HeartWare, one of the two major makers of left ventricular assist devices sold in the United States, has had a tough year. The company announced a slew of recalls, including an alarm battery failure and the potential for damage to the driveline connector. In October, its main competitor, Thoratec, was acquired by large cardio company St. Jude Medical. HeartWare has had to defend itself against urgings from an activist investor to end its proposed acquisition of Valtech Cardio.

The company’s next-generation MVAD was being studied in a CE Mark trial before the study was paused to allow for a minor circuit board fix for the device’s external controller. Management is also examining certain MVAD patient adverse events and expects to be able to restart the trial soon without a pump redesign. The exact timeline is not yet clear.

Perhaps 2016 will bring better news. On a recent earnings call, Doug Godshall, HeartWare’s president and CEO, said management is “incredibly bullish about HVAD, about return to clinic for VAD, and about the prospects for an incredible blending of two extremely strong teams of HeartWare and Valtech,” according to a Seeking Alpha transcript.

[image courtesy of HEARTWARE]

Start 2016 off right by attending MD&M West, the world's largest medical design and manufacturing event, February 9-11, at the Anaheim Convention Center.