|Courtesy of HeartWare International|
Like most devicemakers in the cardiac space, HeartWare International ($HTWR) has been grappling with plummeting demand and tight revenue margins, but the company landed a major victory with the November FDA approval of its Ventricular Assist System, a miniature pump designed to save the lives of heart failure patients as they await transplants.
Because of its small size, the device can be implanted directly into the chest, unlike other left-ventricular-assist pumps that require abdominal surgery. That makes it ideal for younger, smaller or contraindicated patients who are unable to withstand more invasive procedures.
And HeartWare's data says it's just as effective: In a study of 140 patients with end-stage heart failure, the device reached its primary endpoint of a 94% survival rate after 6 months, performing as well as competing LVADs.
The device has been CE-marked since 2009, and HeartWare is in the process of rolling it out in the U.S., starting with the 50 hospitals that participated in the pivotal trial and moving on from there. And the commercialization effort is already paying off: In the third quarter, HeartWare's U.S. revenue dropped 51% over the prior year, but in preliminary fourth-quarter results, HeartWare said its overall sales jumped 40% on the strength of the Ventricular Assist System.