Ninety percent of patients in the first human trial of HeartWare International Inc.‘s left ventricular assist implantable pump survived at least 180 days.
The clinical trial involved 50 patients in the United Kingdom, Austria, Germany and Australia who were implanted with the Framingham-based heart pump maker’s device, designed to enable heart transplant candidates to survive until transplatation.
The trial data indicates that 90 percent of patients implanted with the device survive six months and 86 percent survive for a year. On average, each patient used the device for 300 days. As of April 24, three patients had yet to complete the trial, with the last due to finish in early June.
The device is also undergoing a 150-patient trial in the United States to determine whether it’s suitable as a bridge to transplant.
In the completed trial, 94 percent of patients survived six months after receiving a transplanted heart. Seven patients died (three while still in the hopsital after receiving the device), six from “multi-organ failure” and one from hemorrhagic stroke, the company said.
