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SynCardia Systems, Inc.

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These 7 Artificial Heart Facts Could Help Save Your Life

There have been 1,458 implants of 13 different artificial heart designs performed between 1969 and 2014. Did you know that one company that accounts for 96% of all hearts implanted into humans has a new size for smaller patients?

This chart from the 2014 Registry of the International Society of Heart and Lung Transplantation shows that heart transplants have flattened since 1999. It demonstrates that heart transplants are not keeping up with the increasing demand for donor hearts. This chart from the 2014 Registry of the International Society of Heart and Lung Transplantation shows that heart transplants have flattened since 1999. It demonstrates that heart transplants are not keeping up with the increasing demand for donor hearts. TUCSON, Ariz. – Feb. 3, 2015 – For patients suffering from end-stage biventricular (both sides) heart failure, a donor heart transplant is the standard of care. However, not all patients waiting for a donor heart will have one available to them when they need it to save their lives.

In the United States, approximately 16% of transplant-eligible patients on the list die or become too sick for a transplant while waiting for a donor heart.

Cardiovascular disease, including heart failure, kills more people than all cancers combined. As heart failure increases, so does the demand for donor hearts for transplants. Over the last 20 years the number of donor hearts available for transplant has remained flat or is declining, according to figures from the 2014 Registry of the International Society for Heart and Lung Transplantation.

The Total Artificial Heart is used as a bridge to transplant that helps save the lives of patients who cannot get donor hearts in time. The SynCardia temporary Total Artificial Heart is the most-used heart in the world. Its manufacturer, SynCardia Systems, Inc., is making this life-saving technology available to smaller patients and patients who are not transplant-eligible.

In Europe, two sizes of the SynCardia Total Artificial Heart—the 70cc and the 50cc—have the CE mark for use. Together, these two sizes will fit many adolescents and almost all adults who qualify for a SynCardia Heart implant as either a bridge to a matching donor heart transplant or for permanent use, also known as destination therapy. Use of the Total Artificial Heart for destination therapy varies by country.

In the United States, the 70cc SynCardia Total Artificial Heart is FDA-approved for use as a bridge to transplant. SynCardia Systems, Inc. is starting an FDA-approved clinical study of the effectiveness of the 70cc SynCardia Heart for destination therapy. (Caution-The 70cc SynCardia Total Artificial Heart, when used for destination therapy, is an investigational device, limited by United States law to investigational use.)

The company also is working with the FDA to begin a clinical study early in 2015 for the effective use of the 50cc SynCardia Heart as a bridge to a heart transplant. (Caution-In the United States, the 50cc SynCardia temporary Total Artificial Heart is an investigational device, limited by United States law to investigational use.)

Here are seven things you should know about artificial hearts.

1. Growing Demand for Artificial Hearts

Among European Union countries, 3,400 patients were on waiting lists for a donor heart in 2012. According to the European Commission’s Department of Health and Consumers, only 2,004 transplants were conducted that year.

On any given day, according to the U.S. Department of Health & Human ServicesU.S. Department of Health & Human Services, about 4,000 patients are waiting for a donor heart transplant. Meanwhile, the annual supply of approximately 2,300 donor hearts has been flat in the U.S. for over 20 years.

2. The Most Widely Used Artificial Heart

From 1969 through 2014 there have been 1,458 implants of 13 different artificial heart designs. The SynCardia Total Artificial Heart and its predecessors account for 1,397 or 96% of all implants–including two implants in Europe of the new smaller 50cc heart. The 50cc design fits patients of smaller stature, including women, smaller men and many pediatric patients who are eligible for a donor heart transplant.

More than 550 SynCardia Hearts have been implanted since January 2010.

3. Duration of Support for Patients on Artificial Hearts

In this age of donor heart shortages, the SynCardia Total Artificial Heart helps rescue patients dying from end-stage biventricular heart failure. Like a heart transplant, the Total Artificial Heart is the only approved device that eliminates the source of end-stage biventricular heart failure. The SynCardia Heart helps patients recover and regain their health and strength for transplant.

The longest a person has been supported by an artificial heart was Italian patient Pietro Zorzetto, who had a SynCardia Total Artificial Heart for nearly four years—1,374 days—prior to his successful heart transplant September 11, 2011.

Another patient was supported for 1,172 days—more than three years—on the SynCardia Heart until he was transplanted June 5, 2014. As of January 20, 2015, two other patients have now been supported for three-and-a-half years on the SynCardia Heart as they continue to await donor heart transplants.

One-third of current SynCardia Total Artificial Heart patients have been supported for more than a year (47% outside of the United States, 21% in the U.S.), including some who have been supported by the device for two years or more.

When all of the time that patients have been supported by total artificial hearts are added up, the SynCardia Total Artificial Heart accounts for 98.4%, or 443 patient years, of support. The other designs account for seven years.

4. Improved Quality of Life

The SynCardia Total Artificial Heart gives patients a second chance at life, and the Freedom® portable driver gives them the mobility to enjoy a near-normal lifestyle.

Clinically stable SynCardia Heart patients can be discharged from the hospital using the Freedom portable driver, which powers the SynCardia Heart. They can exercise, sleep more comfortably in their own beds, spend time with family and friends, enjoy recreation and, in some cases, even go back to work. All of these activities help patients regain health and be in better physical shape for their donor heart transplant.

5. Highest Bridge to Transplant Rate

According to data published in the 2004 New England Journal of Medicine2004 New England Journal of Medicine from the 10-year pivotal clinical study which led to FDA approval, 79% of patients who received the SynCardia Total Artificial Heart or its direct predecessors were bridged to transplant.

This is the highest bridge-to-transplant rate for any approved artificial heart or ventricular assist device in the world.

From June 23, 2006 to September 30, 2014, 72% of patients who had lived one year with the SynCardia Total Artificial Heart implant either received a donor heart transplant (60.5%) or were alive and waiting for a matching donor heart (11%), according to the third-quarter 2014 INTERMACS report.third-quarter 2014 INTERMACS report.

6. Reliable Elegant Design

For over 30 years, from December 2, 1982 to December 31, 2014, the SynCardia Total Artificial Heart and its direct predecessors have been implanted 1,397 times, which equates to 96% of all artificial heart implants.

Because of its elegant design, the SynCardia Total Artificial Heart doesn’t require sensors, motors or electronics of any type inside the body. There isn't a need to re-operate to repair faulty electronics. The only electronics needed are located outside of the body in the pneumatic drivers.

The Companion 2 hospital driver and the Freedom portable driver power the Total Artificial Heart with precisely calibrated pulses of air. This creates pulsatile blood flow similar to a beating human heart beat. The SynCardia Heart pumps up to 9.5 liters of blood per minute through each ventricle. The drivers also monitor blood flow for each ventricle.

7. Status of Currently Approved and Studied Devices

Only two artificial heart designs are FDA-approved: the SynCardia Total Artificial Heart and the AbioCor replacement heart.

The AbioCor replacement heart has been implanted a total of 15 times. The first 14 implants were part of its clinical FDA Humanitarian Use Device (HUD) Study. Following the September 2006 FDA approval of the device, only one AbioCor heart was implanted (2009).

The first implant of the Carmat bioprosthetic heart, whose design is similar to the AbioCor, was conducted December 18, 2013, under a clinical feasibility study. The patient died after 74 days.

The French health ministry confirmed to Reuters September 8, 2014 that a second Carmat artificial heart was implanted on August 5, 2014 at University Hospital of Nantes. News coverage in January 2015 reported that this patient has been discharged from the hospital.

The SynCardia Total Artificial Heart is available at more than 100 SynCardia Certified Centers in 17 countries to be implanted when physicians specializing in heart failure determine that the SynCardia Total Artificial Heart is needed to save the life of the patient and prevent damage to vital organs such as kidneys, liver, stomach, lungs and the brain.

 

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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.

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SynCardia Contact:
Janelle Drumwright, jdrumwright@syncardia.com, (520) 547-7463

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