SynCardia Systems won 2 new Humanitarian Use Device designations for its 50cc Total Artificial Heart as a cardiac bridge transplant device.
The new HUD designations apply to use with children, smaller women and other people with small stature. The Tuscon, Ariz.-based device manufacturer designed this device as a smaller version of its 70cc temporary Total Artificial Heart, approved in 2004, according to a press release.
The HUD approvals are for destination therapy for patients at risk of imminent death from heart failure, and for a pediatric bridge-to-transplant for patients with small stature. This designation is estimated to cover a condition affecting fewer than 4,000 people in the U.S. per year.
"The 50cc Total Artificial Heart is designed to fit patients of smaller stature, including many women and adolescents who are too small to receive the 70cc Total Artificial Heart," said CEO Michael Garippa in a prepared statement. "We are pleased that the FDA recognized the needs of these under-served patient populations and was swift in approving the HUD designations."
SynCardia late last year recalled an external battery component of the Total Artificial Heart because of the potential risk of melting and charring. The company recently hired a new COO, Doulas Nutter, to oversee manufacturing and quality engineering for the total artificial heart.