SynCardia Systems said today that it won FDA approval for a clinical trial of its artificial heart as a bridge to transplant for patients with heart failure.
The FDA granted an investigational device exemption for a 30-patient study of its smaller, 50cc total artificial heart device for the BTT indication, Tucson, Ariz.-based SynCardia said.
In January SynCardia won an FDA nod for another IDE trial of the 70cc device as a destination therapy. The BTT trial is slated to include 10 pediatric patients 10-18 years old, 10 adult patients 19-75 years old and 10 patients who would not otherwise qualify under the study criteria, the company said.
"This study will allow smaller patients who can’t fit the 70cc total artificial heart to benefit from SynCardia’s total artificial heart technology. Together, both device sizes are intended to make total artificial hearts available to most women and men as well as many adolescents," president & CEO Michael Garippa said in prepared remarks.
Last year SynCardia raised $14 million for the development of the smaller, BTT version of its flagship device.