Yenra : Medical : Total Artificial Heart : Temporary pneumatic, biventricular, implantable system restores normal blood pressure and cardiac output

Artificial Heart

SynCardia's CardioWest Temporary Total Artificial Heart has been approved by the FDA as a bridge-to-transplantation in cardiac transplant-eligible candidates at risk of non-reversible biventricular failure.

This first FDA-approved temporary total artificial heart completely replaces the patient's diseased heart and immediately restores normal blood pressure and cardiac output, facilitating recovery of end-organ function, such as the kidney and liver. As a result, patients become better candidates for transplantation.

"The FDA's approval represents a significant milestone in medical history. With the total artificial heart, we will be able to save the lives of many critically ill patients who are in need of or who are awaiting heart transplants. The device fills an unmet medical need, and we are thrilled to offer this device to cardiac surgeons and cardiologists at heart transplant centers nationwide," said Dr. Marvin J. Slepian of SynCardia.

"Over nine years ago, we began collecting research and data on the efficacy of the device and today's approval from the FDA represents the culmination of our efforts," said Dr. Jack G. Copeland, Chief, Section of Cardiovascular and Thoracic Surgery, University of Arizona Sarver Heart Center. "This is a tremendous day not only for SynCardia but for all people and their families affected by non-reversible biventricular failure."

The temporary total artificial heart is a pneumatic, biventricular, implantable bridge-to-transplant system for full cardiac replacement, taking the place of the failing heart. The device offers full circulatory support and high cardiac output, helping patients become better candidates for eventual transplantation.

SynCardia develops biomechanical cardiac replacement and assist devices.