SynCardia is keeping us up to date with developments of its Total Artificial Heart system. Currently the company is focusing its efforts on making a smaller iteration of the device that it says will make it available to three times the number of people suffering from end-stage biventricular heart failure.
The need for these so-called bridge-to-transplant devices is highlighted by the stat that about 3,800 people wait for a heart transplant on any given day in the U.S. However while the need for donor hearts is increasing, the supply has been flat in the U.S. and generally been declining in Europe. The plain fact is that approximately 16% of people on the heart transplant list become too ill or die each year.
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. As such it has helped patients survive for months or years while waiting for a matching donor heart and is claimed to be 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.
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. But by coming up with a smaller 50cc version the company will bring the option of this life-saving device to people of smaller size, including most women, men and many adolescents.
Clinical trials of the smaller variant now await FDA approval and are expected to start later this year. These studies 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.
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.
For now though, the 50cc Total Artificial Heart 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.
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.
“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.”
Source: SynCardia Systems Inc., PR Newswire