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SynCardia temporary Total Artificial Heart
SynCardia temporary Total Artificial Heart
The SynCardia temporary Total Artificial Heart is the world's first and only FDA, Health Canada, and CE approved Total Artificial Heart. It has been implanted in over 1,400 patients, accounting for more than 400 patient years of life on the device. Initially used as a permanent replacement, it is now approved as a bridge to transplant for patients with end-stage biventricular heart failure.
Approvals
The device received FDA approval on October 15, 2004, following a decade-long pivotal clinical study. It was awarded the CE Mark on May 16, 2005, and Health Canada approval on October 27, 2005.
Features
The Total Artificial Heart is unique in eliminating symptoms and the source of end-stage biventricular failure by replacing both failing heart ventricles and the four native heart valves. It is the only device capable of pumping up to 9.5 L/min through both ventricles, facilitating faster recovery of vital organs and improving transplant candidacy. Its partial fill/full eject design allows blood flow to adjust based on the patient's activity level.
Reliability
With over 30 years of use, the diaphragm has a failure rate of less than 1% across more than 1,400 implants. The device contains no internal motors or electronics; all electronics are external, housed in the pneumatic driver that powers the heart and monitors blood flow.
Specifications
The SynCardia Total Artificial Heart weighs 160 grams and has a stroke volume of 70 ml. It requires no internal electronics, ensuring reliability and ease of use.
Catalog excerpts
Fact Sheet: SynCardia temporary Total Artificial Heart Overview World’s first and only FDA, Health Canada and CE approved Total Artificial Heart More than 1,400 implants of the Total Artificial Heart, account for over 400 patient years of life on the device Originally used as a permanent replacement heart, the SynCardia Total Artificial Heart is currently approved as a bridge to transplant for patients dying from end-stage heart failure affecting both ventricles (biventricular failure). FDA approval: Oct. 15, 2004 (following a 10-year pivotal clinical study) CE Mark: May 16, 2005 Health Canada: Oct. 27, 2005 SynCardia Total Artificial Heart Weight: 160 grams Stroke volume: 70 ml The Total Artificial Heart is the only device that eliminates the symptoms and source of end-stage biventricular failure. Similar to a heart transplant, the Total Artificial Heart replaces both failing heart ventricles and the four native heart valves. Only device that pumps up to 9.5 L/min through both ventricles This high volume of safe blood flow helps vital organs recover faster, helping make patients better transplant candidates. Unique partial fill/full eject design allows the patient’s body to determine blood flow based on activity level Diaphragm has a failure rate of less than 1% over more than 1,400 implants (2800+ diaphragms) No motors or electronics of any type inside the body All electronics are located outside the body in the pneumatic driver, which powers the SynCardia Total Artificial Heart and monitors blood flow 1992 E. Silverlake Rd. Tucson, AZ 85713 www.syncardia.com SynCardia Total Artificial Heart No internal electronics required Media Contact: Don Isaacs VP of Communications (520) 955-0660 [email protected]
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