FDAnews Device Daily Bulletin
Medical Devices / Research and Development

HeartWare Pauses Enrollment in Clinical Trial of MVAD Heart Pump

Sept. 14, 2015

Framingham, Mass.-based HeartWare International says it is pausing enrollment in a clinical trial of its MVAD heart pump as it seeks to fix an issue with the manufacturing process for the left ventricular assist device’s controller.

CEO Doug Godshall says the problem involves the way a circuit board is fastened inside the controller, and that the company should have an upgrade of the manufacturing process by late September or early October.

The prospective study, launched in July, is slated to enroll 60 patients. The patients will be implanted with the MVAD pump through sternotomy or thoracotomy, with a primary endpoint of survival at six months.

Godshall says the trial pause will push back the expected timeline on the MVAD pump by a month or two. — Michael Cipriano