The Framingham, Mass.-based circulatory support technology company HeartWare International Inc. has received approval from the U.S. Food and Drug Administration (FDA) for its HeartWare ventricular assist system as a bridge to heart transplant.

The HeartWare ventricular assist system features the HVAD (HeartWare ventricular assists device) pump, a small full-support circulatory assist device (which can reportedly support a flow of up to 10 liters per minute) implanted next to the heart, avoiding the abdominal surgery generally required to implant similar devices. The HVAD pump weighs approximately 5 ounces and displaces a volume of approximately 50 milliliters. The system is intended for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure.

“FDA approval marks the culmination of an extensive clinical effort and represents an exciting advance in the treatment of late-stage heart failure patients,” said Doug Godshall, president and CEO of HeartWare. “We wish to extend our most sincere thanks to the patients, and to their families, for participating in the study of this innovative device, and we also are grateful to each of the nurses, coordinators, surgeons and cardiologists who provided care to those patients.”

“I’ve had the opportunity to work on the HVAD project since its conception over a decade ago,” said O.H. “Bud” Frazier, M.D., Chief of the Center for Cardiac Support, director of Cardiovascular Surgery Research, and co-director of the Cullen Cardiovascular Research Laboratories at the Texas Heart Institute in Houston. “The goal was to develop a miniaturized device with an integrated inflow cannula that could be placed within the pericardial sac, avoiding the necessity of creating a pump pocket with its attendant infection risks, as well as simplifying the surgical insertion. A second goal was elimination of mechanical bearings to suspend the impeller, designed to enhance durability and blood handling characteristics. Those of us who treat these challenging end-stage heart failure patients are fortunate to have this pericardial, wearless system available for our patients.”

Godshall added that the system is poised to begin commercialization immediately, first in the 50 U.S. hospitals that participated in the clinical studies, and then into other hospitals once training can be implemented.

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