 for qualification and will commence with commercial availability beginning in February 2014. This additional supply will enhance the industry's strontium-82 supply and increase the availability of radiopharmaceuticals to the end user. Positron intends to make this Sr-82 API supply available to all rubidium-82 generator producers in the marketplac

Home August 09, 2013
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Technology

NDS Surgical Imaging (NDSsi) has released its DomeAccess remote picture archive and communication systems (PACS) management software tool. DomeAccess software allows users to manage their Dome diagnostic display workstations from anywhere in the world.

Home August 08, 2013
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Technology

Sorin Group has received 510(k) clearance for commercialization of Sorin Connect, Sorin Group’s perfusion electronic charting system. The new Sorin Connect perfusion electronic charting system allows real-time data recording and trends visualization aimed to support clinicians and institutions in their perfusion management and documentation goals, during and after cardiac surgery.

Home August 08, 2013
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The U.S. Food and Drug Administration (FDA) accepted Biomedica’s Investigational New Drug (IND) application for ClotFoam, a novel hemostat for intraoperative hemorrhage. The company will now conduct clinical trials supported by the National Heart Lung and Blood Institute of the National Institutes of Health. ClotFoam was originally conceived to control severe hemorrhage without need of compression in order to address unmet needs in gynecology, combat trauma and emergency medicine, as well as treatment of trauma in the operating room. Current trials are designed to prove the safety and efficacy of the product as an adjunct in solid organ hemorrhage. Once the agent is approved for this indication, the company will conduct additional trials as a primary treatment in trauma patients.

Home August 08, 2013
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W. L. Gore & Associates announced a favorable ruling involving the Gore Helex Septal Occluder. The Hon. Judge Joan Ericksen of the U.S. District Court for the District of Minnesota ruled on July 23, 2013 in Gore’s favor that the Gore Helex Septal Occluder does not infringe the asserted claims of AGA Medical Corp.’s U.S. Patent 5,944,738 (‘738 patent) and granted Gore’s request for summary judgment of non-infringement.

Home August 07, 2013
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Nanostim, leadless pacemaker
Feature | Dave Fornell

There have been several advances in electrophysiology (EP) technologies this past year, many of which were highlighted during the Heart Rhythm Society (HRS). These advances included a leadless pacemaker, new data on contact force sensing ablation catheters, a new electromapping system entering the market and new techniques to map and ablate atrial fibrillation (AF), said Jagmeet Singh, M.D., Ph.D., director, resynchronization and advanced cardiac therapeutics program at the new Mass General Institute for Heart, Vascular and Stroke Care. Singh also presented numerous sessions at HRS.

Home August 06, 2013
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A clinical study of two sets of 894 matched emergency department (ED) patients presenting with chest pain revealed that the use of coronary computed tomographic angiography (CCTA) led to fewer hospital admissions and shorter ED stays. According to lead researcher Michael Poon, M.D., of Stony Brook University School of Medicine, the findings provide evidence that CCTA offers an alternative means of improving the triage of chest pain patients.

Home August 06, 2013
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Vanderbilt Heart and Vascular Institute is participating in the VELOCITY study, a randomized controlled clinical study to assess the safety and feasibility of a rapid cooling system for heart attack patients that could minimize damage to the heart.

Home August 06, 2013
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Edwards Lifesciences received conditional investigational device exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to initiate a clinical trial of its Edwards Sapien 3 transcatheter aortic heart valve and accessories.

Home August 06, 2013
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August 5, 2013 — AstraZeneca announced results from a new sub-analysis of the PLATO study that evaluated the incidence of stent thrombosis in patients with acute coronary syndrome (ACS).

Home August 05, 2013
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