Technology | March 27, 2007

ACC2: Data from Thoratec’s HeartMate II Pivotal Trial Demonstrates Effective Mechanical Circulatory Support

Data released from the bridge-to-transplantation (BTT) arm of the HeartMate II Pivotal trial demonstrate that the device provides effective mechanical circulatory support as a bridge to transplantation for heart failure patients, and that these patients experience a lower number of adverse events and an improved quality of life while being supported by the device.

The data were presented at a late breaking clinical trial session of the ACC Sessions by Dr. Leslie Miller of Washington Hospital Medical Center/Georgetown University on behalf of the HeartMate II investigators.

The trial involved 133 patients enrolled at 26 centers from March 2005 through May 2006, and the data reported reflect patient follow-up through the end of December 2006. Thoratec completed its PreMarket Approval (PMA) filing seeking approval for the BTT indication at the end of 2006.

The HeartMate II, which has a CE mark allowing for its commercial sale in Europe, is a continuous flow device designed to provide long-term cardiac support for advanced-stage heart failure patients. An implantable LVAS (Left Ventricular Assist System) powered by a rotary pumping mechanism, it is significantly smaller than devices currently having PMA approval, enabling an easier implantation in a broader population of patients. The HeartMate II is designed to have a much longer functional life than other approved devices and to operate more simply and quietly. The device pumps blood through the circulatory system on a continuous basis with only one moving part.

Related Content

Cardiogenic Shock Survival Rates Improve in Three Years Since Impella FDA Approval
News | Ventricular Assist Devices (VAD) | April 05, 2019
Three years ago this week, Abiomed's Impella heart pump received U.S. Food and Drug Administration (FDA) premarket...
HeartMate 3 Pump Shows Superior Outcomes in Advanced Heart Failure
News | Ventricular Assist Devices (VAD) | March 22, 2019
Severely ill patients with advanced heart failure who received the HeartMate 3 left ventricular assist device (LVAD)...
Leviticus Cardio and Jarvik Heart Unveil Wireless Heart Pump System
News | Ventricular Assist Devices (VAD) | February 11, 2019
Heart failure experts at the National Research Center for Cardiac Surgery in Astana, Kazakhstan, recently announced the...
Medtronic Receives FDA Approval for Less-Invasive Heart Pump Implant Procedure
Technology | Ventricular Assist Devices (VAD) | July 17, 2018
Medtronic plc recently received U.S. Food and Drug Administration (FDA) approval for a less-invasive implant approach...
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.
Overlay Init