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SynCardia Systems (Tucson, Arizona), a developer of cardiac replacement and assist devices, in mid-October received final FDA approval for its CardioWest Temporary Total Artificial Heart (TAH-t) formerly the CardioWest Total Artificial Heart as a bridge to heart transplantation. Specifically, the approval is for use in cardiac transplant-eligible candidates at risk of imminent death from non-reversible biventricular failure.
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Adam Berman has been named vice president, research and development for MedicalCV (Minneapolis). He most recently was a regional sales manager for cardiac surgery-focused Coalescent Surgical. Medical CV is focused on developing products for improved patient outcomes by early treatment of cardiovascular disorders.
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The Centers for Medicare & Medicaid Services (CMS; Baltimore) recently asked the Heart Rhythm Society (HRS; Washington) to lead a working group to make recommendation for a national implantable cardioverter defibrillator (ICD) registry. Late in September, CMS posted a draft national coverage determination to expand coverage of ICDs.
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Dade Behring (Deerfield, Illinois), the University of Frankfurt (Frankfurt, Germany) and Innovectis (also Frankfurt) have signed an exclusive license agreement that provides Dade Behring with worldwide rights for the inventions of a research group at the university that relate to placental growth factor (PlGF) for cardiovascular diseases, soluble CD40 ligand for the prognosis of the course of disease in acute coronary syndrome (ACS), and additional markers for cardiovascular diseases.
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Edwards Lifesciences (Irvine, California) reported that it has enhanced its core heart valve business with the acquisition of all technology and intellectual property associated with ev3s (Plymouth, Minnesota) percutaneous mitral valve repair program for roughly $15 million.
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At the 16th annual Transcatheter Cardiovascular Therapeutics (TCT) meeting in Washington in late September, companies big and small presented compelling data from various studies for new products that they hope will lead to newly approved products in the interventional cardiology sector as well as showcased recently cleared devices that could potentially revolutionize the medical field.
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Many adults do not understand health information. Nearly half of all American adults 90 million have difficulty understanding and using health information, and there is a higher rate of hospitalization and use of emergency services among patients with such limited health literacy, states a new report from the Institute of Medicine (IOM).
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Recent studies in intensive care units1 (ICU) have found that critical care specialists often try to base decisions about withdrawal of advanced life support measures based on their perception of the patients wishes and the likelihood of survival in the ICU. But making accurate decisions about a patients wishes in such situations often requires clinicians to communicate effectively with surrogate decision makers members of the patients family or others empowered to make decisions should the person become incapacitated.
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The U.S. Food and Drug Administration has announced a qualified health claim for reduced risk of coronary heart disease on conventional foods that contain the omega-3 fatty acids eiscosapentaenoic acid and docosahexaenoic acid.
