Technology | July 08, 2008

FDA Approves HeartMate II for Bridge-To-Transplantation


Thoratec Corp. received FDA approval of its PMA (premarket approval) application, allowing the use of its HeartMate II LVAS (left ventricular assist system) as a bridge-to-transplantation (BTT) in patients suffering from advanced-stage heart failure.

The HeartMate II is a mechanical circulatory support device intended for a broad range of advanced-stage heart failure patients. An axial flow device, the HeartMate II can pump up to 10 liters of blood per minute, the full output of a healthy heart, and is designed to provide long-term cardiac support. The device is implanted alongside a patient’s native heart and takes over the pumping ability of the weakened heart’s left ventricle.

It is easier to implant than prior devices, and with only one moving part, the HeartMate II is designed to provide exceptional reliability and improved patient quality of life. The device is designed to have a much longer functional life than the previous generation of devices and to operate more simply and quietly.

Related Content

News | Ventricular Assist Devices (VAD)

April 28, 2022 — The U.S. Food and Drug Administration (FDA) is alerting healthcare providers to the possibility that ...

Home April 28, 2022
Home
News | Ventricular Assist Devices (VAD)

October 20, 2021 – CorWave, a French medtech company developing a next-generation heart pump, won the 2021 HealthTech ...

Home October 20, 2021
Home
Feature | Ventricular Assist Devices (VAD) | By Dave Fornell, Editor

Medtronic announced in June it was stopping the sale and distribution of the Medtronic Heartware HVAD left ventricular ...

Home July 08, 2021
Home
Videos | Ventricular Assist Devices (VAD)

Surgeons at Penn State Heart and Vascular Institute were the second group in the nation to implant a newly-designed ...

Home March 22, 2021
Home
News | Ventricular Assist Devices (VAD)

March 1, 2021 — Medtronic is recalling the HeartWare Ventricular Assist Device (HVAD) Pump Implant Kit because the left ...

Home March 01, 2021
Home
News | Ventricular Assist Devices (VAD)

May 29, 2020 — Medtronic is recalling its HeartWare HVAD left ventricular assist device (LVAD) pump outflow graft and ...

Home May 29, 2020
Home
News | Ventricular Assist Devices (VAD)

January 7, 2020 — Abbott announced U.S. Food and Drug Administration (FDA) approval of a new alternative surgical ...

Home January 07, 2020
Home
Technology | Ventricular Assist Devices (VAD)

September 27, 2019 — Abiomed’s newest heart pump, the Impella 5.5 with SmartAssist, has received U.S. Food and Drug ...

Home September 27, 2019
Home
News | Ventricular Assist Devices (VAD)

September 12, 2019 — CorWave announced successful completion of its first 60-day preclinical study to evaluate its ...

Home September 12, 2019
Home
News | Ventricular Assist Devices (VAD)

August 20, 2019 — Left ventricular assist devices (LVADs) have been shown to help leaky mitral valves that create ...

Home August 20, 2019
Home
Subscribe Now