News | August 06, 2008

First U.S. Clinical Trial Implant of DuraHeart LVAS Performed

August 6, 2008 - The first U.S. implant of Terumo Heart Inc.’s DuraHeart Left Ventricular Assist System (LVAS) took place on July 30 at the University of Michigan Cardiovascular Center in Ann Arbor.

National Co-Principal Investigator for the DuraHeart U.S. Pivotal Trial, Francis Pagani, M.D., Ph.D., performed the surgery. DuraHeart is reportedly the world's first third-generation LVAS combining a centrifugal pump with a magnetically levitated impeller to enter clinical trials in the U.S.

"The DuraHeart gives us a new, third-generation option for patients with advanced heart failure who need help to allow them to survive until they can receive a heart transplant," said Dr. Pagani, who leads the U-M Center for Circulatory Support.

The U.S. patient represents the 71st patient worldwide since the DuraHeart European investigational trials began in 2004, according to Terumo. In clinical results as of July 31, 2008, patient support averaged 223 days with cumulative support of 43 years. The longest ongoing patient support is over three years.
The DuraHeart LVAS Pivotal Trial is a multicenter, prospective, non- randomized study of 140 patients and will include up to 40 centers. The device is intended to provide cardiac support for patients awaiting transplant who are at risk of death due to end-stage left ventricular heart failure. Yoshifumi Naka, M.D., Ph.D., from Columbia Presbyterian Hospital in New York, will serve as the National Co-Principal Investigator with Dr. Pagani.

In addition to the U.S. trial, Terumo Heart is expected to initiate clinical trials in Japan this year.
DuraHeart is limited to investigational use only in the U.S., and is CE marked in Europe.

For more information: www.terumoheart.com/

Related Content

Sponsored Content | Videos | Cardiovascular Ultrasound| July 19, 2017
This video educational session, provided in partnership with the American Society of Echocardiography (ASE), is title
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...
Italian Boy Becomes Youngest Patient Bridged to Transplant With SynCardia Total Artificial Heart

Andrei, 12, is the world’s youngest patient to be bridged to transplant with the SynCardia Total Artificial Heart. He is pictured after his heart transplant with his surgeon, Antonio Amodeo, M.D., at Bambino Gesù Children’s Hospital in Rome, Italy. Photo courtesy of Business Wire.

News | Congenital Heart| June 22, 2017
A 12-year-old boy at Bambino Gesù Children’s Hospital in Rome, Italy, has become the world’s youngest patient to be...
Abiomed Impella CP pVAD, third-generation CP
Technology | Hemodynamic Support Devices| June 12, 2017
June 12, 2017 — Abiomed Inc.
tandemLife Tandemheart priming tray cleared by FDA
Technology | Hemodynamic Support Devices| June 12, 2017
June 12, 2017 — TandemLife began its commercial launch of the TandemLife Priming Tray, a new product designed to simp
Sponsored Content | Videos | Cardiovascular Ultrasound| May 26, 2017
This video, provided in partnership with the American Society of Echocardiography (ASE), is titled "Intraoperative Tr
Impella CP study to investigate door to left ventricular unloading time
News | May 09, 2017
May 9, 2017 — The first patient has been enrolled in the U.S.
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
the Impella pVAD improves survival, mortality in AMI heart attack with cardiogenic shock

Early use of the Impella percutaneous ventricular assist device prior to angioplasty may significantly improve survival for patients in cardiogenic shock.

Feature | Hemodynamic Support Devices| April 28, 2017 | Dave Fornell
Recent clinical study data presented at the American College of Cardiology (ACC) 2017 meeting show new treatment prot
Sponsored Content | Videos | Ventricular Assist Devices (VAD)| April 14, 2017
A discussion with William O'Neill, M.D., FACC, FSCAI, medical director of the Center for Structural Heart Disease at
Overlay Init