Terumo Heart has reported that the first U.S. patient implanted with its DuraHeart left ventricular assist system (LVAS) was discharged from the University of Michigan Health System in Ann Arbor, 15 days after receiving the device.
Chisato Nojiri, MD, PhD, CEO of Terumo Heart, said that the FDA allowed the company to begin the trial with no restriction on patient discharge.
The patient, a 62-year-old man from Livonia, Mich., suffering from heart failure for nearly 20 years, is the first U.S. patient to receive the DuraHeart LVAS that utilizes advanced magnetic levitation (Mag-Lev), according to the Ann Arbor, Mich.-based company.
Nojiri said its pump design combines Mag-Lev technology and a centrifugal pump, allowing for the elimination of mechanical contact within the blood flow path, minimizing the chance of mechanical failure. The device is intended to provide cardiac support for patients awaiting transplant who are at risk of death due to end-stage left ventricular failure.
The DuraHeart Bridge-to-Transplant Pivotal Trial is a multi-center, prospective, non-randomized study of 140 patients and will include up to 40 centers. The National Co-Principal Investigators are Francis Pagani, MD, PhD, from the University of Michigan and Yoshifumi Naka, MD, PhD, from Columbia Presbyterian Hospital in New York City, Terumo said.