Investigational Device Exemption Application Submitted to FDA for Freedom[TM] Discharge Driver to Power SynCardia Total Artificial Heart.1(st) U.S. Discharge Driver Designed to Free Stable Total Artificial Heart Patients from the Hospital TUCSON, Ariz. -- On Nov. 5, SynCardia Systems, Inc. (www.syncardia.com), manufacturer of the SynCardia temporary CardioWest[TM] Total Artificial Heart, announced it has submitted an application to the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. to conduct an Investigational Device Exemption An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and (IDE) clinical study of the Freedom[TM] discharge driver, designed to power the Total Artificial Heart outside the hospital. "Stable Total Artificial Heart patients in the U.S. are currently confined con·fine v. con·fined, con·fin·ing, con·fines v.tr. 1. To keep within bounds; restrict: Please confine your remarks to the issues at hand. See Synonyms at limit. to the hospital by the large 'Big Blue' hospital driver that powers the heart," said Rodger Ford, SynCardia president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. . "The IDE submission includes a request to conduct the clinical study at 30 U.S. centers," said Mary Pat Sloan, VP of Global Training and Customer Support. "While many of our trial sites have been identified, we will be following up with additional transplant centers that have expressed interest in participating in the Freedom driver study." Later this month, SynCardia will submit the Freedom driver design dossier to the Notified Body for examination for the CE Mark in Europe. For more information, please visit http://www.syncardia.com. Originally used as a permanent replacement heart, the Total Artificial Heart is currently approved as a bridge to human heart transplant heart transplant Procedure to remove a diseased heart and replace it with a healthy one from a legally dead donor. The first was performed in 1967 by Christiaan Barnard. for patients dying from end-stage biventricular failure. The Total Artificial Heart is the only device that provides immediate, safe blood flow of up to 9.5 L/min through both ventricles Ventricles The two chambers of the heart that are involved in pumping blood. The right ventricle pumps blood into the lungs to receive oxygen. The left ventricle pumps blood into the circulation of the body to deliver oxygen to all of the body's organs and tissues. . The SynCardia Total Artificial Heart is the first and only FDA, Health Canada Health Canada (French: Santé Canada) is the department of the government of Canada with responsibility for national public health. Health Canada's goal is to improve Canadian life by improving Canadian longevity, lifestyle and use of public healthcare. and CE Mark approved Total Artificial Heart in the world. There have been more than 800 implants of the Total Artificial Heart, accounting for more than 170 patient years of life on the device. Photos/Multimedia Gallery Available: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=6092450&lang=en |
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