(RxWiki News) The US Food and Drug Administration officials have approved a new heart pump designed to benefit patients with advanced heart failure awaiting a heart transplant.
The HeartWare Ventricular Assist System, produced by HeartWare International, is already available in 27 countries including Europe. About 2,500 patients outside the US already have received the pump.
The FDA said this device lowers the risk of infection and the device is easier for surgeons to implant. Also, the device was designed for enhanced durability and better blood handling characteristics.
"Ask your cardiologist to suggest heart failure treatments."
Doug Godshall, president and chief executive officer of HeartWare, said the approval comes following extensive clinical trials. He said the pump represents an "exciting advance" for late-stage heart failure patients.
The HeartWare system has a HVAD pump, a miniature device weighing about 5 ounces that offers full circulatory support. It is implanted next to the heart, allowing patients to skip the abdominal surgery usually involved when a similar device is implanted. The device is designed for patients with end-stage left ventricular heart failure in need of a bridge prior to a transplant.
O.H. "Bud" Frazier, MD, chief of the Center for Cardiac Support, director of Cardiovascular Surgery Research, and co-director of the Cullen Cardiovascular Research Laboratories at Texas Heart Institute, noted that in developing the device, one goal was the integrated inflow cannula placed in the heart's pericardial sac so doctors don't have to create a pump pocket.
Approval of the device was primarily based on the company's ADVANCE clinical trial, which followed 140 patients at 30 US hospitals with end-stage heart failure. All participants were implanted with the then-investigational HeartWare device between August 2008 and February 2010.
At six months, 94 percent of patients were still alive. Investigators concluded the device was not inferior, a key component in winning FDA approval.
As a condition of FDA approval, the company must complete a post-approval study of 600 patients receiving the HeartWare device and an additional 600 individuals from a database that receive other types of heart pumps. The company also must compile data from ADVANCE into a post-approval database and keep their obligation to offer continued education and training regarding the device.
HeartWare already also has completed enrollment for a 450-person study at 50 US sites. Patients received the device in May and will be followed for two years.