HeartWare plunges on uncertainty around its next-gen MVAD pump

Shares of HeartWare International (NSDQ:HTWR) are down some 28% today after the implantable heart pump maker said it can’t predict when it will be able to get its next-generation MVAD program back on line. Framingham, Mass.-based HeartWare said it expects to post sales of roughly $68 million for the 3 months ended Dec. 31, in line with the consensus forecast on Wall Street for $67.2 million. But the company said its still evaluating date from a CE Mark trial of the MVAD left ventricular assist device that was halted last fall, which it now says show evidence of blood clots in the pump. The incidence of pump thrombosis could be due to software algorithms, HeartWare said. “We were hoping to be able to state when we expect to re-initiate the MVAD system clinical program with certainty, but it is essential that we complete our analysis and work with trial investigators and regulatory authorities on the path forward that enhances the opportunity for the MVAD system to realize its considerable potential,” CEO Doug Godshall said in prepared remarks. “While the initial MVAD clinical experience has not fully met our expectations, we have made meaningful progress in our investigation and have identified some software algorithms that we plan to adjust to improve pump performance. As the MVAD system is performing well on most fronts, we remain optimistic that an improved MVAD system will emerge from this additional evaluation.” Investors pared 30.0% from ...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Cardiac Assist Devices Clinical Trials Wall Street Beat HeartWare International Inc. Source Type: news