HeartWare pauses MVAD trial

HeartWare International (NSDQ:HTWR) today said it’s pausing enrollment in a clinical trial of its next-generation MVAD heart pump while it looks to fix an issue with the manufacturing process for the left ventricular assist device’s controller. Framingham, Mass.-based HeartWare said none of the MVADs in the study are involved in the controller manufacturing issue, which does not affect the performance of the pump. The prospective, non-randomized, single-arm study, launched in July, is slated to enroll 60 patients, who will be implanted with the MVAD pump via sternotomy or thoracotomy, with a primary endpoint of survival at 6 months. Today CEO Doug Godshall told analysts at the Wells Fargo healthcare conference in Boston that the trial pause pushes back the expected timeline on CE Mark approval in the European Union by “a month or two,” meaning February or March 2016. The delay shouldn’t affect the expected timing on a U.S. trial for the MVAD, which is slated for the end of this year or early next year, Godshall said.   HeartWare also said it expects to take a $7 million to $9 million charge during the 3rd quarter as it looks to fix problems flagged in an FDA warning letter last year. The federal safety watchdog cited violations in design and software validation as well as complaint management and documentation, according to the FDA notice. The warning cites in particular the potential mismanagement of at least 27 complaints about Heart...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Cardiac Assist Devices Clinical Trials Food & Drug Administration (FDA) HeartWare International Inc. Source Type: news