News | August 21, 2008

First U.S. Implant of the HeartWare LVAS Announced

August 22, 2008 - HeartWare Ltd. this week said the first patient in the U.S. received the HeartWare Left Ventricular Assist System (LVAS) at Washington Hospital Center (WHC) in Washington, D.C.

This marks the start of HeartWare’s U.S. Bridge-to-Transplant clinical trial, under which 150 patients awaiting heart transplantation will be enrolled at up to 28 participating centers. The HeartWare LVAS features a miniature blood pump that can be placed adjacent to the patient’s heart, and is designed to avoid potentially more complicated abdominal implantation. The system is designed to provide circulatory support for patients with advanced heart failure. The HeartWare LVAS is limited to investigational use in the U.S.

The principal investigator at WHC is Dr. Leslie Miller. The surgery was performed by Steven Boyce, M.D., surgical director, heart failure program at WHC.

“Like many of our colleagues, we have been closely watching HeartWare’s progress and have been impressed by the results from the international clinical trial,” said Drs. Miller and Boyce in a joint statement. “We at Washington Hospital Center are pleased to have been the first to implant this exciting new device. The surgery was quick and without incident and the patient is recovering well. The novel configuration of the HeartWare device together with its small size allow the pump to be implanted in the pericardial space, potentially reducing the risks associated with more extensive surgery. The pump has one moving part, an impeller that utilizes a passive suspension system designed to minimize mechanical wear and friction while pumping. We look forward to Washington Hospital Center’s continued use of the device through the course of this trial.”

The company expects a number of additional centers to complete their internal review processes and to begin enrolling patients over the next several months.

For more information: www.heartware.com.au

Related Content

CorWave's Next-generation Neptune LVAD Receives Funding

Image courtesy of CorWave

News | Ventricular Assist Devices (VAD) | July 11, 2018
French-based CorWave announced that its CALYPSO program has received 14 million euros to develop CorWave Neptune, a new...
Abbott Recalls the HeartMate 3 Left Ventricular Assist System, LVAD
News | Ventricular Assist Devices (VAD) | May 23, 2018
Abbott has initiated a Class I recall of the HeartMate 3 Left Ventricular Assist System due to a malfunction in the...
FDA Approves Abiomed Impella CP With SmartAssist and Optical Sensor
Technology | Ventricular Assist Devices (VAD) | April 02, 2018
Abiomed Inc. announced that it received U.S. Food and Drug Administration (FDA) Pre-Market Approval (PMA) for its...
Reduced Device Clotting, Decreased Strokes Seen With HeartMate 3 at Two Years
News | Ventricular Assist Devices (VAD) | March 13, 2018
At two years of follow-up, severely ill patients with advanced heart failure who received a novel heart pump fully...
Medtronic HeartWare HVAD System Approved for Destination Therapy
Technology | Ventricular Assist Devices (VAD) | October 04, 2017
October 4, 2017 — Medtronic received U.S.
Abiomed Receives FDA PMA Approval for Impella RP for Right Heart Failure
Technology | Ventricular Assist Devices (VAD) | September 28, 2017
Abiomed Inc. recently received U.S. Food and Drug Administration (FDA) pre-market approval (PMA) for the Impella RP ...
Abbott Receives FDA Approval for HeartMate 3 Left Ventricular Assist System
Technology | Ventricular Assist Devices (VAD) | August 29, 2017
Abbott announced it has received U.S. Food and Drug Administration (FDA) approval for its Full MagLev HeartMate 3 Left...
Pre-PCI Impella 2.5 Insertion Improves Survival in Left Main Coronary Artery Heart Attacks
News | Ventricular Assist Devices (VAD) | June 30, 2017
Abiomed Inc. announced the recent publication of a peer-reviewed retrospective study on hemodynamic support with the...
Heartware HVAD recall for its ventricular assist device from Medtronic
Feature | Ventricular Assist Devices (VAD) | May 05, 2017
May 5, 2017 — Medtronic Mechanical Circulatory Support is expanding its recall of its HeartWare Ventricular Assist De
Overlay Init