It's been a long road for HeartWare International (Framingham, Massachusetts), but the company's patience and perseverance has finally paid off. The FDA has approved the company's premarket approval application (PMA) for its HeartWare ventricular assist system (VAS) as a bridge-to-transplantation (BTT) therapy for patients with end-stage heart failure. HeartWare submitted the PMA nearly two years ago (Medical Device Daily, Dec. 29, 2010). Read More
