New Smaller SynCardia Total Artificial Heart Will Expand Life-Saving Therapy to All Adults & Many Adolescents
Once Results of Studies Are Approved by the FDA, the Smaller 50cc SynCardia Heart and New Permanent Use Indication Will Triple the Number of Heart Failure Patients Who Can Get a 2nd Chance at Life
TUCSON, Ariz. – March 11, 2014 – Recent developments surrounding the SynCardia temporary Total Artificial Heart will make the life-saving device available to three times the number of people suffering from end-stage biventricular heart failure. Over 300 SynCardia Hearts have been implanted worldwide since 2012.
Clinical trials awaiting FDA approval will document the use of a new smaller 50cc version of the SynCardia Total Artificial Heart, making it available to people of smaller size, including most women, men and many adolescents.
The current 70cc SynCardia Total Artificial Heart, the world's first and only FDA, Health Canada and CE approved Total Artificial Heart, is approved as a bridge to transplant. It has been implanted in nearly 1,300 people worldwide.
Once approved by the FDA, the studies are expected to launch later this year. They will also investigate using the SynCardia Heart for permanent use (also known as destination therapy). This allows patients who do not qualify for a donor heart transplant — because of other health conditions or age — to receive a SynCardia Heart.
About 3,800 people wait for a heart transplant on any given day, according to the U.S. Department of Health & Human Services. The need for donor hearts is increasing, however. For over 20 years, the supply of approximately 2,300 donor hearts annually has been flat in the U.S. and the supply has generally been declining in Europe. Approximately 16% of people on the heart transplant list become too ill or die each year.
Many patients have lived with the SynCardia Heart for months or years while waiting for a matching donor heart. The longest a patient has lived with a SynCardia Heart was nearly four years before receiving a successful donor heart transplant. The SynCardia Total Artificial Heart is one of the most reliable approved heart devices. The valves in the heart have never failed and the diaphragms that pump the blood have a failure rate of less than 1% for nearly 1,300 implanted hearts, accounting for 2,600 ventricles.
Once the clinical trials are underway, both the 50cc and 70cc SynCardia Total Artificial Heart will be available as both destination therapy and bridge to transplant at study sites. The 70cc SynCardia Heart as a bridge to transplant is available at all SynCardia Certified Centers. Like a human heart transplant, the SynCardia Heart eliminates the symptoms and source of end-stage biventricular heart failure, when the left and right ventricles can no longer pump enough blood for the patient to survive.
SynCardia CEO and President Michael P. Garippa and Chief Technology Officer Rich Smith detailed these developments in a March 4, 2014 segment of “AZ Illustrated Science,” a Tucson Arizona news and public affairs show that airs on Public Broadcasting. They also provided an update about the Freedom® portable driver, which powers the SynCardia Heart.
The Freedom® portable driver, at only 13.5 pounds, provides patients with almost unlimited mobility. It is pending FDA approval and is approved by Health Canada and the CE Mark for Europe. A majority of clinically stable patients are discharged with the Freedom portable driver to recover at home and in their communities. At home, patients are able to sleep in their own beds, eat out, socialize and be part of their communities. Most patients exercise, helping them become stronger for their donor heart transplant.
“Freedom patients have proven that many activities and daily living are possible, including activities that we don’t necessarily endorse,” Garippa says of some patients. “We’ve had people go four-wheeling. We’ve had people doing tai chi. We’ve had people cycle, run, take driving vacations through many states and countries and do everything but swim.”
The 50cc Total Artificial Heart is designed for use as a bridge to transplant in patients of smaller stature, including women and adolescents. It has been designated as a Humanitarian Use Device (HUD) by the FDA for destination therapy in adults and as a bridge to transplant in pediatric patients. Prior to clinical study, an Investigational Device Exemption (IDE) application that includes each indication must be approved by the FDA.
CAUTION – The Freedom portable driver is an investigational device, limited by United States law to investigational use.
About SynCardia Systems, LLC
SynCardia Systems, LLC in Tucson, Ariz., is the privately-held manufacturer of the world's first and only FDA, Health Canada and CE approved Total Artificial Heart. For people suffering from end-stage heart failure affecting both sides of the heart (biventricular failure), the SynCardia temporary Total Artificial Heart is used as a bridge to transplant, helping them survive until a matching donor heart becomes available. SynCardia also manufactures the Freedom® portable driver, which powers the temporary Total Artificial Heart and allows clinically stable patients to be discharged from the hospital to enjoy life at home while they wait for a heart transplant.
Janelle Drumwright, firstname.lastname@example.org, (520) 547-7463