Leading heart pump maker HeartWare International recently revealed that it has strengthened its HeartWare Ventricular Assist System portfolio in Europe with the CE Mark extension for long-term use in patients susceptible to fatal heart failure. The company has also published the U.S. clinical results of ADVANCE, an Investigational Device Exemption (“IDE”) study, designed to test the system as a bridge to heart transplantation for advanced heart failure patients.
The expanded CE Mark label followed the success of the international trial, which resulted in high survival rates of critically ill patients and also the extended usage of ventricular assist devices (“VAD”) in Europe.
The results of the U.S. ADVANCE Bridge-to-Transplant (“BTT”) trial, published in the American Heart Association's journal Circulation, reported positive patient outcomes of 140 candidates who were treated with the HeartWare investigational device. It was observed that survival rates and quality of life improved at 180 day following the treatment. Some of the risks associated with the system include infection, bleeding, perioperative right heart failure and stroke.
The HeartWare Ventricular Assist System comprises a small blood pump called HVAD pump, surgical tools and patient accessories, which help a patient’s weak heart to pump blood from the left ventricle into the aorta. About 2,000 HeartWare Ventricular Assist Systems have been implanted in patients globally. The device was cleared in the European Union in 2009 and in Australia in March 2011. Recently, the company revealed 50 clinical sites in the U.S. along with 91 customer sites in 25 nations.
Currently, the HeartWare Ventricular Assist System is not available commercially in the U.S.. The device is the subject of clinical trials in the U.S. for two indications, namely, BTT under continuous access protocol and destination therapy (“DT”). HeartWare submitted a Pre-Market Approval (“PMA”) application with the U.S. Food and Drug Administration (“FDA”) for the BTT indication in December 2010. The PMA includes data from the ADVANCE trial.
FDA's Circulatory System Devices Advisory Committee, in April 2012, announced that the advantages of using the HeartWare Ventricular Assist System outweigh the risks associated with it.
HeartWare makes miniaturized implantable heart pumps, also known as ventricular assist devices, which are used for the treatment of patients at a risk of advanced heart failure. The company competes in the heart devices market with Thoratec Corporation among others.