FDA OK's new heart transplant method at Connecticut hospital

The FDA greenlighted a new heart transplant method for use in a clinical trial at Yale New Haven (Conn.) Hospital that would significantly expand the amount of eligible donor hearts. 

The method, donation after circulatory death, allows surgeons to revive the heart after it has stopped beating and evaluate whether it's suitable for transplant. Once removed, the heart is connected to an organ care system. 

A 90-person clinical trial using the method will take place across 25 participating sites, including YNHH. 

"Bringing DCD to the U.S. will increase the donor pool by 30 percent," said Muhammed Anwer, MD, cardiac surgeon at the hospital's Heart and Vascular Center. 

The FDA approved the hospital's use of the method under Continued Access, a pathway for treatment outside of the clinical trials. 


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