|HeartWare got FDA approval for its Ventricular Assist System--courtesy of HeartWare|
HeartWare ($HTWR) is gearing up to commercialize its Ventricular Assist System in the U.S. now that the FDA has granted its approval of the device, a mini pump designed to save heart failure patients awaiting transplant.
Unlike other available left ventricular assist devices that require abdominal surgery, HeartWare's miniaturized tech can be implanted in the chest, making it ideal for younger or smaller patients who are unable to withstand the other procedure.
The device got its CE mark in 2009, and, now that it has the FDA's blessing, HeartWare is ready for commercial rollout, planning to launch in the 50 hospitals that participated in clinical trials and expand from there, CEO Doug Godshall said.
In its pivotal study, HeartWare tested the device on 140 patients with end-stage heart failure, reaching its primary endpoint of a 94% survival rate after 6 months, and the device was found to perform just as well as competing LVADs.
The approval will likely be a salve for HeartWare's floundering U.S. revenue, which dropped 51% last quarter, and, considering HeartWare's perennial status as a rumored M&A target, the regulatory nod could do more than just boost sales. Thoratec ($THOR) swung and missed in a 2009 effort to buy the company, but HeartWare's recent successes will only make it more attractive--and, probably, more expensive.
- here's HeartWare's statement
- check out the FDA's release
Special Report: HeartWare International - Top M&A targets in devices and diagnostics